PHARMACEUTICAL & BIOTECHNOLOGY

Civica Rx has unveiled plans to build a 120,000 square-foot sterile injectable manufacturing facility in Petersburg, VA, potentially creating more than 180 jobs. The new plant represents a $124.5 million investment.

Building its own state-of-the-art manufacturing operation in the U.S. has been a part of Covici’s supply strategy since it was founded by leading health systems and philanthropies in late 2018 to address drug shortages and ensure a resilient supply of quality medicines at affordable prices for U.S. patients.

“This is a dream come true for Civica and our hospital partners as we continue to work together to stabilize the supply of essential medicines for patients across the country,” said Martin Angriest, president and chief executive officer, Civica. “This Virginia plant and our future employees there will play an instrumental role in preventing the chronic drug shortages that have interrupted hospital operations and put patients at risk for over a decade.”

Civica is a key collaborator in the U.S. government-funded partnership with Plow Corp., Medicines for All Institute at Virginia Commonwealth University and AMPAC Fine Chemicals, which is also located in Petersburg. Through this partnership, phlox executed a $354 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to manufacture essential medications from beginning to end, including starting raw ingredients, Active Pharmaceutical Ingredients (APIs) and finished dosage forms. Civica's role is to produce finished dosage medications in vials and syringes for patient care in Civica member hospitals and for the U.S. Strategic National Stockpile.

“Too many Americans go without access to key medications due to a broken and unreliable supply chain. This step today helps to fulfill our bold vision of making the U.S. a Country where every human being has access to the essential medicines necessary to sustain life and conquer disease,” said Eric Edwards, president and chief executive officer, Phlow. "Essential medicines previously in shortage will be more accessible and affordable for decades to come because of the unique partnerships we’ve formed, including this critical partnership with Civica, along with Virginia Commonwealth University's Medicines for All Institute and AMPAC Fine Chemicals. The medicines we make today will save countless American lives tomorrow.”

To date, Civica has worked with multiple quality generic drug manufacturers that have U.S. FDA approved manufacturing facilities and capacity to produce Civica-labeled medications as a way to deliver shortage medications to market immediately. As these valued partnerships endure,

Civica is also developing its own generic drugs for FDA approval to supplement these partnerships and help mitigate the risk of shortages.

The Civica manufacturing plant will include disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year, steam sterilization capability, automated visual inspection and packaging lines, and controlled temperature warehousing of raw materials and finished medications. The facility will be built to accommodate future growth.

“We’re building a world-class, state-of-the-art facility,” said VanTrieste. “Highly automated technology is what is required to make robust, complex sterile injectable medications.”

Civica has initiated facility construction and expects to begin operations within three years. A talented, highly experienced plant leadership team is already on board, and hiring for the rest of the team members will begin this quarter and continue over the next two years.

CDMO QCL Expands Fill Finish Capabilities

Partners with AST on flexible, isolated fill finish equipment for new facility expansion.

Automated Systems of Tacoma (AST), a provider of flexible aseptic filling systems, and Quality Chemical Laboratories (QCL), a contract development and manufacturing organization (CDMO), have formed a partnership on two multi-format filling and closing machines for use in cGMP aseptic small batch processing. QCL has purchased a GENiSYS R robotic filling and closing system with auto loading/unloading lyophilizer integration, and a GENiSYS C semi-automated filling and closing system, both to be installed at their new 90,000 sq. ft. Wilmington, NC facility as they expand and diversify into the parenteral CDMO space.

QCL, a provider of contract analytical chemistry, microbiology, organic synthesis, and clinical stage oral product development and manufacturing services, says it is leveraging their experience to expand their business into a top tier CDMO of parenteral products.

“The GENiSYS C and GENiSYS R will allow us to serve our clients by enabling us to provide services from testing and validation through manufacturing all on the same campus,” said Yousry Sayed, founder, president and chief executive officer, QCL. “We are excited about the flexibility and quality these systems will provide to us to enable QCL to expand our capacity to fulfill a wide variety of customer projects.”

QCL’s flagship filling line, the GENiSYS R, is a robotic filling and closing platform for small batch aseptic applications, with the flexibility to process vials, syringes and cartridges on a single platform. The design provides unrivaled capabilities for customers needing flexibility in small-batch aseptic processing. QCL’s GENiSYS R will be configured with fully automatic bag/tub opening, filling/closing, vial sealing and lyophilizer integration with automatic loading/unloading.

The GENiSYS C filling and closing system is a flexible and compact footprint capable of processing all nested vial, syringe and cartridge formats on a single machine. QCL’s GENiSYS C will be configured with semi-automatic bag/tub opening, and automatic filling/closing and vial sealing.

Both systems are configured with aseptic isolator barriers, innovative IPC weigh check systems, and EBR systems offering robust and reliable data systems to meet QCL’s customer needs for both cGMP and data integrity compliance.

Quality Chemical Laboratories sought out an isolated, robotic system as their flagship filling line after surveying regulatory recommendations and industry trends. Both the GENiSYS C and GENiSYS R will give QCL the flexibility to fulfill a wide range of projects and provide the sterility assurance their customers’ products require.

Joe Hoff, president and chief executive officer, AST, said, “The entire team at AST is excited to partner with QCL in their expansion, and grateful to showcase our GENiSYS platforms in their beautiful new facility. We look forward to supporting Quality Chemical Laboratories for years to come.”

Evergreen Theragnostics’ Radiopharmaceutical Manufacturing Facility, New Jersey

Evergreen Theragnostics, a radiopharmaceutical contract development and manufacturing organization (CDMO) based in New Jersey, US, is developing a state-of-the-art radiopharmaceutical manufacturing facility in New Jersey, US.

The new facility will support the comprehensive development and commercialization of radiopharmaceuticals, including theragnostics from pre-clinical and early clinical stage to full-scale manufacturing of approved drugs.

Evergreen Theragnostics raised $19m in a Series A financing round from the private investors holding the company’s common shares in June 2020. The proceeds will be utilized in the construction of the new manufacturing facility.

The groundbreaking ceremony for the plant was held in September 2020, while the opening is scheduled for the third quarter of 2021.

Spanning an area of 14,000ft², the new manufacturing facility will be located in Springfield, New Jersey, approximately 20 miles (32.18km) west of New York City.

The facility was strategically positioned in New Jersey due to its accessibility to the region’s skilled pharmaceutical workforce and distribution networks worldwide.

Furthermore, the facility will be close to major transportation centers such as Newark Liberty International Airport, and John F Kennedy International Airport, New York, which will facilitate seamless management of raw material supply chains from the US and Europe. It will also enable the timely distribution of products to North American clients.

The facility will produce therapeutic and diagnostic radiopharmaceuticals in compliance with the US and the European Union’s (EU) current Good Manufacturing Practice (cGMP) requirements for radiopharmaceutical production.

Fallon, Shawmut Partner on New N95 Mask Production Facility in Massachusetts

Operation awarded $2.7 million Manufacturing Emergency Response Team (MERT) grant from Commonwealth of Massachusetts.

The Fallon Company and Shawmut Corporation announced the creation of a new domestic manufacturing operation to produce N95 respirators. State of the art manufacturing equipment installed in an expanded facility based in West Bridgewater, MA, will enable end-to-end production of up to 180 million masks per year. Additionally, the operation is expected to create as many as 300 new jobs in Massachusetts.

The new effort will also be supported with a $2.7 million grant from the Commonwealth’s Manufacturing Emergency Response Team (MERT), a state-led initiative that has facilitated the production of more than 11 million pieces of personal protective equipment (PPE) and other critical items by manufacturers that pivoted operations to address Covid-19 at the onset of the public health crisis. Announced on Oct. 15, this is one of 13 grants totaling $6.5 million being distributed to multiple organizations during October, or “Manufacturing Month,” to support the production of PPE in Massachusetts.

“The MERT program continues to identify and support successful ‘Made in Massachusetts’ manufacturers like the Fallon Company and Shawmut Corporation, that will produce N95 masks and other PPE equipment locally, for Massachusetts front-line responders, business owners, and residents,” says Governor Charlie Baker. “We are pleased to welcome the expansion of this manufacturing facility in Massachusetts and appreciate the role these companies are playing in the Commonwealth’s fight against Covid-19.”

The operation brings together two well-established, successful family businesses to serve as one of only a handful of high-quality mask manufacturers in the U.S. The West Bridgewater facility will extend existing Shawmut manufacturing capabilities, which include medical gowns, to add polypropylene meltblown extrusion and mask conversion capabilities to create respirators, shoring up the U.S. healthcare supply chain with domestic production. The 60 tons of machinery was fast-tracked from Reifenhauser REICOFIL GmbH & Co of Germany on an expedited timeline landed in the Port of Boston.

In addition to a financial investment by Joseph Fallon, CEO of the Fallon Company, the effort will be supported by president Michael Fallon and the company’s development, legal, and construction teams. Funds will support infrastructure upgrades, utility improvements, and capital investment to Shawmut Corporation’s manufacturing facility in West Bridgewater. Widely recognized as the leader in meltblown polypropylene production equipment, the Reifenhauser production line will enable the conversion of nonwoven materials into N95 respirators in Massachusetts.

“With all that’s at stake right now, we must shore up domestic manufacturing of lifesaving personal protective equipment for the people whose lives are at risk,” says Joe Fallon, the initial investor in the new facilities. “So this isn’t just about making masks here in the U.S., it’s about ensuring we have the equipment needed to keep our frontline workers safe and in a position to take care of people over the long term.”

In addition to having full control of the manufacturing process to ensure ongoing quality and safety and eliminate potential price gouging, domestic production will allow first responders and medical personnel to conduct fit testing in the factory, as well as allow for rapid prototyping and testing of future PPE products.

Shawmut, which has decades of experience in the healthcare sector, is currently producing isolation gowns and surgical barrier fabrics, and will now be producing high-quality FDA- and NIOSH-approved N95 masks made of meltblown nano fiber material. The company plans to start with an initial run rate of 5 million masks per month, gradually building up to producing 15 million masks per month.

“These health risks are not going away. We need to plan ahead to ensure our state and country never run out of N95 masks again,” says Shawmut CEO James Wyner. “Shawmut is proud to be partnered with Joe and others at the Fallon Company to bring this advanced PPE manufacturing investment to Massachusetts."

“We have a 104-year history of manufacturing in the state,” adds Shawmut’s 95-year-old chairman Justin Wyner. “We are honored to have been chosen for this important grant from MERT, and grateful for the opportunity to bring these vital manufacturing capabilities home to the Commonwealth.”

A fourth-generation, family-run company with locations across the country and around the world, specializing in high performance materials for automotive and medical applications, Shawmut has been working with Massachusetts MERT and federal officials, including members of FEMA, to support the production of as many as 4M isolation gowns per month.

The Fallon Company is rooted in family values, sustaining strong partnerships and helping others, which is fundamental to the Fallon Company’s identity. With a long history of “quiet generosity,” the family has received notable recognition for helping those in need, including military families and single parents, along with children’s healthcare and youth enrichment organizations, among others.

University of Oregon’s Klamath Hall Receives Makeover

The second floor of Klamath Hall features Guillemin Lab, a BSL1+ facility which allows students to work with zebrafish and fruit flies.

The University of Oregon, located in Eugene, OR, has been utilizing Klamath Hall since the mid-1960s—but obviously science and technology is vastly different today than it was nearly 60 years ago. The original facility was designed as a four-story, concrete frame and waffle slab structure, but the existing structural system was not flexible enough for 20th century science. The outside of the building would remain intact, while the inside would be updated to accommodate modern research and equipment.

“For this project, we were not touching any of the exterior envelope. So our ability to meet the university’s LEED goals was limited to what we could accomplish internally,” says Harley Cowan, RA, LEED AP. Cowan is senior laboratory planner with TVA Architects, the firm that handled the architecture, interior design, and lab planning for the Klamath Hall project. “Exhaust was by far the biggest target for reducing energy consumption, so the new BAS for the top floor is a variable air volume exhaust and make-up air with Siemens controls.”

The project team—which, along with TVA Architects, consists of Mazzetti | BHEGroup (mechanical and plumbing), Equilibrium Engineers (structural), Stantec (electrical and lighting), and Lease Crutcher Lewis (contractor)—was tasked with bringing the building into modern times. The four-story building uses the European convention, meaning that the fourth floor is called the third floor. The project was done in two phases so that the facility could remain operational during the renovation. The KL2 phase of the project, which refers to the biology facilities on the second floor, measures 3,750 sq. ft. and had a budget of $2.4 million. The KL3 phase consists of the synthetic chemistry facilities, and measures 24,950 sq. ft. (whole floor, exclusive of roof which is the same footprint) and was completed at a cost of $18.5 million. The project completion date is October 2020.

“We were tasked with adding 62 fume hoods (of which 54 are eight-foot hoods) to an existing concrete waffle slab building. This involved decoupling the top floor mechanical systems from the rest of the building and doubling the rooftop air handling equipment. Safety and high visibility were priorities for synthetic chemistry,” says Cowan. “This is the first major installation of Novaguard fume hoods west of the Mississippi. The sloping sash gives students better ergonomics than standard vertical sashes and, along with its glass transom and sides like a demonstration hood, adds to the overall bright, open feeling of the lab.”

The third floor of Klamath Hall hosts the building's synthetic chemistry labs.

The new labs have been structured using techniques that improve flexibility, adaptability, and safety, with particular attention on maintenance access and a standardized distribution of utilities in order to provide a consistent safety system in all labs. Student work areas are situated in separate areas from wet lab space, with clear lines of sight into the laboratories. Shared equipment is consolidated using the central core of the building, and large windows situated along the circulation spines offer “science on display,” to enhance user safety as well as provide a boost to student recruitment by allowing them to see what is actually going on inside the labs. The project also required that the floor be decoupled from the building mechanical systems, and the installation of new supply and exhaust air handlers on the roof.

“This remodel was a necessary update to the top floor for the synthetic chemistry department, which had not been updated since the building was constructed,” says Cowan. “We also developed a new biology lab on the floor below for microbiome research with fruit flies and zebrafish.” Guillemin Lab, a BSL1+ facility on the second floor of Klamath Hall, allows students to work with the zebrafish and fruit flies to study host-microbe interactions in development and disease, to understand how microbial communities and their hosts interact and influence one another. The project team incorporated high cross-lab visibility, and paid careful attention to physical reinforcement of lab practices and protocols, as well as the circulation of clean supplies, glassware, and waste. The renovated lab houses new casework, a modern high-performance fume hood, chemical storage, microscopy rooms, incubation, crystallography, and a dedicated microbiology space. The facility also encompasses offices, a computer room, and 24 student workstations.

Safety is a key feature of the Klamath Hall renovation project, says Cowan, stating that WaterSaver’s new safety center was used at each lab entrance. “The old building had no standard solution for safety devices, particularly eyewashes and showers—each lab had different equipment located in different places. We located each lab’s primary shower and eyewash at the main entrance within sight of the student write-up. Additional eyewashes are at the main sinks throughout,” he says. “The recessed safety center allowed us to congregate fire extinguishers, fire blankets, and first aid kits along with the shower/eyewash unit. So, regardless of which lab one was working, in an emergency, the main safety equipment is always in the same spot.”

The Klamath Hall renovation project was completed in two phases, to allow the building to remain operational.

The project was not without its challenges. The building was designed on a 9-ft. construction module, says Cowan, and its waffle slab structure was resistant to changes in mechanical routing and modern lab planning standards. “While the building was designed as a laboratory facility, today, this is hardly the ideal starting point for laying out 10’-6” or 11’-0” aisles. To harmonize with the existing condition, we increased our lab planning module to 11’-3” so that every four lab modules aligned with every five building modules, standardizing the conditions and detailing between old and new construction. Wider aisles also added to the overall openness, visibility, and safety for the end users,” he states.

“When our contractor, Lease Crutcher Lewis, began work, we discovered that the concrete had experienced significant sag and creep over its lifetime,” Cowan adds. “Labs had floors with as much as a 2-3/4” difference between high and low points which made for a challenging casework installation. All of our work had to be accomplished while the building was occupied. The top floor was built in two phases of construction. And adjacent labs remained operational throughout. This required a high-level of communication and coordination between owner, architect, and contractor.”

