PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Novo Nordisk Expands Insulin Manufacturing Site

The Danish drugmaker has announced another investment at its diabetes finished products manufacturing facility in North Carolina, US.

Novo Nordisk will invest $22m (€19m) in new production lines at its Clayton plant, where the firm conducts formulation, filling, inspection, assembly and packaging of diabetes and obesity medicines.

The expansion, which will add 22 jobs to the site, is due to be completed in 2020.

The announcement comes 10 months after announcing a $65m boost in production capacity at the same site, and follows a $2bn investment across the drugmaker’s active pharmaceutical ingredient (API) and production plants in Clayton, US, and Måløv, Denmark, in 2015.

Johnston County, home to Novo Nordisk’s Clayton facility, is supporting the investments via a seven-year package of financial incentives for the Danish firm.

Novo Nordisk currently hires approximately 1,200 staff across the county and, once expansions are complete the API plant, will employ 700 at that site alone.

“This global biopharma company has made our county a visible part of its production strategy, and I think that says all the right things about our business climate,” according to chairman of the Johnston County board, Ted Godwin.

Chad Henry, corporate VP and general manager of Novo Nordisk’s diabetes finished products manufacturing site, similarly highlighted the public-private partnership.

“Just as seriously as we take the vital role we play in producing innovative medicines for people with diabetes and obesity, we take great pride in creating jobs and supporting economic growth in Johnston and neighboring counties in the ‘Biopharma Crescent’ region,” he said.

WuXi AppTec Expands Site in California for Pharmaceutical R&D Services

WuXi AppTec's newly expanded facility will establish a center of excellence in screening, discovery biology, pharmacology, and small molecule process R&D including phase I GMP manufacturing. The expansion will provide key elements of WuXi's small molecule capability and technology platform under one roof, further enhancing services to North American pharmaceutical and biotech industries. WuXi will also add extensively from the local talent base, further contributing to regional economic growth.

"Having a leading global organization like WuXi significantly invest in San Diego highlights the value of international partnerships, the county's place on the Pacific Rim and our region's long-standing support of the life sciences community," said San Diego County Supervisor Ron Roberts. "I especially applaud the company's vision that 'every drug can be made, and every disease can be treated.'"

"The San Diego life science community continues to thrive with the commitments and investments made by leading international powerhouses like WuXi AppTec," said Joe Panetta, president and CEO of Biocom. "Their latest facility expansion in San Diego is a testament to the deep relationships they have built with the local biotech community. Biocom applauds the positive impact they've had on the region's economic growth and innovative healthcare products for our patients."

"This expansion will enable us to better serve our U.S. and global customers, and contribute to the growth and success of the dynamic San Diego biotech ecosystem," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "Together with our ecosystem partners, we will continue to strengthen WuXi's capability and technology enabling platform to expedite the discovery and development of new medicines for patients worldwide, and for a future where every drug can be made and every disease can be treated."

DPS Group and Hodess Cleanroom Construction Completed Facility For Mustang Bio

DPS Group, a privately-owned, global engineering company, and Hodess Cleanroom Construction, a comprehensive cleanroom construction company announced they have completed a proprietary cell therapy manufacturing facility for Mustang Bio, Inc., a clinical-stage biopharmaceutical company.

Mustang Bio engaged Hodess as prime consultant on the design/build project, and Hodess selected DPS Group for its depth of experience designing current cGMP manufacturing facilities. DPS Group’s office provided architectural and engineering services for the new facility.

Located within UMass Medicine Science Park in Worcester, the 27,000-square-foot facility will support the clinical development and commercialization of Mustang’s CAR T and gene therapy product candidates and enable proprietary cell therapy research. The project focused on upgrading existing office and laboratory space, and converting existing labs into three cGMP ISO7 clinical production areas.

The flexible design met Mustang’s current workplace and manufacturing needs in approximately 12,000-square-feet of the facility, providing ample space for future expansion. Other facility improvements included HVAC, mechanical, and fire protection system upgrades and the installation of a new air handling unit customized for increased air flow to the cGMP spaces. Energy efficient lighting and lighting controls were also added.

“The opening of our cell therapy manufacturing facility is a significant milestone for Mustang Bio because it will enable us to process personalized cell therapies for the treatment of aggressive forms of cancer and continue to advance the research in support of our gene therapy for X-linked severe combined immunodeficiency (X-SCID),” said Manuel Litchman, M.D., president and chief executive officer of Mustang Bio. “DPS Group and Hodess Construction brought a seamless design/build approach and expertise in cleanroom design and construction that helped successfully complete the project. We look forward to growing our clinical and chemistry, manufacturing and controls teams in this specialized facility.”

Serving high-tech industries around the world, DPS designs and builds facilities that turn scientific innovations into life-saving and life-enhancing products. The firm delivers full-service engineering across a range of disciplines, including project management, procurement, design, construction management, health and safety management, commissioning, qualification and facility start-up.

DPS Group is a global engineering, consulting and project management company, serving high-tech industries around the world. It has an office in Framingham.

DPS delivers services for clients across the complete engineering and construction value chain including feasibility studies, concepts, consulting, architecture, engineering, procurement, construction management, commissioning, qualification and validation; as well as contingent staffing solutions.

DPS applies its extensive Process Engineering expertise built over 44 years, as well as significant Lean Construction experience to assist our clients in high-end process sectors such as pharmaceuticals, biotech and semiconductors deliver their manufacturing facilities speedily, safely and cost effectively. What sets us apart are the partnerships we build with our clients through a fundamental understanding of their businesses and our own agility, flexibility, original thinking and our high-caliber people.

Mustang Bio, Inc. (“Mustang”) is a clinical‐stage biopharmaceutical company focused on the development and commercialization of a broad range of proprietary chimeric antigen receptor engineered T cell (CAR T) immunotherapies and gene therapies in areas of unmet need. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for X-SCID.

QPS Expands US-Based Capabilities

QPS announced the expansion of its U.S.-based Phase I clinical trial capabilities to support the growing needs of its pharmaceutical, biotechnology and CRO partners. To fill their drug pipelines, large pharmaceutical and biotechnology companies are buying promising drug compounds that have been developed by small biotech companies up to the point of candidate nomination. These promising compounds then become candidate drugs that the large companies put through rigorous testing and analysis before potentially being reviewed and assessed for approval by the FDA.

"We've seen this trend evolve and have expanded our Phase I clinical trial capabilities to better serve the hundreds of smaller companies developing potential new drugs. We have completed more than 150 Phase I trials and this expansion will enable us to support exponentially more sponsors as they progress compounds through proof of concept and First-in-Human trials to the point of candidate nomination," said CEO Benjamin Chien, QPS. "This strategic expansion complements our work with pharmaceutical and biotechnology companies, as well as our CRO partners, where we have successfully conducted more than 1,300 Phase I-IV clinical trials for drug candidates."

"Engaging smaller biotechnology companies is key in expanding QPS Phase I capabilities, and these companies don't have large research or clinical pharmacology departments," said Chien. "We appointed Marcelo Gutierrez, PhD, to serve as our director of clinical pharmacology so sponsors can tap into his vast experience working for three well-known pharmaceutical companies. His guidance with respect to the safe translation of drugs into humans, protocol design, and interpretation of preclinical data and results, will be invaluable to sponsors seeking nomination for promising drug compounds."

"Our pipeline is filled with sponsors that need this level of support. The amount of First-in-Human studies are rapidly increasing and there are very few sites across the country that can conduct them," said Gutierrez. "QPS is well-known for its success in First-in-Human studies. We excel at complex and special population Phase I trials, and our enrollment and completion rates are among the best in the industry."

Sandra Pagnussat, MD, joined QPS as a primary investigator dedicated to Phase I trials. She brings to QPS expertise in internal medicine, pediatrics and rheumatology. Since the enactment of the FDA Safety and Innovation Act (FDASIA) in 2012, the number of pediatric clinical trials have increased. More than 436 separate studies that enrolled around 56,000 children have been performed, and the FDA has issued approximately 340 written requests for new pediatric studies.

"We expect this demand for pediatric studies to continue," said Pagnussat. "Pediatric trials are specialized and unique. And they are in high-demand, particularly for companies that want to extend their patents to include pediatric patients."

QPS also appointed Aliza Lipson, MD, an adult rheumatologist, to the role of primary investigator dedicated to late-phase clinical trials.