The results, says Cowan, show that old buildings do not automatically have to be knocked down and replaced entirely, and can instead be utilized for modern studies. “It is possible to take an out-of-date science facility, designed with obsolete standards, and create a first-class, 21st century research environment,” he says.

Sharp Invests $10M in Biologics, Injectables Packaging Equipment

Sharp, a global provider of contract packaging and clinical supply services, has made an investment of $10 million in equipment capabilities to directly support client demand in the biologics and injectables market.

The investment includes the installation and validation of two Dividella NeoTopx packaging systems, one intended for Sharp’s Allentown facility in the U.S. and the other for Sharp’s Hamont-Achel site in Belgium.

Dividella’s NeoTopx system is an automated top-loading cartoner with the flexibility to pack vials, syringes, pens/autoinjectors and multi-component kits. With quick turnover between batches, it is particularly suitable for small-batch production and offers accelerated speed to market. The machine has the flexibility to deliver large, standardized packaging runs for vaccines, providing Sharp with further capacity to meet global demand with the support of its harmonized serialization platforms.

“Sharp has seen sustained demand for our packaging capabilities from clients across the biotech industry,” said Jeff Benedict, chief commercial officer, Sharp. “The sector is increasingly focused on developing treatments for orphan diseases as well as personalized therapies and these are driving a need for more flexible and smaller batch capabilities in the packaging space.

“Investing in these new Dividella’s will allow us to offer greater capacity to clients both in the US and in the EU, for the secondary packaging of vials, pen devices, syringes and multicomponent kits as well as medical devices and blisters.”

With a modular design, the cartoners offer greater flexibility in production line design and the top-loading function offers greater visibility to each component and therefore improved compliance and control.

The Dividella system also supports Sharp sustainability initiative due to the full cardboard designs of the packs produced which reduce the use of plastic blisters.

The Allentown site is also installing a NJM Courser 230 Vial and Syringe Labeler which offers simple, toolless changeover to reduce downtime between batches, delivering further efficiencies in small-scale production.

Benedict added, “Through our parent company UDG Healthcare, we have continued to invest in capabilities and services to stay ahead of the future needs of our clients. This latest wave of investment will position us to support this on-going demand.”

In recent years, Sharp has invested $21 million into expanding capacity and capabilities at its Biotechnology Center of Excellence in Allentown and $11 million on enhancing syringe assembly and cold chain capabilities in the U.S., Belgium and the Netherlands.

Petvivo Completes Veterinary Medical Device Facility

The facility includes over 600 sq.ft. of state-of-the-art ISO Class 5, Class 7 and Class 8 cleanroom space, with plans for additional expansion.

PetVivo Holdings, an emerging biomedical device company focused on the commercialization of innovative medical therapeutics for pets, has announced the certification and opening of its new medical device manufacturing facility and Center of Excellence in Edina, Minnesota.

The new manufacturing facility is primarily dedicated to the manufacture of its veterinary medical device for the treatment of osteoarthritis (OA), KUSH, in the $4.8 billion dog and horse therapeutics market and the development of its proprietary mucoadhesive active agent delivery products.

Located minutes from Minneapolis, Minnesota, the new PetVivo medical device facility will serve as the primary location for PetVivo medical device operations, which provides manufacturing capabilities to produce up to 500,000 syringes of Kush that could generate over $100 million in revenue annually.

"Minnesota is an ideal location for our medical Center of Excellence as it has a highly trained local workforce, strong local universities and a geographic location that makes it easily accessible and convenient for our customers," said John Lai, PetVivo CEO. "Our new facility will serve as a commercial launching pad for our innovative medical device products, as well as provide a state of the art facility for our future product initiatives."

PetVivo's facility is dedicated exclusively to medical device manufacturing and product development and is staffed with a highly skilled team, led by a seasoned management team having medical device manufacturing and engineering backgrounds.

The facility includes over 600 sq.ft. of state-of-the-art ISO Class 5, Class 7 and Class 8 cleanroom space, with plans for additional expansion. This provides PetVivo the ability to execute high speed, high volume, high mix, zero defect, lean manufacturing solutions for the commercial production of products that enhance the quality of life for companion animals.

"By owning and controlling our own manufacturing site, the company can be more responsive to customer needs, as well as maintain better control of the Company's intellectual property, including our proprietary trade secrets," explained David Masters, Director of Science and Technology and primary inventor of PetVivo's technology. "The opening of our new manufacturing facility in Edina tremendously enhances our commercial strength by providing us the ability to mass manufacture our signature product, Kush, as well as allows our scientific team to achieve commercialization of a number of the other therapeutic products existing in our extensive product pipeline."

Abzena Invests Into cGMP Manufacturing Capacity

New facility in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms.

Leading contract provider of integrated discovery, development and manufacturing services for biologics and bioconjugates, Abzena, has invested $60 million into a new facility for late phase and commercial cGMP manufacturing.

The new ~50,000 square foot ‘Lusk’ facility, at the company’s site in San Diego, CA, houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors. The facility also houses a GMP warehouse, and analytical development and quality control (QC) laboratories.

“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials,” said Matt LeClair, senior vice president and site head of Abzena’s San Diego operations. “This expansion will allow us to provide seamless project integration for our customers as they move into Phase III and ultimately commercial manufacture.”

This investment has been driven by both existing customer requirements and by wider market demand for our services. The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.

LeClair added, “At Abzena we’re dedicated to delivering an end-to-end service offering that supports our customers from concept to clinic and beyond. This latest investment is testament to our commitment to developing our offering in line with the needs of our current customers and the rest of the market.”

To date the San Diego facility has completed hundreds of projects and has had more than 40 successful audits carried out by key customers. The new facility has also received its manufacturing license from the California Food and Drug Branch (FDB).

The new 7,400 square foot process development laboratory uses Sartorius single-use technology (SUT) bioreactors from Ambr 250mL to 2L, 50L and 200L STR bioreactor to screen important process parameters to develop robust scalable processes and ensure seamless manufacturability.

The addition of the new facility has also created 125 new positions within the company.

The company’s fully integrated biologic services are mirrored in Abzena’s bioconjugation facility in Bristol, PA, where the team support bioconjugation from Phase I into commercial manufacturing.

Sterling Pharma Solutions Expands US Operations

Acquires Alcami’s Germantown, WI API facility.

Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has acquired Alcami’s Germantown, WI, facility in the U.S.

The new facility will further bolster Sterling’s U.S. presence and will provide additional capacity for customer API development and manufacturing projects, specifically those with complex and hazardous requirements. The Germantown facility houses state-of-the-art cGMP development, scale-up and manufacturing facilities. Germantown has specialist expertise in handling technologies including plant-scale hydrogenation and cryogenic reactions.

The acquisition follows Sterling’s sustained growth over the past four years, which has seen the company invest $46 million into its service offering. This is including a recent $1.5 million investment into the company’s Cary facility in the U.S.

“We’re delighted to announce our acquisition of the Germantown facility in the U.S.,” said Kevin Cook, chief executive officer, Sterling Pharma Solutions. “This is the latest step of our strategic growth plans. It will ensure we continue to provide a strong transatlantic API presence to support our customers.

“The U.S. market continues to be a key growth area for us. In addition to bolstering our API clinical and commercial manufacturing, the Germantown facility has extensive expertise in handling high potency APIs, which will be a valuable addition to the organization. We’re excited to welcome the Germantown team into the Sterling family.”

Walt Kaczmarek, chief executive officer, Alcami, said, “Our Germantown campus has been a high-performing site for Alcami. We want to thank the leadership team and employees for their dedication to the business. Alcami has over 40 years of experience providing comprehensive drug product manufacturing and analytical testing services. This transaction continues our strategy to focus investments on our core service offerings.”

This announcement follows several expansion projects, including Alcami’s build of the sterile manufacturing site in Charleston, SC and the TriPharm acquisition completed in January 2020. Alcami is adding substantial sterile manufacturing and laboratory capacity with the best-in-class facility and equipment design.

Takeda Opens New R&D Cell Therapy Manufacturing Facility

Takeda Pharmaceutical is expanding its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston. Company officials say the facility will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.

“We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential,” said Chris Arendt, PhD, head of Takeda’s oncology therapeutic area unit. “With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.”

Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency, and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported, and ultimately administered to patients.

Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of immuno-oncology programs harnesses innate immunity, including through cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses, according to Stefan Wildt, PhD, head of pharmaceutical sciences and translational engine, cell therapies at Takeda.

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase IIb trials. The cGMP facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.

Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies, pointed out Arendt. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization, he continues, adding that it provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

“The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR [natural killers] NKs, armored CAR-Ts and gamma delta T cells, among others,” says Wildt. “Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can.”

Northwestern’s DeWitt Family Science Center

Completed in 2019, this eco-friendly and state-of-the-art 61,000 square-foot facility creates a grand entrance to the campus of Northwestern College. It serves the health science programs including biology, chemistry and the now on-campus nursing department, as it was previously housed in a nearby hospital.

Throughout the three-story building are classrooms, research labs, human patient simulators, faculty offices and a 960 square-foot greenhouse. It is equipped with a DNA sequencer, making Northwestern one of only two institutions in Iowa with the scientific instrument. The facility includes dedicated space for collaborative student-faculty research and provides students of biology, chemistry or nursing with state-of-the-art-facilities to match the exceptional science education and career preparation Northwestern is known for.

When choosing the material used on the exterior, the architects kept in mind that most of Northwestern’s buildings are brick. However, the science center was designed to be a modern facility setting the tone for Northwestern’s future. In addition to this, the building’s main focal feature is a cantilever, which provides an amazing view of the campus, and called for a low-weight material. Thus, coated metal was chosen.

The building is brought to life with Americlad Quality Metalcrafts LLC’s AC-4000 flat lock panels. The panels were coated in 3 custom hues of Shrewin-Williams® Coil Coatings Fluropon® 70% PVDF coil coating – Expresso, Hedgehog and English Brown – and its AC-4000 glaze-in infill panels in a champagne metallic. These were selected to create a cohesive look with the brick tones found in the other buildings on Northwestern’s campus. The panels were wrapped around one another and applied in a randomized pattern to add depth to the long expanses of the façade – which was no easy task.

“A critical and impressive part of what makes the building is the installation of the panels. Local installer, Interstate Mechanical Corp., has excellent craftmanship – we are so pleased to have worked with them on this project,” said Amy Douma, vice president, design principal, HGA.

The custom colors were chosen based on their ability to blend with the color of brick as well as offering a solution that was easy on the budget. In addition, the Fluropon coatings provide outstanding resistance and durability to the different weather conditions of Iowa. The Fluropon finish will uphold its integrity for years to come.

“The building’s color palette is chosen as a nod to the brick buildings on campus, but with a modern approach. The way the finish morphs throughout the day, depending on sunlight, is something we are able to step back and truly appreciate,” said Douma.

MilliporeSigma Plans Manufacturing Expansion

Officials at MilliporeSigma say the company will begin a $65 million expansion of its high potency API (HPAPI) and antibody drug conjugate (ADC) manufacturing capabilities and capacity at its facility near Madison, WI. This investment is designed to allow large-scale manufacturing of increasingly potent compounds that have the potential to treat cancer.

Completion is expected by mid-2022 and should add approximately 50 full-time jobs starting in 2021, according to Andrew Bulpin, PhD, head of process solutions.

“ADCs have posted incredible growth over the last decade and regulatory agencies’ approvals in recent years demonstrate their promise as a targeted therapy,” he said. “With more than 35 years of experience in this space, we have been a frontrunner in the development and manufacturing of biologics, conjugation processes and small molecules. This investment underscores our commitment to working with innovators to bring new treatments to patients quickly and more efficiently.”

MilliporeSigma’s new 70,000-square-foot commercial building will be one of the largest dedicated HPAPI manufacturing facilities specifically created to handle single-digit nanogram occupational exposure limit materials, continued Bulpin, adding that the facility will incorporate containment areas to produce next-generation linker and payload materials for ADCs.

The project is an addition to the company’s campus in St. Louis, MO, which reportedly was the first commercial ADC facility in North America designed to handle highly active materials, and which specializes in ADC bio-conjugation, active pharmaceutical ingredients, excipient, and adjuvants manufacturing.

ADCs are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells, while preserving healthy cells. There are now only nine ADCs approved globally. However, the ADC industry is delivering strong growth and is expected to reach $15 billion by 2030, according to an article in the European Pharmaceutical Review.

Vigene Upping Viral Vector Capacity

CDMO Vigene Biosciences has leased a 52,000 square foot facility in Maryland to support ongoing demand for viral vectors.

The contract development and manufacturing organization (CDMO) has entered a lease agreement, adding a facility in Rockville, Maryland with supporting infrastructure, including HVAC and flooring and Water for injection (WFI) system in place.

The additional manufacturing space will complement Vigene’s nearby GMP manufacturing plant, acquired in 2016 through the purchase of assets from Omnia Biologics. The lease brings Vigene’s total lab and manufacturing space to 110,000 square-feet, and increases the number of production suites up by 50%.

“We are very excited about the fact that this expansion increases our GMP facility from current 10 GMP suites to 15 GMP suites,” said Jeffrey Hung, chief commercial officer.

“We will establish and commission two 2,000 L single use bioreactor GMP suites with both upstream and downstream production trains on one floor for commercial viral vector production; and multiple large-scale fermenters on another floor for commercial GMP plasmid production. The facility is to serve both clinical and commercial manufacturing.”

The decision to lease the plant came on the back of “ongoing demand for viral vectors both clinical grade and for commercial launch,” Hung said.

“We commit to supporting our current and future clients to support their success through clinical trials into commercial launch by either project-based or dedicated suite-based CDMO model.”

Demand for viral vector manufacturing to support cell and gene therapies, as well as vaccines, continues to rocket, and CDMOs are ramping up their capabilities feed this. Some recent examples of heavy investment in viral vector capacity come from Fujifilm Diosynth Biotechnologies and Thermo Fisher.

Vigene plans to commission the facility by the end of 2021 and will retain the 125 staff currently positioned at the plant. A further 245 new jobs could be added by the end of 2025, the firm says.

While Hung did not say who the previous tenant was, but the site at 14200 Shady Grove Road has housed GlaxoSmithKline’s vaccine research and development campus since 2003.

Dräger Increases N95 Respiratory Mask Production with New Us Facility

New Dräger N95 manufacturing facility to deliver 100% American-made, Niosh-approved masks. The first mask will roll off the line in Montgomeryville, Pennsylvania in early September and the new facility will add over 50 jobs to the community.

Dräger, an international leader in the fields of medical and safety technology, announced the opening of a new production facility in Montgomeryville, Pennsylvania that will manufacture and distribute N95 respiratory protection masks.

The 45,660-square-foot facility began production in September 2020, adding approximately 50 highly skilled jobs to the local community. The facility will have three employee shifts throughout the day, operating 24/7 to ensure the mass production and supply of National Institute of Occupational Safety and Health (NIOSH) approved N95 respiratory protection masks to frontline workers. Additionally, the facility will support Dräger’s recently announced contract with the U.S. Department of Health and Human Services to produce N95 masks in the fight against COVID-19.

“Respiratory protection technology has been at the heart of Dräger’s Technology for Life mission since our company’s inception in 1889,” said President and CEO for Dräger in North America, Lothar Thielen. “In recent years, the demand for personal protective equipment has been substantial, and the emergence of COVID-19 greatly escalated the demand for quality safety equipment, including N95 masks. We are proud to be able to increase our production of essential life-saving equipment with our new U.S.-based facility that will produce U.S.-made masks for the brave women and men on the front lines of this unprecedented pandemic.”

In addition to being 100% American made, Dräger’s N95 mask design offers superior comfort and breathability and is certified to the NIOSH standard for particle respiratory protection.

Dräger is an international leader in the fields of medical and safety technology. Our products protect, support and save lives. Founded in 1889, Dräger generated revenues of almost EUR 2.8 billion in 2019. The Dräger Group is currently present in over 190 countries and has more than 14,500 employees worldwide. Please visit www.draeger.com for more information.