"This hire enables QPS to extend the Phase I rheumatology and autoimmune disorder work QPS is already doing under the direction of Martha Hernandez-Illas, MD, medical director of the QPS Phase I Unit, to late-phase clinical trials," said Chien.

QPS has increased early-phase clinical capacity by more than 20 percent at its clinical site in Miami, FL.

Additionally, QPS doubled its specialty lab space at the Miami site and co-located it with its Miami-based clinical site.

"In the market, you'll find CROs that offer clinical services, and then you'll find specialized labs. At QPS, we now we have the unique combination of clinical services and a specialized lab combined under one roof," said Chien. "And, that's important because many of our studies require lab samples to be processed quickly, in less than eight hours. Having our clinical site and specialty lab co-located makes this possible."

PCI Expands Cold Chain Infrastructure

PCI Pharma Services (PCI) has completed a -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.

The site, located in Rockford, IL, features packaging and labeling services, logistical services for global storage and distribution, as well as onsite analytical laboratory services. PCI's Rockford location provides end-to-end support for cold chain requirements, with temperatures including 15-25°C, 2-8°C, -20°C, -40°C, -80°C as well as cryogenic storage at -196°C, and is one of eight global locations supporting medicines destined to more than 100 countries around the world.

PCI initiated the design of the dedicated -40° facility with very specific requirements based on the infrastructure needs set forth by the client. With a collaborative approach, PCI provided insights and expertise from its cold chain experience to deliver the optimal solution to ensure conformance to the drug requirements as well as mitigate various risk factors in the global supply chain.

The completed specialized Cold Chain storage facility spans more than 10,000 square feet and features a 300-pallet controlled storage capacity designed to provide planned redundancies for the critical storage needs of the life-saving drug product.

PCI's director of facilities engineering, Russ Stevens, was the principle lead on the specialized project build. "We have decades of experience with controlled temperature infrastructure, both controlled temperature packaging and controlled temperature storage, across a broad range of environmental conditions," he said. "It is noteworthy that each temperature parameter provides for unique considerations in managing the conditions and mitigating risks. We engineered a multitude of installed mechanisms to assure continuity of supply, with redundancies in freezers and control units, as well as incorporating protections for infrastructure, fire, power, and many other factors, to the extent that we even took very specialized approaches to the engineering of the concrete foundation. It is truly cutting edge, to the degree that we are utilizing predictive technologies to help mitigate potential failure modes. It has been an amazing collaboration."

Brian Keesee, vice president and general manager global clinical operations and supply, PCI, said, "The new -40°C facility not only demonstrates the cold chain expertise of the team here at PCI, but also demonstrates our dedication to our clients and the lengths we go to accommodate the needs of their specialized medicines, no matter the challenge. This particular application had some distinctly unique requirements. Being trusted to help support such an important therapy for patients in need around the world, the team really embraced the opportunity and delivered a fantastic solution. The positive client feedback has been very gratifying, and validated our goal to provide the industry leading customer experience. It is also very inspiring to know we are helping in the battle to treat and hopefully eradicate this disease around the world."

Ajinomoto Althea Opens New Manufacturing Facility in San Diego

Ajinomoto Althea’s new ADC and highly potent fill and finish facility in San Diego supports early clinical phase through commercially approved programs.

The contract development and manufacturing organization (CDMO) has been headquartered in San Diego for 20 years and showed continued commitment to the city with its grand opening of the new manufacturing facility.

The facility is an antibody drug conjugate (ADC) and highly potent fill and finish facility near the company’s existing campus. It includes space for bioconjugation, formulation, purification, quality control, and sterile fill and finish.

The 57,000 square foot facility can accommodate early clinical phase through commercially approved programs.

Kevin Faluconer, the mayor of San Diego spoke at the grand opening along with the president of Ajinomoto, and the president and CEO of Althea. In his address, Faluconer said that the presence of Althea in San Diego has contributed to the economy and positively impacted the city. He furthered, “They [Althea] have attracted global partners like Ajinomoto to invest even more in the San Diego region. This is a story of success – one that is only going to get better and better with this new facility.”

Ajinomoto Althea in 2017 opened a GMP production suite in a commercial manufacturing facility also in San Diego. The CDMO also added an aseptic fill/finish line at the San Diego headquarters in 2017 in response to client concerns surrounding manufacturing costs.