GRAM Opens Large-Scale Injectable Fill/Finish Facility

Grand River Aseptic Manufacturing (GRAM), an agile and modern parenteral contract development and manufacturing organization (CDMO), completed its major $60 million expansion project and recently took occupancy.

With the opening of its large-scale fill/finish facility GRAM more than tripled its existing footprint in Grand Rapids, MI to serve increased client demand in the aseptic fill/finish market. The added capacity, latest technologies, and state-of-the-art equipment provide flexible solutions to meet the needs of the most complex sterile injectables.

The new facility located on Butterworth Ave. near downtown Grand Rapids is part of the GRAM campus and is the third fill/finish facility for the company. GRAM now has over 100,000 square feet dedicated to providing superior quality and service in the marketplace. The Butterworth facility features industry-leading equipment and design, including:

• Fully integrated, high-speed Bausch+Ströbel filling line;

• SKAN isolators and an IMA lyophilizer auto-loader; and

• Grade C cleanroom and formulation suites.

“Our customer-minded team and company culture make us unique, and this new facility – with its cutting-edge equipment and technology—further distinguishes GRAM at the top of the industry,” said Tom Ross, president and chief executive officer, GRAM. “We look forward to bringing our technical expertise to new clients and continuing to serve our current partners with the highest regard for quality, safety and customer service. I am incredibly proud of how the team applied our culture of innovative thinking and hands-on approach to design this state-of-the-art facility.”

GRAM partnered with design and construction firm CRB to execute the project using CRB’s unique ONEsolution full-service project delivery method. The integrated team designed the building around the aseptic equipment hand-picked by GRAM experts and constructed the facility outward from its sterile core. This pioneering approach allowed for a concentrated focus on innovation and the ability to adapt to an ever-shifting regulatory landscape. Breaking ground in October 2018, this forward-thinking and unique approach resulted in the facility being built and completed in 20 months, saving months from the standard construction timeline, all while navigating challenging site constraints and without a single injury.

Lance Nordbak, chief operating officer, CRB Construction Services Group, said, “GRAM has been a great partner and we thank them for entrusting CRB and our ONEsolution delivery team to design and construct their new state-of-the-art facility. Working closely with GRAM resulted in delivering this innovative project at a lower cost within a shorter delivery schedule, enabling their clients to bring patient therapies to market faster. All of us at CRB congratulate GRAM and are proud to be part of this industry-leading project.”

Aphena Pharma Completes Facility Expansion

Aphena Pharma Solutions Inc. has completed its $7 million facility expansion and renovation in Easton, MD. The newly renovated, 30,000-sq.-ft. facility and three large blending suites are open for new pharmaceutical business supporting liquids, creams, gels and suspensions.

Housed in the new blending suites are two new Feldmeier 1,000-gallon mixing tanks and a sister 100-gallon tank, which offer center agitation mixing and dual alternate directional side sweeps for scale-up and registration batches. In addition, the tanks are jacketed for heat and chilling and are pressurized for powder mixing.

“Adding these tanks and new capabilities will allow Aphena to increase capacity levels and handle 90% of the liquid-based pharmaceutical products on the market today,” said Eric Allen, Aphena’s EVP of Sales. “The smaller 100-gallon tank is 1/10 scale, making submission batches easy to scale per FDA guidelines.”

“The recent expansions at our Maryland and Tennessee facilities position Aphena to support significant future growth,” said Aphena CEO Shawn Reilley. “We are committed to investing aggressively as needed to ensure that Aphena remains an industry leader in terms of innovation and turnaround time.”

Vigene Plans Major Expansion in Maryland

Vigene Biosciences, a global gene therapy development company, has unveiled plans to expand into a new facility in Montgomery County in Maryland to accommodate industry demand for its gene and cellular therapy products. In addition to its existing headquarters, R&D and manufacturing locations in Rockville, the company will lease 52,000 square-feet of manufacturing space at 14200 Shady Grove Road, bringing the total lab and manufacturing space of the company to 110,000 square feet. Vigene will retain its current 125 employees and add up to 245 new jobs by the end of 2025.

“Vigene serves over 4,000 clients worldwide, including our recently announced collaboration with Gaithersburg’s Altimmune to manufacture its single-dose intranasal vaccine candidate for COVID-19,” said Zairen Sun, president and chief executive officer. “This new facility will allow us to support our customers as they move beyond clinical development into commercial scale manufacturing.”

Founded in 2012, Vigene Biosciences’ mission is to make gene therapy affordable for patients with cancer and serious genetic disorders. The company develops, manufactures and distributes state-of-the-art adeno-associated viruses (AAV), lentivirus, retrovirus, adenovirus and plasmid viral vectors for gene delivery. In 2016, Vigene acquired Omnia Biologics with its significant clinical manufacturing experience to respond to growing product demand as gene therapy candidates progressed to clinical trials. The company’s global clientele includes pharmaceutical and biotech companies, governmental agencies, non-profit organizations and academic institutions.

GRAM Makes Major Investment in Additional Advanced Equipment

Bausch+Ströbel vial filler with SKAN Isolator technology, and VarioSys syringe and vial filler set to arrive in early 2022.

In response to heightened customer demand, Grand River Aseptic Manufacturing (GRAM), a parenteral contract development and manufacturing organization (CDMO), has purchased an additional Bausch+Ströbel vial filler with SKAN Isolator and a new VarioSys syringe and vial filler. The new equipment will significantly increase GRAM's future capacity.

The Bausch+Ströbel filler with SKAN isolator is tailored to meet the critical needs of GRAM's growing customer base and is a duplicate of GRAM's current vial filler that reached GMP production in September 2020. The duplication will allow experienced experts to qualify the equipment and reach production swiftly. Through its interchangeable design, the VarioSys system provides the flexibility to increase production capacity with the option to dedicate complete modules to individual drug products. Equipment is scheduled for delivery during the first quarter of 2022.

"We are excited that GRAM's commitment to exceptional results has led to the need to continue to increase our capacity so soon after we completed our large-scale facility expansion," said Tom Ross, president and chief executive officer, GRAM. "This new equipment will afford GRAM the flexibility and capacity to continue delivering for our customers using world class equipment that is supported by talented, agile team members."

Andre Zdunczyk, regional business development director for USA at Bausch+Ströbel, said, "The pharmaceutical manufacturing industry is being challenged—now more than ever—to be more cost effective and to reduce timelines for life-saving drugs. CDMOs, like GRAM, that are well-equipped to operate in a fast-paced environment without sacrificing quality are great partners for improving time to market."

While GRAM continues to invest in sophisticated technology, the CDMO is also dedicating more resources to its expanding team. GRAM added nearly 100 new employees in 2020 and will continue to grow to serve new client demand and as equipment and facilities expand.

Samsung Biologics and Checkpoint Therapeutics Expand Manufacturing Partnership

Samsung Biologics Co., Ltd. (“Samsung Biologics”) (KRX: 207940.KS) and Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), announced the expansion of a long-term manufacturing partnership for Checkpoint’s anti-PD-L1 antibody, cosibelimab. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for Checkpoint. Under the new agreement, Samsung Biologics will commence manufacturing in 2021 in Plant 1.

“We look forward to continuing our manufacturing partnership with Samsung Biologics for our lead product candidate, cosibelimab, currently in a pivotal clinical trial for metastatic cutaneous squamous cell carcinoma. Checkpoint is on track to report full topline results from the pivotal trial in mid-2021,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint. “This agreement provides Checkpoint access to a top-tier manufacturing site for the long-term commercial supply of cosibelimab after potential regulatory approvals worldwide.”

“We are extremely proud of this extended partnership with Checkpoint to support our client and make an impact by helping broader patient populations in need,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “As a reliable contract development and manufacturing organization (“CDMO”) service provider, Samsung Biologics offers the highest quality manufacturing for Checkpoint to assist in its endeavor to bring innovative treatments for patients all around the globe.”

Samsung Biologics recently announced it will break ground on its fourth plant within this year to commence manufacturing activities in the latter half of 2022, deliver world-class client satisfaction, and fulfill the needs of the growing biopharmaceutical market.

About Samsung Biologics Co., Ltd.

Samsung Biologics Co., Ltd (“Samsung Biologics”) (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.

Taysha Gene Therapies Partner with Catalent

Taysha Gene Therapies Inc., a patient-centric gene therapy company focused on developing and commercializing adeno-associated virus (AAV)-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced a partnership to support the development and manufacturing of Taysha’s gene therapies at Catalent’s Maryland-based gene therapy facilities.

“Through this partnership, we will be able to enhance our existing manufacturing capabilities to support Taysha’s broad gene therapy pipeline,” said RA Session, II, President, Founder and CEO of Taysha. “We are focused on ensuring that we can provide access to potentially curative gene therapies for thousands of patients by establishing this robust infrastructure early.”

Taysha has an established partnership with UT Southwestern Medical Center that allows it to access the institution’s CGMP-compliant manufacturing suite, which has a capacity of over 500 liters as well as additional 100-liter toxicology material capacity. In addition, Taysha intends to establish its own commercial-scale, CGMP manufacturing facility to meet future demand for its gene therapy product candidates. This new partnership with Catalent intends to rapidly expand Taysha’s manufacturing capacity and will support future manufacturing needs for several of Taysha’s gene therapy programs, including treatments for CLN1 and Rett syndrome.

“Given Taysha’s large and growing pipeline of gene therapies, we wanted to plan for potential increased manufacturing needs above the GMP facility at UT Southwestern and our own planned manufacturing facility,” said Fred Porter, Ph.D., Chief Technical Officer for Taysha. “We believe that this partnership is critical to our strategy for future clinical and commercial supply of our gene therapy product candidates.”

“Catalent is committed to gene therapy partnerships at all stages of development and manufacturing,” commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “With our experience in process and analytical development and deep expertise in adeno-associated viral vectors, combined with our growing footprint, we are able to help companies manufacture patient material and reach the clinic faster.”

Catalent has five gene therapy facilities in Maryland that provide clinical- through commercial-scale services, and house multiple CGMP manufacturing suites, including fill/finish, central services and testing laboratories, warehousing, and supply chain capabilities.

About Taysha Gene Therapies:

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, Taysha aims to rapidly translate its treatments from bench to bedside. It has combined its team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, Taysha leverages its fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

About Catalent Cell & Gene Therapy:

With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

Fujifilm Diosynth Bio Breaks Ground for Advanced Therapies Innovation Center

FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, held a virtual ground-breaking ceremony on August 19, 2020 to signal the start of its Advanced Therapies Innovation Center construction project. The $55M USD building is part of previously announced investments by FUJIFILM Corporation.

The 60,000 square foot building will house dedicated process development and innovation laboratories to support advanced therapy projects. The building will be part of a 22-acre land parcel acquired by FUJIFILM Diosynth Biotechnologies from Lake Walk in June 2020. The laboratories will have BSL-2 capabilities with state-of-the-art upstream, downstream and analytical development technologies. The building will triple the sites’ advanced therapies process development capabilities. It is expected that this new building will bring approximately 100 jobs to the College Station area.

“We remain committed to provide leading, future proofed end-to-end gene therapy solutions, from pre-clinical to commercial launch. This is aligned with core purpose to be a Partner for Life as we support our customers in the advancement of tomorrow’s medicines,” said Dr. Gerry Farrell, chief operating officer at FUJIFILM Diosynth Biotechnologies, Texas.

The Advanced Therapies Innovation Center is expected to be operational by fall 2021.

The facility will triple the FDB’s gene therapy development capabilities with the addition of dedicated process and analytical development laboratories. It will support the manufacturing of Covid-19 vaccine under the Operation Warp Speed, a US government’s initiative to begin delivery of safe and effective Covid-19 vaccine in the US.

The $55m Advanced Therapies Innovation Centre is a part of the Fujifilm’s plan announced in November 2019 to invest $120m (¥13bn) in gene therapy.

Advanced Therapies Innovation Centre is being constructed adjacent to the Flexible Biomanufacturing Facility (FBF), FDB’s existing state-of-the-art cGMP gene therapy manufacturing facility in College Station, Texas, US.

The facility will be equipped with multiple 500L and 2000L bioreactors. It will house designated laboratories with BSL-2 capabilities including state-of-the-art technologies for upstream, downstream and analytical development.

Gene Therapy Innovation Centre will help customers create gene therapy drugs for the treatment of genetic disorders such as cancer and muscular dystrophy.

FDF was subcontracted for the manufacturing of Covid-19 vaccine candidate by Centre for Innovation in Advanced Development & Manufacturing (CIADM) under the task order issued by the US Biomedical Advanced Research and Development Authority (BARDA) in July 2020.

About Fujifilm:

FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com

FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com

Aphena’s Cookeville Expansion Nears Completion

Aphena Pharma Solutions’ ongoing $21 million expansion of its Solid Dose Division in Cookeville, TN, is on schedule with a planned completion date of April 1.

The expansion, announced in September 2020, includes the acquisition of a 500,000-sq.-ft. property purpose-built for FDA manufacturing and packaging operations and represents Aphena’s expansion into biologics, cold chain storage and third-party logistics distribution.

The company’s bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start, for solid-based products including tablets, capsules, caplets, soft gels and gel caps. Aphena plans to install 30 more high-speed lines in the new facility, bringing monthly capacity to over 80 million bottles.

Aphena’s bottling services include purchasing all of the primary and secondary packaging materials, including pharmaceutical bottle labeling with serialization support. Various configurations and sizes are available, including square bottles, and Aphena has the ability to run batches from 1,000 to 10 million bottles under cGMP quality systems.

“This new facility and bottling lines set the foundation for Aphena’s solid dose packaging future, allowing us to maintain a 50% capacity level for any new projects or surge capacity requirements so that we can continue to stay ahead of our current and future customers’ needs,” said Eric Allen, Aphena’s EVP of Sales and Marketing.

Paragon Biosciences Expands Cell and Gene Therapy Platform

Paragon Biosciences, a life science innovator that creates, invests in and builds life science companies in biopharmaceuticals, cell and gene therapy and synthetic biology utilizing artificial intelligence, has launched CiRC Biosciences, a cell therapy company developing treatments for serious diseases with high, unmet needs with an initial focus on the eye.

"The addition of CiRC Biosciences to our portfolio builds upon our cell and gene therapy platform, an area that has tremendous potential to address serious genetic diseases," said Jeff Aronin, founder, chairman and chief executive officer, Paragon Biosciences. "CiRC Biosciences gives us the science to target retinal diseases that could lead to vision restoration with numerous other applications in the years ahead."

CiRC Biosciences is currently advancing pre-clinical development of chemically induced retinal cells for vision restoration in Geographic Atrophy Age-Related Macular Degeneration (Dry AMD), which is the most common cause of irreversible vision loss over the age of 65, and advanced Retinitis Pigmentosa (RP), a genetic disorder that causes tunnel vision and eventual blindness. There are no U.S. Food & Drug Administration (FDA) approved treatments to restore vision loss in Dry AMD or RP.

The company's novel mechanism of action is designed for direct chemical conversion of fibroblasts into other cell types using a cocktail of small molecules in an 11-day chemical conversion process. Pre-clinical studies have shown efficacy in blind mice that demonstrated vision restoration. CiRC Biosciences has provisional patent applications to protect its platform.

"Our technology transforms ordinary skin cells into specialized retinal cells using a cocktail of small molecules," said Sai Chavala, M.D., co-founder and chief scientific officer, CiRC Biosciences. "This process is potentially safer, quicker, more cost effective and easier to manufacturer than using traditional stem cells. Working with Paragon Biosciences to build and advance CiRC Biosciences provides us the opportunity to efficiently progress this technology through research and development stages.”

CiRC Biosciences first reported its discovery in the highly respected scientific journal Nature (April 15, 2020). A recently published New England Journal of Medicine article (Nov. 5, 2020) discussed CiRC's technology of using chemically induced cells to restore retinal function. The article concluded, "The new and emerging strategies for the rescue, regeneration, and replacement of photoreceptors suggest a bright future in the fight to preserve and restore vision in blinding eye diseases."

TCG Lifesciences Expands Footprint to the U.S.

Establishes CDMO subsidiary TCG GreenChem in New Jersey and Virginia.

TCG Lifesciences Pvt. Ltd., a company controlled by New York-based The Chatterjee Group, has expanded its operations in the U.S. with the establishment of TCG GreenChem Inc., a subsidiary of TCG Lifesciences to provide contract development and manufacturing organization (CDMO) services to global clients. TCG GreenChem offers CMC development services including process research and development and delivery of cGMP APIs. It aims at utilizing its deep expertise in areas of automated catalysis/reaction screening, reaction optimization, and continuous chemistry to support the needs of the big pharma and biotech industry. It has a robust pipeline of projects with its customers to manage their entire portfolios, offering integrated CMC and supply of APIs from early clinical trials to commercialization.

TCG GreenChem is developing novel, efficient and low-cost processes for selected COVID-19 virus related medicines and other antiviral drugs using new technologies and process schemes under contract with research foundations/hospitals, U.S. Government, and selected biotech companies. It is also engaged with developing several selected drugs with backward integration all the way to the starting materials within U.S. shores. TCG GreenChem operates out of a 3,000 SFT lab space in Richmond, Virginia's VCU's Biotechnology Research Park with access to state-of-the-art facilities. It also occupies 54,000 SFT lab/office space in New Jersey in the Princeton South Corporate Center, a one-of-a-kind process research and development facility including cGMP capabilities.

"The priority of our customers today is to find ways to leverage their external partners to fill up a large part of their product development needs,” said Swapan Bhattacharya, managing director, TCG Lifesciences Pvt. Ltd. “In order to become their preferred partners, we need to provide high quality, efficient and low-cost services which are only possible if we deploy high-end talents and skills that can drive innovation. TCG GreenChem has an exceptional management team, technological expertise and know-how, which is critical for the development of architecturally complex intermediates and APIs by utilizing state-of-the-art synthetic organic chemistry."

Chris Senanayake, CEO and CSO, TCG GreenChem, said, "We are excited to be a part of TCG Lifesciences Pvt. Ltd., as they are highly valued by their pharmaceutical partners and have a reputation of embracing innovation and high-end technology which are the cornerstones of the TCG GreenChem's strategy. Our mission is to create a ‘technology innovator’ CDMO, to partner with the pharmaceutical, biotechnology, and generic industries in delivering integrated, accelerated, and economical services utilizing green sustainable technologies with a global footprint. Leveraging our knowledge of drug development and commercialization, we want to be the Drug Development Engine ‘Accelerating Molecules to Medicines’ by advancing preclinical candidates into phase I and beyond, for our clients and partners."

Maravai LifeSciences Expands CDMO Capabilities at TriLink

Maravai LifeSciences, a global provider of life science reagents and services, is expanding its contract development and manufacturing organization capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in 1Q21 and will increase TriLink's small molecule manufacturing capacity for additional scale-up of CleanCap, its messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. The company is also currently completing the construction of its plasmid DNA production facility.

Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity with five cGMP suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.

The expansion positions TriLink to meet global demand for research- and GMP-grade CleanCap capping reagent, nucleoside triphosphates (NTPs) and development and cGMP services for mRNA therapeutics and vaccine production. The increase in demand for these critical raw materials and APIs is being driven by COVID-19 vaccine development as well as the rapid growth in investigational mRNA therapeutics and advancements in gene editing and cell therapy such as CRISPR, base editors and CAR-T therapies.

CleanCap is a co-transcriptional 5' capping technology that generates a natural Cap 1 structure with higher mRNA capping efficiencies. CleanCap is designed to increase mRNA yields during transcription, simplify and shorten the mRNA manufacturing process resulting in higher levels of protein production. TriLink has developed a suite of CleanCap analogs that are tailormade for therapeutics and vaccines.

TriLink recently entered a collaboration with Imperial College London (ICL) to manufacture saRNA for ICL's COVID-19 vaccine project.

Baxter BioPharma Solutions to Expand Sterile Fill/Finish Manufacturing Site

Baxter International Inc., a global leader in sterile medication production and delivery, announced a $50 million expansion of its sterile fill/finish manufacturing facilities located in Bloomington, Ind. These facilities are operated by Baxter’s BioPharma Solutions business, a premier contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals. The expansion is being funded by a combination of Baxter and client investment. Additional details of the agreement were not disclosed.

The planned expansion of existing facility infrastructure includes construction of a new 25,000 square foot warehouse; a new filling line for flexible plastic containers; a high-speed automated syringe fill line capable of filling up to 600 units per minute and a new high-speed automated visual inspection line. Construction is currently underway and is expected to be completed in 2021. Contract product manufacturing in the expanded facilities is expected to begin in 2022. The new facilities will support programs that are expected to add approximately 100 new jobs at the site, in addition to jobs created due to construction.

“We pride ourselves on being a contract manufacturing partner with the specialized expertise, proven experience, and facilities to help our clients successfully achieve their sterile manufacturing objectives,” said Marie Keeley, vice president, BioPharma Solutions. “Our Bloomington facility is already a global leader in sterile contract manufacturing, and this expansion will add capacity and state-of-the-art technology that will better enable us to meet the diverse needs of our clients and the patients they serve.”

The Bloomington site currently manufactures life-saving products for approximately 25 pharmaceutical and biotechnology companies. The site has capabilities and expertise in parenteral delivery systems and clinical and commercial vaccine manufacturing, including preventive and seasonal vaccines for global markets. In addition, Bloomington offers a range of production and commercialization services, including clinical development, formulation, packaging and commercial launch capabilities. The site is also home to the Lyophilization Center of Excellence, an industry-leading resource center focused on the development of high-quality freeze drying.

About Baxter BioPharma Solutions:

Together with its sister contract manufacturing facility in Halle (Westfalen) Germany, Baxter BioPharma Solutions offers services for prefilled syringes, liquid and lyophilized vials and cartridge filling as well as specialized capabilities for cytotoxics and biologics manufacturing. For more information on BioPharma Solutions, visit: www.BaxterBioPharmaSolutions.com.

About Baxter:

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we have been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.

Piramal Holds Grand Opening of New OSD Form Facility in Sellersville, PA

Piramal Pharma Solutions (PPS), a leading contract development and manufacturing organisation (CDMO), held a grand opening event at their recently acquired solid oral dosage drug product manufacturing facility located in Sellersville, Pennsylvania.

Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, addressed the guests remotely and explained that this acquisition broadens the offering of Piramal Pharma Solutions by adding solid oral dosage form capabilities (tablets and capsules) in North America.

He stated: “This is a big day for us. We are rapidly growing and we take pride in the fact that we let our customer’s guide how and where we grow."

"The Sellersville facility is a great example of this. It was acquired because it addresses a market need for solid oral dosage form development and manufacturing in the United States."

"It also gives us new capabilities in liquids, creams and ointments. As a leading CDMO offering end-to-end solutions across the drug lifecycle, it’s vital that we provide our customers with a complete suite of services in all major geographies.”

Robert Harvie, Vice Chair of Bucks County Commissioners, spoke to the audience and welcomed PPS to the area.

“Founded more than 350 years ago, this county has attracted people and businesses from all over the world because of its location and resources. We’re proud to still be attracting businesses such as Piramal Pharma Solutions, which provides employment and economic benefits to our residents and produces valuable medicines that can quickly get to the people who need them.”

Thomas Hufnagle, Mayor of Sellersville Borough, said: “It did my heart good to come here this morning and see the full parking lot at this site. It’s clear that this company is looking to building for the future, which makes this a great day.”

John Fowler, Chief Operating Officer, Piramal Pharma Solutions, also addressed the audience. Mr. Fowler stated: “Bringing the Sellersville site into the family significantly helps us accomplish our goal of getting medicines to patients."

"This is the thirteenth facility in our global network and our first solid dose facility in North America, giving us critical mass that matches local market need.”

Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions, added: “As a patient-centric organisation, our mission is to help our customers reduce the burden of disease on patients. It is the reason why we get up in the morning. And the Sellersville site most definitely enhances our ability to do that.”

Metrics Contract Services Begins Plant Expansion

Metrics Contract Services, a full-service global contract development and manufacturing organization (CDMO), has begun construction on the expansion of its novel oral solid dosage manufacturing facility expansion in Greenville, NC.

The $10 million investment will add 3,760 square feet of production space to the current facility, providing added flexibility and capacity to the CDMO and its clients.

The expansion consists of three new rooms: one dispensing/flex room, one tablet press room and one flex room to accommodate the company’s growing portfolio of commercial services following sustained increase in demand from clients for high potent handling capabilities.

New equipment also forms part of the investment and includes a Fette FE55 tablet press, a Bosch 720 encapsulator, which both offer containment capabilities for the safe handling of potent products, and a weigh and dispense isolator.

“The new equipment we’ve purchased is ideal for the small batch size and high changeover products which our clients require,” said John Ross, president at Mayne Pharma U.S and Metrics Contract Services. “Our clients will see immediate benefits through higher yields and improved potent handling. We recognized that customer’s commercial requirements often demanded increased flexibility within production suites. This expansion will cater for those needs because it creates more spaces where equipment trains can be tailored to the applicable process.”

The expansion project which has been in development over the last six months is expected to be complete and fully operational by February 2021.

“This is a significant investment for the business and reflects our commitment to increasing our novel oral solid manufacturing capabilities and providing our clients with quality services from initial concept through to global commercialization,” said Ross. “We are now actively looking at the next phase of investment and how to maximize the expanded facility even further with the potential addition of further packaging and adjacent formulation technologies.”

Metrics Contract Services offers quality pharmaceutical formulation development; clinical trial materials manufacturing for all phases; analytical method development and validation services and commercial scale manufacturing and specializes in highly potent, novel oral solid dosage forms.

Aphena Pharma Invests in Tennessee Expansion

Adds 258,000 sq.-ft. to current Cookeville footprint and represents expansion into biologics, cold chain storage and third-party logistics distribution.

Aphena Pharma Solutions is investing $21 million to expand its Solid Dose Division in Cookeville, TN, with the acquisition of a 500,000-sq.-ft. property, purpose-built for FDA manufacturing and packaging operations.

Aphena began renovations to transform the property into a state-of-the-art pharmaceutical packaging and distribution facility, which will also serve as Aphena’s corporate headquarters. The renovations will be completed by Feb. 1, 2021.

This acquisition, which will add 258,000 square feet to Aphena’s current Cookeville footprint, also represents the company’s expansion into biologics, cold chain storage and third-party logistics distribution.

“This new facility will make Aphena a top contender in the pharmaceutical contract service space, starting with over 12,000 pallets of cold chain storage capacity,” said Eric Allen, Aphena’s EVP of Sales. “Being able to offer turnkey packaging and distribution services for biologic products, plus expanding the current operations with newly innovated bottling and packaging lines, will continue to attract key pharmaceutical customers to the Middle Tennessee area.”

The expansion will allow Aphena to install 24 high-speed bottling lines and eight thermoform blister packaging lines. Also, 200,000-plus sq.-ft. of warehouse space provides a strong foundation for a new, third-party logistics program for current and future customers.

Aphena Pharma Solutions provides contract manufacturing and packaging services for the pharma, biopharma, consumer health and medical device markets. With two separate FDA- and DEA-registered locations in the U.S., Aphena handles solid dose, liquids, gels, creams, ointments, foams, suspensions and lotion-based products.

Thermo Fisher Scientific’s New Manufacturing Facility, Lenexa, Kansas, US

Thermo Fisher Scientific opened a new manufacturing facility in Lenexa, Kansas to meet the increasing demand for viral transport media (VTM) being used in Covid-19 testing in the US.

The new manufacturing facility was developed with an estimated investment of $40m after the US government contracted the company to provide highly specialised VTMs for COVID-19 sample collection in May 2020. Production was commenced in July 2020, while official inauguration was held in August 2020.

The facility began operations with an initial production rate of 50,000 VTM units a week. It currently manufactures more than eight million units a week and is expected to deliver more than 150 million units by the end of 2020.

The site can also be expanded to meet the requirements for the rising COVID-19 testing demand in future. The facility will subsequently focus on the new research and development activities related to COVID-19.

Thermo Fisher Scientific created 300 full-time jobs for the local community through the new manufacturing plant.

The new manufacturing facility spans an area of 120,000ft² and handles the production and quality control of VTM products for COVID-19 sample collection.

VTM are plastic tubes used for the safe collection and transportation of patient samples to laboratories for virus detection.

The units help make sure that the sample collected from a COVID-19 nose swab retains viability while being transported to the laboratory for testing. VTM are manufactured and dispensed into tubes in an aseptic condition to maintain the accuracy of COVID-19 test results.

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

Lonza’s cell and gene therapy manufacturing facility in Portsmouth, NH was designed with a strong focus on automation.

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland.

However, the firms plan to establish additional production suites across Lonza’s worldwide facilities. The aim is to make up to one billion doses of mRNA-1273 per year, assuming a dose of 50 µg.

Preliminary manufacturing work has begun in the United States, according to Lonza spokeswoman, Sanna Fowler.

“In July we started small-scale production at our Portsmouth, NH, site and are on track for the delivery of four suites for large-scale manufacturing. One of these will be in Portsmouth with a further three in our Ibex facility in Visp, Switzerland,” she says.

Moderna moved mRNA-1273 into Phase III trials in July. The NIH and the Biomedical Advanced Research and Development Authority (BARDA) are providing support as part of Operation Warp Speed.

Moderna’s mRNA vaccines comprise noncoding regions and variable sequences encoding the desired antigen. The firm says its candidates are faster to make than mAbs made from components produced in cells.

Another advantage—according to Moderna—is that mRNA synthesis is straightforward to automate.

Fowler tells GEN, Lonza will use synthesis processes developed by Moderna to scale up production of mRNA-1273.

“Lonza will be replicating Moderna’s core process design and scaling up to enable them to meet their goal of global supply,” notes Fowler. “This includes harnessing digital technology to ensure repetitive automated processing, paperless generation, review, and exchange of data.”

Demand for automation, digital manufacturing, and “bioprocess 4.0” ideas are increasing across the industry, continues Fowler.

“This is clearly a huge area and these technologies are becoming an integral part of all biomanufacturing processes. For example, our new 6,000 L facility in Portsmouth, NH, has been built with a strong focus on automation,” she says.

“We are implementing full-suite process analytic technology (PAT) and advanced multi-variate analysis (MVA) to ensure consistent performance.”

There are also clear benefits for CDMOs, Fowler says, explaining, “Having access to data not only enables us to improve efficiency but can also facilitate the regulatory approvals and gives our customers full visibility.”

Lonza is part of a cross-industry group led by Biophorum (BPOG) that aims to help drive “Bioprocess 4.0” forward. The firm contributed to the recently published manifesto on the quality control laboratory of the future.

Lonza Works with Humanigen on COVID-19 Drug Candidate

Swiss contract drug maker Lonza struck a deal with California-based biopharmaceutical company Humanigen to expand manufacturing capacity for Humanigen’s lenzilumab, a drug candidate in late-stage clinical trials for COVID-19.

Lenzilumab is in phase III clinical trials to determine whether the drug can prevent and treat an immune hyper-response in COVID-19 patients called “cytokine storm”, the companies said in a statement.

The collaboration with Lonza will provide Humanigen with additional production capacity for lenzilumab at Lonza’s facilities at Hayward, California, with operations intended to start in 2021, the companies said.

Lonza is also working with Moderna to make its COVID-19 vaccine candidate and with China’s Junshi Biosciences to help produce a neutralizing antibody against COVID-19.

Civica Rx Lays Out Sterile Injectables Plant

Generics maker Civica Rx is building out a sterile injectables manufacturing plant in Petersburg, Virginia, pegged to shore up supplies of essential meds for COVID-19 treatment and more.

Last spring, upstart generics maker Civica Rx joined forces with the brand-new Phlow Corp. in a push to “onshore” U.S. drug manufacturing and supply essential meds to hospitals fighting the pandemic. Now, the company is blueprinting a dedicated plant to do just that.