Newage Completes Plant Expansion

The manufacturer of the AdvantaPure portfolio has built new cleanrooms ISO classes 7 and 8.

New cleanrooms were built in a US$10m investment plan.

NewAge Industries has completed a US$10 million expansion project at its headquarters in Pennsylvania (US). Located in Southampton, the company is an employee-owned business and the manufacturer of the AdvantaPure range of high purity tubing, hose, and single-use systems.

Following nearly two years of planning, preparation, construction and validation, team members at NewAge Industries/AdvantaPure are now using new cleanrooms to produce platinum-cured silicone tubing, molded components and single-use molded tubing assemblies. The products are manufactured for the biopharma, pharmaceutical and other clean application industries.

“This was a big undertaking,” commented Ken Baker, CEO of the Pennsylvania-based company. “We needed additional cleanrooms to manufacture more high-purity tubing and components to meet our customers’ needs, but we didn’t want to add a random room next to our other cleanrooms. This new area was designed and built from the ground up, with a vetted, product flow-through design for raw materials, extrusion, molding, quality inspection and packaging.”

The cleanrooms, ISO class 7 and 8, were built in existing space at the company’s headquarters in Southampton, just north of Philadelphia. The manufacturing suites and inspection areas total 23,000 sq. ft., with another 20,000 sq. ft. renovated for additional warehouse space.

NewAge invested US$10 million in the project. Engineering, design and construction was performed by AES Clean Technology, a company also based in Pennsylvania.

“Our intent was to move and validate our manufacturing equipment in phases to avoid any production stoppages or product shortages. We accomplished that, but we also decided to add more extrusion equipment and mold presses. This equipment expansion will help us meet our customers’ current and future product demands,” said Baker.

NewAge/AdvantaPure’s key customers who have inspected the new cleanrooms have approved them for production of their orders involving AdvantaSil platinum-cured silicone tubing and reinforced hose, Single-Use molded tubing assemblies and BioClosure container closure systems.

Newage Completes Plant Expansion for Additional Cleanroom Manufacturing Suites

Renovations encompass over 40,000 sq. ft.

The products are manufactured for the biopharm, pharmaceutical and other clean application industries.

The ISO Class 7 and 8 clean rooms were built in existing space at the company’s headquarters in Southampton, PA, just north of Philadelphia. The manufacturing suites and inspection areas total 23,000 square feet, with another 20,000 square feet renovated for additional warehouse space.

NewAge invested $10 million in the project. Engineering, design and construction was performed by AES Clean Technology Inc. of Montgomeryville, PA.

NewAge/AdvantaPure’s key customers who have inspected the new clean rooms have approved them for production of their orders involving AdvantaSil™ platinum-cured silicone tubing and reinforced hose, Single-Use molded tubing assemblies, and BioClosure^® container closure systems.

Point Loma Nazarene University Science Center, San Diego, Calif.

Cost: $22,830,000

Size: 36,000 sq. ft.

Project team: Carrier Johnson + CULTURE (architect), Rudolph and Sletten (general contractor), Spurlock Poirier Landscape Architects (landscape architect), Hope Amundson (structural engineer), MA Engineers (mechanical plumbing engineer), Michael Wall Engineering (electrical engineer), Michael Baker International (formerly RBF Consulting; civil engineer)

The Point Loma Nazarene University Science Center is one of the institution’s first major new building projects in decades. Built to accommodate a rapidly growing interdisciplinary science program, the three-story complex incorporates two buildings (Sator and Latter Halls) connected by an elevated walkway and overlooking the Pacific Ocean. Also incorporated is an outdoor terrace between the two buildings to be used year-round, taking advantage of San Diego’s temperate climate.

Sator Hall includes four lecture classrooms, 13 advanced labs for biology, chemistry and anatomy, serving the University’s mission to spark scientific discovery and the spirit of service. Wrapped in glass and smooth concrete, the new lab facilities are equipped and optimized for academic pursuits in biology and chemistry classes.

On the south-facing side, a series of metal screens feature laser-cut perforations in the shape of the Greek letters alpha and omega, symbols with both religious and scientific significance to allude to the institution’s dual mission of faith and academic pursuit. The screens create a cathedral-like effect of filtered light while providing shade and reducing solar heat gain.