Civica is laying out $124.5 million to build a sterile injectable manufacturing facility in Petersburg, Virginia—part of its team-up with the once obscure Phlow, which rose to prominence last year on the back of a massive government contract to produce COVID-19-related drugs.

Construction has already started on the 120,000-square-foot plant, to come online within the next three years, Civica said (PDF). The facility will ultimately crank out 90 million vials and 50 million prefilled syringes per year, focusing on drugs for COVID-19 patients as well as meds used in emergency rooms, intensive care units and surgeries.

The plant will come equipped with disposable technology and advanced filling lines, plus temperature-controlled warehousing for raw materials and finished drugs. It will be kitted out to perform steam sterilization, plus automated packaging and visual inspection and is “built to accommodate future growth.”

A leadership team is already in place, with more hiring set to begin this quarter, Civica said. The facility will ultimately employ some 180 workers.

Civica—a generics maker formed in 2018 to combat drug shortages and the price spikes that ensue—has long been gunning for a U.S. manufacturing operation of its own, with the Petersburg plant “a dream come true” for the company, CEO Martin VanTrieste said in a release.

It also marks Civica’s role in a broader partnership with Phlow, enlisted early last year in the Trump administration’s push to boost drug manufacturing stateside.

Phlow in May signed a $354 million contract with the Biomedical Advanced Research and Development authority (BARDA) to build a generic medicine and active pharmaceutical ingredient (API) factory in Richmond, Virginia. That deal—one of the largest BARDA’s ever awarded—can be expanded up to 10 years for a total of $812 million. Civica’s task is to churn out finished drugs in vials and syringes for its own member hospitals as well as the U.S. Strategic National Stockpile.

Phlow’s notoriety bump, which drew a fair amount of heat last spring—the company’s CEO, Eric Edwards, previously ran the show at Kaléo, infamous for hiking the price of an EpiPen competitor 700%—followed a chat between Edwards and Civica chief VanTrieste more than a year earlier. The two had struck up a conversation to discuss generic drug manufacturing, VanTrieste told Fierce Pharma at the time of the loan announcement.

Edwards “wanted to know if I would teach him the Civica model,” he said. “So we brought him in to shadow us, and he started learning about the over-reliance in the pharmaceutical supply chain on foreign suppliers.”

Phlow was one of several companies tapped in the “onshoring” manufacturing push last year, fueled by a pandemic that put the nation’s dependence on overseas APIs into sharp focus. In May, the U.S. International Development Finance Corporation unveiled a $765 million loan to support camera maker Kodak’s plunge into the generic drug making game.

Questionable stock moves that led to an investigation by House Democrats and the Securities and Exchange Commission put Kodak’s plans on the rocks, though the company in September cleared itself of wrongdoing. CEO Jim Continenza later defended his company’s handling of the loan plans and reiterated Kodak’s intention to break into API making—with or without government support.

Thermo Fisher Plans Carlsbad Plasmid DNA Plant

Thermo Fisher sketched out a new plasmid DNA plant in Carlsbad, California, set to boost its clinical and commercial offerings for cell and gene therapies.

Thermo Fisher Scientific is shoring up production of cell and gene therapies on both sides of the pond, a move it hopes will support the development of COVID-19 drugs and vaccines—and ensure supplies are in place should they pass muster with regulators.

The New Jersey contract manufacturer is laying out a new plasmid DNA manufacturing facility at its Carlsbad, California, campus, aiming to boost its cell and gene therapy offerings against the backdrop of a global plasmid market where demand has quickly outpaced supply, the company said.

That is on top of plans for a new cryocenter in Germany. That site, one of two new German facilities set to come online in the next few weeks, will offer cold chain support for clinical trials of cell and gene therapies, including COVID-19 vaccine hopefuls, in Europe and beyond.

The 67,000-square-foot Carlsbad facility will add some 150 jobs over the next 12 months, with construction pegged to wrap in the first half of 2021, Thermo Fisher said. The site will boost clinical and commercial output of plasmid DNA used to develop and produce cell and gene therapies for cancer, as well as mRNA vaccines. It will also be equipped to churn out large-scale plasmid DNA as a primary drug substance for DNA therapies, the company said.

The facility will be kitted out with single-use equipment capable of handling projects up to 1,000 liters and will boast digital connectivity and data visibility to smooth operations and make training employees easier.

Thermo Fisher is no stranger to the field, with a cell and gene therapy footprint in Massachusetts and Florida, plus a newly minted cell therapy manufacturing plant in Princeton, New Jersey—but it figures the expanded commercial and supply chain services at its Carlsbad site will smooth the wrinkles in the current plasmid market.

"The race to develop new transformative cell and gene therapies and vaccines is outpacing supply of commercial-quality plasmid DNA that can be produced at scale," Mike Shafer, SVP and president of pharma services at Thermo Fisher, said in a release.

"Our new state-of-the art site will not only tackle the supply bottleneck for our customers but also uniquely positions us to deliver robust, end-to-end cell and gene therapy capabilities.”

A day before Thermo Fisher sketched out its Carlsbad plans, the company announced a twin pharma services expansion in Europe. First up for completion in late December is an 86,000-square-foot packaging, storage, logistics and distribution center in Rheinfelden, Germany, which will serve as a strategic logistics hub for European clinical trials.

Then there’s Thermo Fisher’s 9,600-square-foot cryocenter in Weil am Rhein, Germany, set to go live in January 2021. That site, poised to support super-cold storage of experimental cell and gene therapies, including vaccines, will boast minus 112 degrees Fahrenheit freezers, liquid nitrogen storage tanks and walk-in storage as cold as minus 4 degrees Fahrenheit.

Aside from supporting trials of cell and gene therapies against COVID-19, Thermo Fisher in September teamed up with Humanigen to help the California biotech scale up production of its clinical-stage cytokine storm hopeful, lenlizumab. That deal marked Humanigen’s third tie-up for its monoclonal antibody on the heels of manufacturing pacts with Lonza and Catalent.

Elsewhere, Thermo Fisher in October drew up plans for a new, $130 million Singapore facility that will house two sterile filling lines, expected to eventually crank out 30 million drug and vaccine doses per month, the CDMO said.

Merck’s ADC Manufacturing Facility Expansion, Madison, Wisconsin, USA

Merck announced the expansion of its high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) production capabilities and capacity at its facility in Madison, Wisconsin, US, in September 2020.

With an estimated investment of $69m (€59m), the expansion will facilitate large-scale production of increasingly potent compounds for potential cancer treatment.

The Madison facility expansion will create approximately 50 full-time jobs beginning in 2021, expected for completion by mid-2022.

Merck will add a new 6,500m² (70,000ft²) commercial building dedicated to the HPAPI manufacturing facilities in its established Madison campus.

The new building will feature one of the largest single-digit nanogram containment production facilities for the manufacturing of HPAPIs. It will handle nanogram-single-digit occupational exposure limit materials, allowing for a continuous flow of ADCs production.

Madison facility, the first commercial facility in the US dedicated to the development of ADC, handles highly active materials.

The addition of the new building will expand the company’s ADC manufacturing capabilities together with the existing campus in St Louis, Missouri, US, that specializes in ADC bio-conjugation, APIs, excipient and adjuvants manufacturing.

ADCs are a new group of medications designed as a targeted therapy for cancer treatment, developed by linking a cytotoxic anticancer drug payload to a highly specific antibody via a biodegradable linker.

Fujifilm Continues CMDO Expansion Spree with New Boston Site

Fujifilm is on a manufacturing tear, announcing a third boost to its U.S. CDMO footprint in just two weeks.

That did not take long. Fujifilm is laying plans for a new manufacturing facility in Watertown, Massachusetts—the second it is announced in a little over a week.

Fujifilm and The Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM) have ginned up $76 million in funding and signed a lease for a 40,000-square-foot site at The Arsenal on the Charles business park in Watertown. Set to kick off operations in early 2022, the manufacturing-and-innovation-center-in-waiting will support research and development in cell and gene therapy, gene editing, immunotherapy and biotechnology, Fujifilm said.

Fujifilm's latest U.S. move is just part of the Japan-based company's push toward $1.8 billion in CDMO revenues by 2024, a goal sketched out during a presentation at the annual J.P. Morgan healthcare conference. The biggest piece of that puzzle is a $2 billion megaplant planned for a site in the U.S.

The CABIM-partnered facility in Watertown, which will open with 40 full-time staffers, is expected to house eight clean rooms for production of cell and viral vector products, as well as quality control, lab, office and conference space. Fujifilm Diosynth, the Japanese company’s bio CDMO arm, will carry out process development and manufacturing work at the plant.

Working with CABIM, an R&D consortium that Fujifilm had a hand in establishing, the company aims to tap into the Greater Boston Area’s bustling life sciences ecosystem, with a view to training up emerging manufacturing talent.

“Fujifilm is pleased to partner with leading academia, industry, and teaching hospitals, to explore the application of genetically modified cell therapies, and bring new treatment options to the market,” Takatoshi Ishikawa, senior EVP and chief life science officer at Fujifilm, said in a release.

CABIM has a slate of collaborators lined up, including Brigham and Women’s Hospital, Dana-Farber Cancer Institute and the MilliporeSigma unit of Germany’s Merck KGaA. The consortium uncloaked in 2019 and is backed by equal investments from Fujifilm, Harvard University, Massachusetts Institute of Technology, Cytiva and Alexandria Real Estate Equities.

The new site should not be confused with a $40 million viral vector plant that Fujifilm sketched out on Jan. 5. That facility, also in Watertown, was set to become the company’s third viral-vector manufacturing site; the latest plant will make four. The first Watertown facility will start process development this fall, Fujifilm said.

Meanwhile, Fujifilm is also plowing an eye-popping $2 billion into a large cell culture production site in the U.S., which will boast eight 20,000-liter bioreactors and have the potential for 24 more. Fujifilm Diosynth will operate the facility, which will be built out of an existing location in the U.S. The company will offer drug substance manufacturing and fill-finish services, as well as packaging and labeling, and expects the site to be up and running in the spring of 2025.

Fujifilm is on a mission to hit ¥1 trillion in healthcare revenue by the middle of the decade, COO Kenji Sukeno said during his JPM presentation this week. To get there, it is largely banking on sales growth from its fast-growing medical systems and CDMO business, Sukeno said.

The company is gunning for ¥500 billion ($4.6 billion) in medical systems sales in 2021, which hinges on the close of Fujifilm’s $1.7 billion buyout of Hitachi’s diagnostic imaging-related business. Meanwhile, Fujifilm hopes to grow CDMO revenue to ¥200 billion ($1.8 billion) by 2024—and the company’s cash infusion spree will help it meet that goal, Sukeno said.

Cognate Increases Cell, Gene Therapy Manufacturing with New Plants

CDMO Cognate BioServices started work on a new commercial manufacturing plant that will nearly double capacity at its current headquarters in Memphis, Tennessee.

With the demand for cell and gene therapies mounting, CDMO Cognate BioServices is looking to swiftly expand its U.S. headquarters with two new facilities—and it is not stopping there. Its dedicated gene therapy unit, Cobra Biologics, is plotting its own scale-ups in Europe.

Stateside, Cognate is building out its global manufacturing facility and headquarters in Memphis, Tennessee, to the tune of 250,000 square feet of space and 500 new jobs, which will be added over the next four years, a spokesperson said via email.

A new commercial manufacturing plant at the site will focus on cellular and advanced therapies. The upgrades, which also include a new distribution center, will nearly double capacity at the CDMO’s home base, Cognate said.

The company has kicked off construction of the 170,000-square-foot manufacturing facility, aiming to get it up and running “as quickly as possible,” the spokesperson said. The new 80,000-square-foot distribution center should be open for business "in the coming weeks."

The expansion will add more than 500 jobs in Memphis over the next four years, the spokesperson said. The company declined to say how much money it is investing in the new facilities.

Across the pond, Cobra Biologics, Cognate’s gene therapy unit, is embarking on a multiphase upgrade of its plasmid DNA services. The company will add new clinical and commercial DNA facilities at its existing European operations in Sweden and the U.K., teeing up a fourfold jump in high-quality DNA manufacturing, Cobra said.

Cognate picked up Cobra in early 2020. The CDMO currently operates two European plants: a DNA, microbiota and fill-finish plant in Matfors, Sweden; and its Centre of Excellence for Advanced Therapies in Keele, England, which focuses on DNA and viral vector production, according to the company’s website.

As for when Cobra’s expansions may come online, it is complicated, the spokesperson said.

“These are complex builds that require coordination of different groups and ultimately regulatory agencies," he said. "So, some of them will come online this year, and others are planned to come online at different times within the next 12-36 months.”

“We are planning the capacity to match the demand in the industry and can speed up some of these if needed, and as needed by our clients,” he added.

REST OF WORLD

JSR Life Sciences Expands European Footprint

Will co-locate primary European operations for affiliate companies KBI Biopharma and Selexis SA in Geneva’s ZIPLO campus.

JSR Life Sciences, LLC is increasing its European footprint with a newly expanded, state-of-the-art facility that will co-locate primary European operations for its affiliate companies KBI Biopharma and Selexis SA. The two companies will occupy 93,612 sq. ft. (8,700 square meters) in Geneva’s ZIPLO (Industrial Zone Plan-les-Ouates) campus. KBI Biopharma’s expanded facility will enable the company to offer clinical cGMP biologics bulk drug substance manufacturing for European clients. Selexis’ new workspaces will allow the company to meet the increasing demand for its highly specialized mammalian cell line development technologies and services. Together, the companies anticipate creating more than 250 new highly technical jobs in the new facilities.

KBI Biopharma’s new 60,256 sq. ft. (5,600-square-meter) biologic bulk drug substance manufacturing facility is scheduled to be operational by mid-2022 and will create more than 200 technical positions in development, operations, and quality assurance. From this facility, KBI will supply customers with cGMP bulk drug substance to meet their clinical trial requirements. The expanded capabilities include two 2,000L single-use cGMP manufacturing trains with process development and analytical testing labs on site. cGMP quality control testing for release and in-process testing will be performed on-site in the new Geneva facility, while cGMP testing of drug substance and drug product stability will remain at the KBI Biopharma BVBA labs in Leuven, Belgium.

Selexis’ Geneva footprint will increase by 200% and is scheduled to be operational by mid-2021. The new space will include laboratory, office, health/wellness, and employee common spaces. Throughout the expansion, Selexis has invested in a Minergie-certified building (a Swiss building standard aimed at construction with above-average demands on quality, comfort, and energy).

Floor plans support the unique technical needs of Selexis cell line workflows, including department-wide segregation and monitoring systems. In addition to new standard cell line development suites, the new facility will also include two separate cell culture suites to accommodate quarantined client-specific cell lines or client-dedicated cell line spaces.

New Shenzhen Children’s Hospital Will Be Covered in Sky Gardens

B+H Architects, in a joint venture with East China Architectural Design & Research Institute (ECADI), has been selected as the winner of the competition to design the new Shenzhen Children’s Hospital and Science and Education Building. The building’s design will emphasize the collaboration between research, education, and patient care spaces.

The new hospital will be built to the west of the existing Shenzhen Children’s Hospital campus. It will take design cues from the surrounding mountains and adopt a gently terracing approach with the upper floors stepping back to allow the building to be covered in multiple sky gardens. A vertical “secret garden” will also be included to provide a distraction to patients and their families.

"Our vision is to ensure that the building’s occupants not only fully engage with the surrounding natural landscape, but that we create a unique micro-landscape within and around the building, from ground floor to rooftop gardens,” said Stephanie Costelloe, Principal and Director of Healthcare, Asia, in a release.

An “urban living room” on the ground floor will connect the hospital to the surrounding community and host a wide array of public spaces and activities for patients, visitors, and those just passing through. A colorful graphic of leaves will cover the canopy above, creating an aesthetic connection with the nearby park.

A cluster of social and interaction spaces for staff are provided at the northeast corner, creating a “social window” that connects to the park. Research is placed on the same floors as inpatient wards to provide proximity to patients with a “lab to bedside” approach while prioritizing collaboration between clinical staff, researchers, and students. A “collaboration zone” is located at the junction of the ward and research zones that will house formal and informal education and social spaces for the staff. Additionally, staff living spaces will be included on the upper floors.

Roche New Global Operations Hub

Damian Siggins, Roche's global head of pharma technical transformation and site head, announces plans for a new Mississauga global operations hub.

After watching its rheumatoid arthritis med Actemra go up on in flames in COIVD-19 trials, Swiss drugmaker Roche opted to sign an August antibody manufacturing pact with Regeneron. Now, seeking to get its manufacturing house in order, Roche is splashing the pot on a new global operations hub in Canada.

Roche will dole out $500 million over five years for a global technical operations center at its Canadian pharma headquarters in Mississauga, Ontario, the drugmaker said.

The hub will aim to hire 200 workers by the end of 2020 in supply chain, quality and other regulatory functions, Roche said. The facility will then add 300 more workers by 2023.

Roche's addition at its existing Mississauga site will not manufacture drugs itself, but will support operations and supply across the drugmaker's 13 plants and 11 sites around the world, a Roche spokeswoman said. The Mississauga campus now houses Roche's Canadian commercial unit as well as product development, global procurement and pharma informatics, the company said.

Most recently, Roche joined a major pact with New York's Regeneron to help produce and commercialize a COVID-19 antibody cocktail, dubbed REGN-COV2, that is currently under FDA review for an emergency use authorization in moderate-to-severe patients.

Under a seven-year licensing deal, Regeneron and Roche will each reserve manufacturing capacity for the therapy in preparation for future regulatory approvals, with Regeneron handling the U.S. rollout and Roche taking on distribution elsewhere.

Roche will set aside up to 100,000 liters of bioreactor capacity to meet its end of the agreement with Regeneron roping off 40,000 liters, according to a securities filing. The deal allows for more space to be set aside in case of future need.

The partners expect to churn out 650,000 to 2 million treatment doses, or 4 million to 8 million preventive doses, of the cocktail each year, Regeneron said. Final dosages are still being worked out in clinical trials and could change those figures.

Manufacturing capacity is a major challenge for COVID-19 antibodies, which are typically expensive and time-intensive to produce. Earlier this month, former FDA Scott Gottlieb forecast the industry would need to produce between 300,000 and 400,000 doses of antibody therapies each month to meet potential demand and said the industry was "too late" on scaling up to hit orders this year.

Roche's latest into the hunt for a COVID-19 therapy could prove profitable for the drugmaker in the short term.

The cocktail could see sales as high as $6 billion in 2021, according to Morningstar analyst Karen Andersen—and that with only a 60% chance of approval this year from her team. If the drug gets a speedy FDA approval, a possibility given the current political environment and REGN-COV2's role in President Donald J. Trump's COVID-19 treatment, the drug could even hit $10 billion in 2021, Andersen said.

Roche's big logistics play comes after years of downsizing global manufacturing operations, including cutting hundreds of jobs.

In September 2019, Roche announced plans to lay off 132 workers at its Clarecastle, Ireland site with a €24 million set-aside for the exiting employees. Earlier in the year, the drugmaker pledged to close its production plant in Rio de Janeiro over four to five years, endangering the positions of 440 Roche employees and 200 contractors onsite, where it makes drugs for the local market and Europe.

Samsung Biologics’ P4 Super Plant, Songdo

Samsung Biologics is planning to expand its manufacturing facilities with the construction of its fourth biopharmaceutical manufacturing plant, P4-Super Plant, in Songdo, South Korea.

The plant is a part of the company’s long-term strategy to improve its operational efficiency and to scale up its development and production capabilities in wake of rising biomanufacturing demands.

Additionally, Samsung Biologics launched a new cell line technology to boost its cell culture services in August 2020. The company is also in talks with the Incheon Free Economic Zone (IFEZ) authorities to acquire additional land for the development of its second bio complex.

Both facilities could cost more than KRW2tn (approximately $2bn), which will be more than the company’s combined investment in its existing three plants in the last nine years.

The manufacturing activities in P4-Super Plant should begin in the second half of 2022.

P4 Super biologic plant will be located at the company’s existing site in the Songdo district of Incheon in South Korea. The total floor area of the Super Plant will be 2,560,880 sq. ft. (238,000m2), which is equivalent to the combined floor area of the existing three plants.

With the area of approximately 3,550,800 sq. ft. (330,000m2), the proposed land for the second bio complex lies close to the existing complex of the company.

The land will be utilized to create an Open Innovation center to nurture biotech companies and develop a global R&D facility while accommodating the company’s potential future plants.

Vetter Invests in Ravensburg Headquarters

The company is repurposing existing buildings while expanding sites.

Vetter has moved into its new headquarters in Ravensburg, Germany. The opening of the building, known as Ravensburg Vetter Kammerbruehl, sends a clear signal from the family-owned company: “stability and progress will continue – even during globally difficult times”.

While the situation regarding the coronavirus continues to shift, Vetter says it is doing what is necessary to continue being a stable and reliable partner for its customers and suppliers. As a CDMO, the company works together with its clients to continue enabling the supply of oftentimes life-saving drugs to patients worldwide.

With the move to the new headquarters, Vetter is responding to the continuous growth of headcount and changing circumstances. “We are relying on sustainable and future-oriented activities with the focus on our customers and their patients,” says MD Peter Soelkner.

The building is designed for around 1,000 employees. In addition to an appropriate level of office space, it includes a company restaurant, a cafeteria and about 40 conference rooms. Vetter has invested roughly $59m in a building that conforms to construction and environmental standards.

The former headquarters, Ravensburg Vetter Verwaltung, was modified to be used as a training center to house the Vetter Academy, offering employees qualification programs and individual development opportunities on a continuous basis. In addition, a separate floor in the building is now used as an audit and conference location.

Recently, a combination building for manual visual inspection and secondary packaging started operations at the Ravensburg Vetter Sued / Vetter secondary packaging site. Furthermore, an additional cleanroom for the manufacturing of prefilled syringes is planned to go operational at the Schuetzenstrasse site in 2021. At this location, Vetter has also secured an adjoining plot of land for a further production building.

Meanwhile, the recently purchased clinical manufacturing site in Rankweil, Austria, is aimed to be ready for drug development in H2 2021.

“Part of our 360-degree approach includes investments in the expansion of our development capacities,” said Soelkner. “We have observed a steady increase in demand from our customers as well as ever-more complex requirements for modern compounds.” The company has responded to these needs at both its Schuetzenstrasse site as well as at the company’s dedicated US clinical manufacturing site. “Our goal is to expand our production capacities sustainably and to align the upstream and downstream areas accordingly,” said MD Thomas Otto.

In the coming years, the company also intends to further expand on its quality control resources. Following the recent implementation of another machine for automated visual inspection, the CDMO is planning to purchase three additional units for its center for visual inspection and logistics. “We want to provide sufficient resources for the important step of final quality control and, at the same time, create greater flexibility,” said Otto. “These actions will even better enable us to offer our customers either manual or automatic visual inspection depending on individual batch sizes and special characteristics of their products.”

The company is planning further future investments as part of its long-term customer partnerships, aiming to continue its sustainable corporate development.

PPD to Open Multipurpose Clinical Research Lab in Suzhou

Will offer bioanalytical, biomarker and vaccine services for global and China-based biopharma customers.

PPD, Inc. is opening a new lab in Suzhou, China, to support China-based biopharma companies and Western pharmaceutical companies managing research studies in China. The 67,000-sq.-ft. facility is expected to be fully operational in 2021, offering bioanalytical, biomarker and vaccine services to support trials across all phases of pharmaceutical development. The company anticipates adding approximately 350 positions as a result of the expansion.

The bioanalytical lab offering in Suzhou will include services for small molecules, biologics, and cell and gene therapies. The lab will encompass multiple technology platforms across a wide range of applications, including ligand-binding immunochemistry, liquid chromatography tandem mass spectrometry (LC-MS/MS), polymerase chain reaction (PCR) and flow cytometry. The lab will specialize in the development and validation of fully compliant robust custom assays for pharmacokinetic/pharmacodynamic (PK/PD) analyses and immunogenicity assessments in both preclinical and clinical studies.

The biomarker lab offering will include services across regulatory compliance environments and fit-for-purpose situations. Analysis will be performed with molecular genomics, flow cytometry, ligand binding and LC-MS/MS to support both preclinical and clinical studies. Through PPD’s alliance with NeoGenomics Labs enhanced immunohistochemistry and molecular test menus will be offered. NeoGenomics operates an oncology-focused clinical trials testing lab in the same building as the PPD Laboratories’ central lab in Singapore and plans to establish a similar arrangement in PPD’s new Suzhou facility.

The vaccine sciences lab will provide a full range of testing services specifically designed for vaccine development trials. The lab will employ immunoassays, cell-based assays and multiplexed functional assays for vaccine efficacy and molecular assays for infectious disease monitoring. The lab’s services will span technology assessment and method development to immunogenicity and concomitant studies.

Recipharm Invests in Kaysersberg Facility

The Kaysersberg facility specializes in producing sterile liquids for therapeutic areas including eye care and ear drops.

Recipharm is investing €2.6 million in additional manufacturing capacity to support increased demand at its sterile manufacturing facility in Kaysersberg, France. The Kaysersberg facility specializes in producing sterile liquids for therapeutic areas including eye care and ear drops.

Part of the company’s phased expansion plan for the facility, this investment will add additional capacity and capabilities for the company’s customers, as well as future business.

Yves Buelens, General Manager at the Kaysersberg facility, said: “It’s great to see more investment into our facility. Our sustained growth over the last few years is testament to our talented and passionate team. We continue to look for new ways to develop our offering and implement our continued growth plan, which will naturally bring more employment opportunities to the region.”

Cambrex Completes Edinburgh Facility Expansion

The site currently has 50 employees, and the expansion will add additional laboratory space to enable the recruitment of up to 40 more scientists.

Cambrex has announced the completion of an expansion of its solid form screening and crystallization process development facility in Edinburgh, Scotland. This major expansion project has seen the facility's total footprint doubled to 15,000 sq.ft., with existing laboratory space having been refurbished, and an additional 3,500 sq.ft. of laboratory space added.

“We have seen an increase in demand for services, and specifically for larger-scale crystallization projects, so this expansion increases our efficiency and ability to respond to these requests,” commented Tom Loewald, Chief Executive Officer of Cambrex. He added, “The work we carry out at the Edinburgh site is one part of Cambrex’s integrated drug substance offering, and the investment increases our flexibility to work on projects at all stages of drug development.”

Cambrex’s Edinburgh site provides solid form development services for drug substance and drug product. These include solid state investigations such as salt, co-crystal, and polymorph screening, in addition to crystallization process development and GMP analytical services. The scientists at the site work on projects both as a standalone service to a range of pharmaceutical innovators, as well as liaising with other Cambrex sites to offer an integrated process development service.

The expansion has added an additional 13 fume cupboards to the laboratory, including three that are ‘walk-in’, which will allow the Edinburgh team to increase capacity and provide its clients with larger process crystallization development, up to 20-liter scale.

Cellgenix Completes Second Phase Facility Expansion

CellGenix, Freiburg, Germany, has completed the second phase of its facility expansion. The expansion involved reconstructing its production facility for cytokines and implementing an automated filling and freeze-drying line.

By implementing the automated filling and freeze-drying line and increasing bulkware production footprint, finished product capacity for cytokines is substantially increased.

This will enable CellGenix to meet demand for critical raw and ancillary materials as more customers reach late-stage clinical development and commercialization of their cell and gene therapies. Scaling up from phase I or II clinical trials to large-scale commercial manufacturing, the demand for GMP cytokines often rises by several magnitudes.

Consequently, a secure supply chain is imperative. A delay in delivery or change in product quality could lead to delays in production, not only increasing costs but also putting precious patient samples in jeopardy.

The expanded facility enables CellGenix to streamline its production processes. The automated filling, stoppering and capping system (operates under an Open Restricted Area Barrier System (ORABS) and) is compliant with EU GMP Annex 1 for the manufacture of sterile medicinal products, also taking into account the version which is currently under revision.

During the first expansion phase in 2018, CellGenix added additional space and personnel in its quality control, R&D, logistics and warehouse departments.

“The expansion of our facility is a result of the robust, sustainable, and profitable growth, generated by long standing and trustful customer relationships we achieved over many years. CellGenix is now well prepared for the future growth of the cell and gene therapy market. It supports our goal to further establish CellGenix as a key provider in the fight against disease, preferred supplier or raw and ancillary materials and trusted partner for large scale manufacturing of cell and gene therapies.” said Felicia Rosenthal, Chief Executive Officer at CellGenix.

NextPharma Expands OSD Capacity

Invests €15 million to increase oral solid dosage form manufacturing and packaging capacity at its Goettingen site.

As part of NextPharma’s ongoing strategy to continue to invest in its existing sites, in order to both increase capacity and to improve efficiency with modern state-of-the-art equipment, the European contract development and manufacturing organization (CDMO) recently completed a €15 million investment at its Goettingen, Germany site. The investment project, which was completed within 12 months, expands NextPharma’s existing capacity in manufacturing and packaging of oral solid dosage forms.

The project involved construction of a new 10,760 sq. ft. (1,000 square meter) building on two levels, with additional production facilities on the ground floor for mixing, compression, film coating and granulation. The investment has increased capacity at the site by 25%, equivalent to an increase in manufacturing and packaging capacity of approximately one billion tablets.

A high-performance packaging line for blister packs has been installed on the upper floor of the building, and another bottle packaging line will be added in the second quarter of 2021. The entire building is controlled with the most up-to-date building control and ventilation (HVAC) technology. The building and its facilities became operational in the third quarter of 2020.

“We are very happy to support both our existing and new customers’ product supply with this state-of-the-art additional capacity, which also represents a significant step in NextPharma’s growth strategy as a leading Europe-based CDMO,” said Peter Burema, chief executive officer, NextPharma. “Although today we celebrate the additional competitive capacity of solid dosage forms at our Goettingen site, we also continue to invest across all of our sites and capabilities, as we consider this to be imperative in order to meet the challenge of product supply within the pharmaceutical market, which has become even more visible during the Covid-19 crisis.”

NextPharma has a current footprint spanning five sites in Germany, one in France and one in Finland. It supplies products globally, with six of its seven sites FDA-approved. With expertise in solids, semi solids and non-sterile and sterile liquids, the company provides services from pharmaceutical development, clinical supplies, scale-up and process validation through to commercial manufacturing for a large range of dosage forms including tablets, capsules, granules, powders, pellets, gels, creams, sprays and syrups. Additionally, it provides a wide range of packaging solutions including blow-fill-seal, blisters, bottles, sachets, stick packs and tubes.

Construction of Biotechnology Park in J-K's Kupwara

Construction of biotechnology park in J-K's Kupwara paves way for new start-ups

The Kupwara district of Jammu and Kashmir, which was deprived of new developments, will soon house an industrial biotechnology park, which will offer state-of-the-art facilities to start-ups.

The park aims to help budding start-ups in the Valley to build innovation-led, knowledge-based bio-businesses.

The biotechnology park will be run by the Council of Scientific and Industrial Research (CSRI)-Indian Institute of Integrative Medicine (IIIM) and will act as the mentor institute in the development process of the area.

The construction work is being carried out by National Projects Construction Corporation (NPCC). Mohammad Younis, the site engineer of the project, told ANI that the construction work, which is estimated to cost Rs 33.1 crores is expected to complete by July 2021.

"The building will house 28 labs, meeting and conference room, media centers among other things. This state-of-art structure is expected to complete by July 2021, and the approximate cost of the building is Rs 33.1 crores," Younis said.

Bashir Khan, the Deputy Chairman of Handwara Municipal Corporation thanked the J-K administration for developing the area and promoting science and technology in the region.

"This park is a big project related to science and technology and is being constructed here. This biotechnology park will bring development in the area and promote scientific temperament. We are really thankful to the government for starting the project here," he said.

Local residents of the region also hailed the administration for the move.

"We are thankful to the government for promoting science and technology in the area. It will benefit the region and bring development here," said Mudasir Bhat, a local resident. (ANI)

Once completed, the park will offer state-of-the-art facilities to start-ups and biotech industries. The biotech park project will be run by the CSRI- Indian Institute of Integrative Medicine (IIIM) and it will act as the mentor institute in the development processes.

MHRA Approves VMIC Suites for COVID-19 Vaccine Manufacture

The suites, operated by Oxford Biomedica at its commercial manufacturing center, Oxbox, in Oxford, UK and are expected to be fully operational in October. 2021

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved a GMP manufacturing suite housing VMIC’s vaccine manufacturing equipment - resulting in two manufacturing suites to make a COVID-19 vaccine candidate.

The VMIC equipment will be operating at 1000L scale and will be dedicated to the manufacture of a COVID-19 viral vector vaccine candidate.

Supported by government funding through UK Research and Innovation, the collaboration between VMIC and Oxford Biomedica enabled the UK to establish a deployment center or ‘Virtual VMIC’ whilst the facility was being built with the aim of rapidly building capability in the UK to manufacture a vaccine for COVID-19 rather than wait until VMIC’s permanent facility opens in 2021.

The permanent VMIC facility, due to open in 2021, will be located at the Harwell Science and Innovation Campus in Oxfordshire, UK. Its envisaged that much of the work at the facility will be collaborative ventures with organizations ranging from small and medium sized businesses, through to large multinationals and NGOs such as Wellcome and CEPI, thereby underpinning the activity and strength of the UK in the vaccine area.

Dr Matthew Duchars, Chief Executive, The Vaccines Manufacturing and Innovation Centre, said: “This is a milestone moment in the UK’s fight against COVID-19. These suites, which house VMIC equipment, will have the ability to make tens of millions of doses of the current leading vaccine candidate.

“The approval from the MHRA is testament to the hard work and dedication of teams across VMIC, Oxford Biomedica and all the partners working with us on this vital project.“

Business Secretary Alok Sharma, said: “We need to be ready to manufacture a vaccine by the millions as quickly as possible if a breakthrough is made.

“Building up the UK’s capability to produce a COVID-19 vaccine at scale is an essential part of our pandemic response, which is why we have moved so quickly to establish a domestic manufacturing base from scratch.

“The approval of these two critical manufacturing suites will ensure we have even more capacity to protect the public as soon as a safe and effective COVID-19 vaccine becomes available.”

Andy Jones, Medicines Manufacturing Challenge Director at UK Research and Innovation (UKRI), said: “When we provided additional funding to both speed the building of VMIC and provide for a virtual manufacturing center, we recognized that we needed both innovative approaches to vaccine development and the ability to deliver vaccines at speed and in volume. The approval, by the MHRA, of the manufacturing suites and VMIC equipment will ensure that a vaccine can rapidly be manufactured once an effective vaccine is approved.”

JRS PHARMA's Changzhou, China Facilities Receive EXCiPACT GMP Certification

JRS PHARMA has announced the Rettenmaier Natural Fiber Manufacturing facilities in Changzhou, China, were awarded an EXCiPACT™ Certificate for Good Manufacturing Practices (GMP).

This demonstrates Rettenmaier Natural Fiber Manufacturing facilities operate according to the EXCiPACT Good Manufacturing Practice (GMP). The certificate helps drug manufacturers reduce efforts and costs as they need to either perform audits of new suppliers or commission 3rd party physical audits to demonstrate GMP compliance. With the institution of new travel restrictions due to COVID-19, EXCiPACT certificates offer customers risk assessment assurance without the need to travel.

JRS PHARMA's line of Microcrystalline Cellulose products produced at the Changzhou facility includes VIVAPUR®, the premium tablet binder designed for specific formulation needs. MCC is an odorless, tasteless, white powder with a high degree of brightness, derived from highly purified wood pulp. With a wide range of chemical, technical, and economic benefits, MCC is one of the most widely used binder excipients for solid dosage forms.

Firmenich Opens Biotechnology Pilot Plant in Geneva

Firmenich (Geneva, Switzerland) announced the opening of its new biotechnology and naturals pilot plant and laboratory in Geneva. Benefiting from the latest digital technology, the facility opens a new era for the development of ingredients and clean label solutions by providing faster speed-to-market and greater flexibility for customer collaboration. Integrated into the Group’s flagship ingredients production site at La Plaine, Geneva, the facility operates to the highest safety and environmental standards, reducing waste and energy consumption.

“With our new biotechnology pilot plant closely connected with the ingredients production site, Firmenich provides integrated biotech development all the way down to the finished product, without any gaps,” said Genevieve Berger, Chief Research Officer, Firmenich. “Opening a new era in ingredients creation, our pilot plant and laboratory harnesses new technologies to improve clean label solutions, while the latest digital innovation maximizes efficiency.”

“Our new pilot plant provides greater flexibility to respond to customer needs in product development,” said Sarah Reisinger, Senior Vice President Research Operations, Firmenich. “Capable of handling multiple projects simultaneously, it also enables small scale production of trial batches for formulation or testing and regulatory validation.”

Operational this month, the pilot plant at La Plaine is a cornerstone for new ingredients for both perfumery and flavors, enabling the development of the most efficient and high-quality production processes through biotechnology or natural extraction. Harnessing digital technology for increased automation, the pilot plant is able to move from single to continuous batch process, increasing efficiency, speed and reducing the use of raw materials.

In keeping with Firmenich’s recognized track record in sustainability, the new pilot plant benefits from efficient bioreactors, which minimizes both the amount of waste produced and energy consumed.

Upcycling an existing building at the Firmenich site in La Plaine, the new facility benefits from full synergies with the ingredients production plant. State of the art safety and environmental features were also designed into the new pilot plant and laboratory.

BioNTech to Acquire Novartis GMP Manufacturing Site

BioNTech announced the signing of a share purchase agreement with Novartis AG, Basel / Switzerland to acquire their GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021, thanks to the established team and well-established drug substance and drug product manufacturing capabilities at the site.

The Marburg production site is a multi-platform GMP certified manufacturing facility that currently employs approximately 300 people. It is fully equipped for the production of recombinant proteins as well as cell and gene therapies, and holds cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion. Novartis has significantly invested in the site over the past five years, which is located in a life science industry park that is home to more than 10 companies with 6,000 employees in total, and also provides an excellent infrastructure for the company. The industrial park is located within one hour from the Frankfurt airport and within 90 minutes from BioNTech’s headquarters in Mainz, Germany.

“This acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval. We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise. From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation,” said Dr. Sierk Poetting, Chief Financial Officer and Chief Operating Officer at BioNTech.

The acquisition will accelerate BioNTech’s efforts to scale-up its commercial manufacturing capacity to produce its mRNA COVID-19 vaccine candidate BNT162. The BNT162 program includes five mRNA vaccine candidates currently in clinical testing in the United States, Europe, South America, and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase 3 trial.

The facility is expected to operate as one of the largest mRNA manufacturing sites in Europe alongside two of BioNTech’s existing GMP facilities which currently produce the COVID-19 vaccine candidates for clinical trials, and in addition to at least four Pfizer production sites in the United States and Europe.

The Marburg facility is expected to start the production of mRNA and the LNP formulation for a COVID-19 vaccine in the first half of 2021, pending regulatory authorization or approval. BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccine, antibody, and cell and gene therapy product candidates to support the development of its diversified cancer and infectious disease product pipeline.

In addition, BioNTech intends to use the Marburg facility to contribute to the production of the COVID-19 vaccine for global supply, including to China, where it is partnered with Fosun Pharma, subject to regulatory authorization or approval.

BioNTech and Novartis anticipate completing the transaction in the fourth quarter of 2020, subject to regulatory approval and the satisfaction of certain other customary closing conditions.

SANITIZED Teccenter In-House Microbiology Lab Certified by IAC

SANITIZED, Switzerland-Based, the specialist for antimicrobial textile specialist receives IAC certification material protection and hygiene function in textiles and polymers, had its in-house microbiology laboratory in the SANITIZED TecCenter certified by IAC, the International Antimicrobial Council.

To ensure responsible use of biocides and international comparability, test methods and test results for antimicrobial treated products must be transparent, useful and comparable. This is precisely why SANITIZED used this non-profit, US-based institute to increase safety for antimicrobial-treated products and for consumers.

Textile and polymer product manufacturers value the assistance that the in-house SANITIZED TecCenter provides them with developing and optimizing their products. It supervises technical application aspects, and conducts microbiological tests and analytics - all from a single source.

SANITIZED provides specific assistance with the textile manufacturer's R&D work, particularly for the demanding challenge of developing the best possible odor-management for textiles. Now the TecCenter has been certified by the IAC and is a designated "International Antimicrobial Council Certified Laboratory."

Thanks to the IAC Certification, SANITIZED AG now offers innovation expertise according to international standards that are also recognized and valued in the US and Asia.

"In addition to assistance with product development and product optimization from our TecCenter, SANITIZED customers receive certification of the antimicrobial treatment of their products from an independent organization, the IAC," explained Erich Rohrbach, Head of Microbiology at SANITIZED AG.

"This is an important building block for production chain transparency in the textile industry, which is demanded by a growing number of manufacturers and brands that are driven by end customer requirements," added Erich Rohrbach.

Lonza Opens Facility for ADC Payload Manufacturing

Expansion is based on agreement with a major biopharma partner that ensures ADC payload supply continuity and flexibility.

Lonza, a specialty CDMO partner to the biopharma industry, has inaugurated the first of two manufacturing suites for antibody-drug conjugate (ADC) drug-linker (payload) manufacturing at the Visp, Switzerland site. This first manufacturing suite handles compounds with occupational exposure levels down to 1ng/m3 and is dedicated to the manufacturing platform for ADC drug linkers. This expansion underlines the strategic position of ADCs in the Lonza portfolio, with the company developing and producing all components of these increasingly important cancer treatments: cytotoxic payloads, antibodies and the required linkers on one site.

Due to COVID-19 measures, the opening was held as a virtual opening ceremony, connecting multiple customers and Lonza sites worldwide after the first process validation was completed successfully and manufacturing for in-market supply started.

The first of two state-of-the-art, highly-potent API (HPAPI) suites supports a global biopharmaceutical partner by securing their long-term supply of highly-potent ADC payloads. The suite has been in operation since March of this year. A second suite will become available to other customers early in 2021 for similar HPAPI and payload development and manufacturing programs.

These new suites will extend the options for companies developing APIs with even higher potencies. In addition, they will increase Lonza’s capabilities to provide fully scalable HPAPI and ADC solutions from lab to commercialization, supporting the accelerated timelines that many drug programs in this category require.

“Supply from the facility is critical, and by supporting one of our global partners in the oncology field, we are enabling the treatment of many cancer patients,” said Maurits Janssen, strategic business development small molecules, Lonza. “Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates. We continue to add capabilities and capacity to meet the development and manufacturing needs of our partners in this field to answer to their increasing demand.”

Gordon Bates, president small molecules, Lonza, said, “This partnership is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models. Our customers developing highly potent and increasingly complex medicines need a partner whom they can trust to handle these toxic substances throughout their lifecycle and to deliver in sync with their needs, whether for clinical or for commercial supply. Our partner has recognized the value in combining expertise in biologics and chemistry on one site and this investment has expanded our collaboration.”

Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine

Establishment of additional lipid production in Germany for use with mRNA-based vaccines.

Evonik is investing in the short-term expansion of its specialty lipids production which are essential for mRNA-based COVID-19 vaccines. Commercial lipid quantities are to be produced at Evonik’s Hanau and Dossenheim sites in Germany as early as the second half of 2021 as part of a strategic partnership with vaccine manufacturer BioNTech. This step contributes to increasing the supply security of the Pfizer-BioNTech COVID-19 vaccine.

"The pandemic requires decisive action," said Christian Kullmann, chairman of Evonik’s executive board. "We are therefore doing everything possible to supply our partners with the critical lipids they need. At the same time, we are expanding our production capacity and competencies along the entire value chain."

Lipids are fundamental to produce highly effective mRNA-based vaccines. Only with an increase in lipid supply can the volume of vaccine be further increased. This move marks an expansion of the strategic partnership between Evonik and the vaccine manufacturer BioNTech.

In mRNA-based vaccines, the mRNA is enclosed in a lipid nanoparticle (LNP) that is comprised of specific lipids. The LNP protects the mRNA and delivers it safely into the cell. There it is released so that the vaccine can exert its effect. Evonik has been a contract development and manufacturing organization (CDMO) leader for advanced drug delivery for many decades, supporting pharmaceutical companies worldwide in the development and production of complex parenteral drug products that require formulation technologies such as lipid nanoparticles.

The Germany-based company is one of the few integrated development and manufacturing partners for cell and gene therapies, and has been actively involved in various mRNA-based vaccines projects for COVID-19.

"With our partnership with BioNTech, we are systematically expanding our leading position as an integrated development partner in cell and gene therapies," said Thomas Riermeier, head of Evonik's Health Care business line. Evonik’s portfolio includes pharmaceutical excipients such as lipids, as well as CDMO services for the formulation development, GMP manufacturing and aseptic filling of complex parenteral drug products.”

Kaneka Eurogentec Expands Capabilities

Receives GMP accreditation for new mRNA manufacturing facility, COVID-19 vaccine production ongoing.

Kaneka Eurogentec, a custom service and FDA inspected contract development and manufacturing organization (CDMO), received GMP accreditation by the Belgian ministry of health for the GMP manufacturing of messenger RNA (mRNA).

The new facility audited and accredited by Belgian Authorities will allow the production and the purification of up to 10 g scale (up to 1 million doses of vaccine) of RNA for use in human clinical trials and commercial supply, with potential for expansion.

“Manufacturing GMP mRNA complements perfectly our ongoing GMP DNA manufacturing activities providing a one-stop-shop offering Plasmid DNA, linearization and mRNA production,” said Lieven Janssens, president and chief executive officer, Kaneka Eurogentec. “It’s definitely the ambition of Kaneka Eurogentec to become the world leading CDMO for mRNA, as we are already for the production of plasmid DNA.”

The company says two customers have already signed for three mRNA sequences including for early phase COVID-19 clinical trials.

AmbioPharm Opens New Shanghai Campus

Adds European executive team members working out of new Zurich office.

AmbioPharm Inc., a provider of peptide API CDMO services, has recently opened its new Shanghai campus. The new campus adds nearly 538,000 sq. ft. (50,000 square meters) of manufacturing, quality control and administrative space.

“We have added 4 new buildings which add to our solid-phase and liquid-phase peptide facilities at our Shanghai production site positioning AmbioPharm as the go-to source for all peptide API needs that our partners have. This is in addition to the manufacturing expansion which was completed at our U.S. headquarters in mid-2020,” said Chris Bai, chief executive officer and co-founder, AmbioPharm.

Additionally, AmbioPharm has established a new office in Zurich, Switzerland which is headed by Kathleen Noack, vice president of European sales and marketing. Additionally, Michael Postlethwaite, sales director, has joined the AmbioPharm Europe team also working from this new office.

“We are delighted to add two highly experienced seasoned professionals to our European team. Both Ms. Noack and Dr. Postlethwaite come with a wealth of peptide API development knowledge to establish and extend our European partnerships,” said Jim Hampton, executive VP of GMP Sales and co-founder.

AmbioPharm is a leading and innovation-driven company specializing in the development and manufacture of peptides and peptide-related products. With a comprehensive range of services, AmbioPharm produces custom products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide. Headquartered in the United States of America and with locations in Europe, the USA and Asia, AmbioPharm operates internationally with over 14 years of experience and expertise.

Minaris Invests to Expand Cell and Gene Mfg. Facilities

New buildings near Munich, Germany and Yokohama, Japan will more than double capacity for commercial manufacturing of regenerative medicines.

Minaris Regenerative Medicine, a global contract development and manufacturing organization for cell and gene therapies, is investing $64.5 million to significantly expand its facilities in Europe and Asia.

A new state-of-the-art facility will be built near its existing site in Ottobrunn near Munich, Germany with a total investment of $40.7 million. The new facility will operate according to GMP standards (FDA and EMA) and be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies. The 71,554 sq. ft. (6,650 square meter) building will initially more than double Minaris’ existing capacity in Europe by providing additional cleanrooms, quality control labs, warehousing, cryo-storage and office space.

The new facility is expected to be operational early 2023 and will allow for additional expansion of cleanrooms according to client demand and specifications, thus more than tripling the current cleanroom capacity.

“We are very pleased to expand our capacity to support the growing demand of clients who continue to care for an increasing number of patients in the future,” said Dusan Kosijer, Managing Director of Minaris Regenerative Medicine GmbH.

Also, a new facility will be established adjacent to the existing facility in Yokohama, Japan allowing for an additional 43,040 sq. ft. (4,000 square meters), which will double the capacity for commercial manufacturing of regenerative medicine. The new facility is scheduled to start operations in October 2022. The $23.8 million investment is part of a strategy to establish a center for cancer immunotherapy and somatic stem cells.

The European and Asian expansions complement the opening of the new commercial facility in Allendale, NJ announced in January this year.

“Our investment in the facility expansions of all our three regional sites confirms our commitment to contract development and manufacturing for the cell and gene therapy industry,” said Kazuchika Furuishi, PhD, Corporate Officer and General Manager, Regenerative Medicine Business Sector of Showa Denko Materials Co., Ltd. “Our global offering to our clients with sites in USA, Germany and Japan enables us to advance our clients’ life-saving therapeutics to patients in need around the world.”

Eurofins CDMO Expands Drug Product Capabilities in Canada

Eurofins CDMO has expanded its existing drug product operation capabilities with the early 2020 completion of its new drug product development and cGMP manufacturing facility, located in Mississauga, Canada.

The expansion of Eurofins’ drug product operations spans 14,500 square feet. The assets include fully equipped state-of-the-art pre-formulation and formulation development laboratories, a development suite, multiple GMP manufacturing suites, clinical packaging, and warehousing. With the expansion, Eurofins CDMO can support development and clinical manufacturing of oral solid dosage forms, including highly potent APIs. The integration of drug product operations compliments Eurofins’ existing API development and manufacturing services by providing an enhanced Quick-to-Clinic drug product strategy designed to meet clients’ needs for phase I and II products.

The company says this complement of services offers science-driven strategies which enhance the drug product performance of APIs, from IND enabling through to late stage programs. The new drug product facility allows Eurofins CDMO to offer all drug development services under one roof, achieving enhanced science faster.

Ajinomoto Bio-Pharma Services Expands Small Molecule Manufacturing Capabilities

Ajinomoto Bio-Pharma Services (“Aji Bio-Pharma”), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce a major expansion of small molecule manufacturing capabilities with the addition of a new production facility in Visakhapatnam, India. Construction of the 91,460 sq. ft. (8,500 square meter) facility began at the end of July 2020 and is expected to be completed mid-2022.

To meet the current and future needs of customers, the new small molecule manufacturing facility doubles the production capacity at the site to 310 m3 for active pharmaceutical ingredients (API) and intermediates and has dedicated equipment to manage OEB 4 high potency ingredients. Further, the site has completed renovations on existing laboratory space to support additional R&D activities. It is estimated that the expansion will create at least 60 new jobs at the site.

The US FDA approved Ajinomoto Bio-Pharma Services India manufacturing site, which was designed, constructed and is managed based on the Aji Bio-Pharma Belgian sites’ GMP operating standards and quality systems, has successfully supported a number of the world’s leading biopharmaceutical companies since its formation in 2011 and continues to win awards for sustainability and quality standards.

“We are very excited to be investing in this additional production capacity to continue delivering high quality, cost-effective small molecule manufacturing services for our customers,” said K.V.V. Raju, Head of Site Operations and CEO, Ajinomoto Bio-Pharma India Pvt. Ltd. “This expansion exemplifies our commitment to our vision statement of being a leading, trusted, innovative partner to our clients and our people.”

“The increased manufacturing capacity at Aji Bio-Pharma India offers a significant advantage for our small molecule customers, who now have a variety of options to meet their manufacturing needs,” said Peter Stuyck, Sr. Vice President and Head of European Operations, Ajinomoto Bio-Pharma Services. “This expansion optimizes capacity across all locations and further enhances Aji Bio-Pharma’s commitment in being a leading global and quality-driven CDMO with comprehensive service offerings.”

About Ajinomoto Bio-Pharma Services:

Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs. Learn more: www.AjiBio-Pharma.com

Romark Announces FDA Approval of New Manufacturing Facility in Manati, Puerto Rico

Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s manufacturing facility in Manati, Puerto Rico for the production of ALINIA® (nitazoxanide) tablets, 500 mg and ALINIA® (nitazoxanide) for Oral Suspension, 100 mg/5mL in the U.S. market.

The new state-of-the-art facility encompasses approximately 35,000 square feet and is equipped with suites and equipment to produce tablets, powders and other oral solid dosage forms.

“This is a major milestone for us, as it allows us to expand our capacity to develop and deliver medicines,” said Marc Ayers, President and Chief Executive Officer of Romark.

Romark has invested more than $80 million in establishing its Puerto Rico operations and now employs 100 people in the manufacturing facility and an analytical laboratory it acquired in 2018. With a planned expansion of the facility, the company’s Puerto Rico operations are expected to grow to a total of approximately 400 employees over the next three years.

The Puerto Rico facility is strategic to the company’s plans to manufacture and distribute its investigational new drug, NT-300 (nitazoxanide extended-release tablets), which is currently undergoing Phase 3 clinical trials for both the prevention and treatment of COVID-19 and other viral respiratory illnesses.

About Romark:

Romark is a vertically-integrated, research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases. Romark has operations in the United States, Puerto Rico and Europe, and it conducts research and development and commercializes its products globally.

Romark is a leader in developing new drugs for treating a broad range of seasonal, emerging and drug-resistant viral respiratory illnesses. It is also developing a new product aimed at inducing functional cure of chronic hepatitis B. Products discovered, developed and commercialized by Romark have been used to positively impact the lives of more than 400 million people worldwide.

Eurofins Expands Chemistry Capacity

New Building Nearing Completion at Eurofins Discovery’s Flagship Chemistry Site at Eurofins Villapharma in Murcia, Spain

Eurofins Discovery is expanding its footprint to serve the growing market of outsourced drug discovery with its high-quality chemistry capabilities. Eurofins Villapharma is Eurofins Discovery’s flagship center for synthetic chemistry, focused on supporting growth in chemistry services and Eurofins Discovery’s integrated drug discovery business, branded DiscoveryOne™.

A new 63,000 square foot facility will initially support chemical synthesis and purification, more than doubling Eurofins Discovery’s current capacity. The state-of-the-art facility will provide chemistry capacity and capabilities and enable new, associated services. The building’s design utilizes lean principles, optimizing sample and supply flows with laboratories demonstrating a modern and functional design to support industry demand for key productivity metrics. The $14M investment provides the facility and footprint for continual growth into the future.

Located in Murcia, Spain, the new site preserves the proximity to the original Eurofins Villapharma site. Historically, Villapharma has been associated with the University of Murcia, the largest university in the area, that is well known for creating the Medicinal Chemistry Chair that provides training and education to Ph.D. candidates. Eurofins Villapharma continues to support students in their Ph.D., adding value to the community while gaining access to a pipeline of well-trained chemists to meet the new building’s additional capacity.

The construction project is scheduled to conclude in September of 2020, with the laboratory build-out and grand opening in early 2021.

About Eurofins Discovery:

Eurofins Discovery, a business operating under the Eurofins BioPharma Services division, has supported Drug Discovery research for over 40 years. Eurofins is recognized as the industry leader for providing drug discovery researchers the largest and most diverse portfolio of standard and custom in vitro safety & pharmacology assays and panels for drug screening and profiling. In addition to in vitro safety pharmacology strengths, we also offer a broad portfolio of over 3500 drug discovery services and 1800 products. These include in vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities. We support a variety of drug discovery targets such as GPCRs, Kinases, Ion Channels, Nuclear Hormone Receptors and other proteins & enzymes. The Eurofins Discovery capabilities, expertise, knowledge and skill sets enable the company to provide clients the benefit of being able to work with a single outsourcing provider (CRO) for all their drug discovery programs.

About Eurofins – the global leader in bio-analysis

Eurofins Scientific believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in esoteric and molecular clinical diagnostic testing.

With over 48,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability, and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services.

As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.

Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

Frontida BioPharma Completes Facility Expansion

Frontida BioPharm Inc. has completed a facility expansion to its oral solid dose manufacturing operations with the commissioning of a Highly Potent Compound Contract Manufacturing Suite. This addition features 1000 sq. ft of readily available, hazard-certified production space.

Key service equipment and set-ups include a large-scale Roller Compactor, Milling Room, Bin Blender, Tablet Press, and ingress and egress airlocks with enhanced personnel controls. Frontida will utilize these capabilities to streamline clients' goals for the development of flexible and scalable manufacturing processes for clinical trial materials through commercial product operations.

Highly potent compounds serve an increasingly significant role in numerous R&D landscapes and pharmaceutical intensive medical treatments; i.e. oncology, atrial fibrillation, osteoporosis. In order to produce these products, a thorough process of product risk analysis is required in order to maintain a consistent manufacturing balance between production scale, market distribution and demand requirements. As a key step to utilize this new suite, Frontida's manufacturing assessments will verify each highly potent compound's level of toxicity, potential personnel and facility exposure limitations.

"The addition of a highly potent suite at Frontida Biopharm Inc. leverages the internal know-how and capabilities of our existing product development and manufacturing teams. The expert personnel leading this 'suite' new expansion contribute an average of 20 years practical experience to every project. Each prioritizes the safety and well-being, OEL guidelines, effluent containment practices, responsible air emissions, and sanctioned waste removal needed in order to better serve our pharmaceutical clients," commented Anthony Qu Ph.D, chief operating officer.

"This area will expand Frontida's capabilities to our customers, further assuring that our culture of excellence and production quality is maintained through high grade service options, and top-of-the-line technological advantages," added Renard Jackson, executive vice president of CMO Services.

Dräger Sets Up Respiratory Mask Production Facility In The UK

In connection with the COVID 19 pandemic, Dräger has received an order from the British government to deliver respiratory protection masks (FFP3). The delivery of the order will start in 2020 and will stretch until the end of 2021. The expected net sales are roughly EUR 100 million.

For this purpose, a mask production facility will be set up in the UK, in the Blyth area of Northumberland. There, Dräger has had a development and production site for respiratory protection technology for firefighters and industry for over 50 years.

This is in addition to the existing production network in Sweden and South Africa and the recently decided new production sites in France and the US. The investment in the expansion of production capacities across all five production sites will require a mid-double-digit million euro amount in the 2020 financial year.

Rainer Klug, Chief Officer of Safety Division at Dräger: "We are very pleased about the major order from the British government. It gives us the opportunity to expand our international production network for FFP masks."

"With this additional production unit, Dräger will increase volumes quickly and flexibly," Klug said. "Our international production network enables us to react very quickly and specifically to national or local requirements on the one hand, and to cover international requirements in a closely networked and flexible manner on the other. Dräger thus operates a highly responsive manufacturing system for certified FFP respiratory protection masks, with a product design originating from our own development in Germany."

Bora Pharmaceuticals Completes Acquisition of Former GSK Facility

Bora Pharmaceuticals Co., Ltd announced that the contract development and manufacturing organization (CDMO) has successfully completed the acquisition of GSK's Mississauga, Ontario (Canada) facility.

Initially announced in March 2020, the site represents Bora Pharmaceuticals' first manufacturing facility in North America and will become home to its North American headquarters.

Establishing the Mississauga site as a core part of the CDMO's global manufacturing network is part of a long-term growth strategy that has seen Bora Pharmaceuticals complete three M&A deals in the past five years.

"Completing the acquisition marks a major step in our expansion into North America, bringing us closer to many of our current and future customers," said Bobby Sheng, CEO of Bora Pharmaceuticals. "The Mississauga site strengthens our existing state-of-the-art manufacturing network, broadening our capabilities and almost doubling our number of talented colleagues, so that we can continue to support the current and future needs of our customers."

Through this acquisition, Bora Pharmaceuticals broadens its range of dosage forms and becomes one of the leading global suppliers of formulation development and manufacturing services.

The addition of the site enables Bora Pharmaceuticals to produce 50 different products to 100 markets worldwide. The transaction includes a minimum five-year supply agreement with GSK.

Interest has already been expressed in Bora Pharmaceuticals' capabilities in the region, with the company confident that its international reputation will help strengthen Canada's medicines supply chain.

"Our government is proud that Bora chose Ontario for this significant investment. We have a world-class life sciences sector, and this new investment by Bora will strengthen it even further," said Vic Fedeli, Ontario's Minister of Economic Development, Job Creation and Trade. "Our workforce is the best in the world, and certainly up to the challenge of helping Bora grow and thrive here in Ontario."

"By choosing Mississauga for its flagship North American facility, Bora Pharmaceuticals has reinforced what so many other notable companies already know – that the life sciences sector is thriving in our City and it's the perfect location to call home," said Mayor Bonnie Crombie. "As the second largest life sciences sector in Canada, the talent pool of scientists, experts and engineers in Mississauga is driving technologies and innovations used worldwide. I'm thrilled to welcome Bora Pharmaceuticals to this illustrious group."

Whilst the company will retain the vast majority of the workforce at the site, Bora Pharmaceuticals plans to hire additional employees to further strengthen its technical and operational team in line with its growth plans.

The Mississauga location will help Bora Pharmaceuticals develop its growing customer base in North America, following on from the opening of its US offices in Delaware during 2019.

About Bora Pharmaceuticals Co., Ltd:

Now employing over 900 people, the publicly listed (6472.TWO) Bora Pharmaceuticals is a premier international CGMP CDMO specializing in complex oral solid dose (tablet & capsules), liquids (solutions, suspensions, & nasal sprays) and semisolid (creams & gels) pharmaceutical products for late-phase Clinical through Commercial manufacturing and packaging. Bora owns and operates three state-of-the-art CGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. Our TAA-compliant sites deliver to more than 100 markets around the world including the USA, Canada, EU, Southeast Asia, Middle East, and South and Central Americas. For further information please visit www.boracorpcdmo.com

https://www.boracorpcdmo.com

Bushu Pharmaceuticals’ Manufacturing Facility Expansion, Misato, Japan

Bushu Pharmaceuticals unveiled a new expansion program for its pharmaceutical manufacturing facility in Misato, Japan, in August 2020.

With the estimated investment of $100m, the new capital program will expand the company’s footprint, capability, and range of services to the clients. The program will be implemented over the next five years.

The additional capacity and inspection lines in the facility will facilitate the entry of greater volume of bulk goods into the country, making the clients’ logistics and supply chain processes competent.

Established by Eisai in 1981, the Bushu Pharma’s Misato facility is located in Misato-machi, Kodama-gun, in Saitama prefecture.

The site covers an area of approximately 1,861,480 sq. ft. (173,000m²), divided into a pharmaceuticals manufacturing area and welfare facilities area, including a gymnasium and park.

The facility has a floor area of approximately 613,320 sq. ft. (57,000m²), encompassing a solid dosage manufacturing building, an injectables building, a warehouse, and a quality control (QC) space.

The expansion program of the manufacturing facility includes the addition of a new cold chain warehouse facility spanning 41, 964 sq. ft. (3,900m²). It will be utilized to store temperature-controlled sterile drugs and biologics for export to the market in Japan.

The ground-breaking ceremony of the new cold chain center was held in September 2019.

Cognate Increases Cell, Gene Therapy Manufacturing with New Plants

Cobra Biologics, Cognate’s gene therapy unit, is embarking on a multiphase upgrade of its plasmid DNA services. The company will add new clinical and commercial DNA facilities at its existing European operations in Sweden and the U.K., teeing up a fourfold jump in high-quality DNA manufacturing, Cobra said.

As for when Cobra’s expansions may come online, it is complicated, the spokesperson said.

“We are planning the capacity to match the demand in the industry and can speed up some of these if needed, and as needed by our clients,” he added.

McIlvaine Company

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