The project has received LEED-NC Gold certification under the U.S. Green Building Council standard, and earned the Grand Award, Best Educational Project, from the PCBC Gold Nugget awards program.

Completion date: 2015

Ernest E. Tschannen Science Complex, California State University, Sacramento, California

Cost: $91.5 million

Size: 96,631 sq. ft.

Project team: CO Architects (architecture, interior design, programming and lab planning), Sundt Construction (general contractor), P2S Inc. (MEP engineer), Buehler & Buehler Structural Engineers (structural engineer), Cunningham Engineering (civil engineer and landscape architecture), KGM Architectural Lighting (lighting), Mei Wu Acoustics (acoustical), CPP (wind engineering and air quality), Lerch Bates (vertical transportation), Atelier Ten (energy and environmental design consultant), Jensen Hughes (code consulting)

The Ernest E. Tschannen Science Complex at California State University, Sacramento, designed by CO Architects, will feature a planetarium with a 2,500 sq. ft. dome to offer a high-tech environment for students to learn about astronomy and the night sky.

The Ernest E. Tschannen Science Complex at California State University, Sacramento, will feature a state-of-the-art, energy-efficient, light-filled science facility providing teaching and research laboratories for the College of Natural Sciences and Mathematics. Targeting LEED Gold certification, the new five-story complex will provide indoor and outdoor student collaboration spaces and terraces, as well as teaching and research laboratories, learning studios, classrooms, a rooftop observatory and a 120-seat planetarium.

CO Architects’ façade design pays homage to the nearby American River; the concept relates to the rippling effect created when a stone is thrown into water. The location of the planetarium at the building’s inward inflection point represents the stone’s impact in the river, while the patterned window system radiates outward to emulate the ripples formed. Polished, dark concrete and spandrel glass, along with vertical and horizontal concrete bands and metal sunshades, additionally signify elements of nature.

Instructional laboratories will have large expanses of glass adjacent to public corridors in order to promote “science on display” and connect students and faculty. These corridors branch out toward the east and west from central lobbies on each floor. Filled with natural light during the day and a soft glow at night, the open lobbies will act as the heart of the building, where students can collaborate and study in specially designed spaces. An observatory accessible from the building’s rooftop will feature a retractable roof and two telescopes to serve as a location for viewing the cosmos. The planetarium has a 2,500 sq. ft. dome offering a high-tech environment for students to learn about astronomy and the night sky. The integrated landscape, featuring a man-made earth berm and native plantings, will provide opportunities for biologists and botanists to experiment and teach outside their labs.

Completion date: June 2019

ViroMed Secures DNA Production Facility in the U.S.

ViroMed has acquired a plasmid DNA production facility in San Diego, CA from Vical Incorporated. With ViroMed's first Phase III clinical trial of its lead product VM202 (donaperminogene seltoplasmid) for painful diabetic peripheral neuropathy (PDPN) nearing its completion, ViroMed, in joint venture partnership with a private equity investment firm, acquired the GMP ready facility that has been until recently a production site for clinical studies including phase IIIs in the U.S. of DNA-based investigational new drugs.

With CMC (chemistry, manufacturing, and controls) being an important part of the Biologics License Application process, and often the reason for delay in market approval for a new drug in the U.S., the acquisition comes as a significant milestone for a company conducting late-stage development. Production is considered particularly an important issue in the case of plasmid DNA-based gene medicines as they have never been approved and commercialized as a drug for humans. Securing a manufacturing site is also expected to be a boost in the company's bargaining power for potential out-licensing and marketing partnership deals.

The facility in San Diego is equipped with a 500 L fermenter, cell culture lab and QC test lab, and has extra space for future expansion, making it an ideal site for both biopharmaceutical R&D and commercial-scale plasmid DNA production. With the aim to initiate first test runs within this year and GMP production in the first half of 2019, the company is securing key personnel necessary for the facility operation.

"We are very excited to secure a plasmid DNA production facility, which has been a major issue for the company," said Sunyoung Kim, chief executive officer, ViroMed. "Through the acquisition, we expect to not only maximize the value of VM202 but also create additional business opportunities as we move forward. Taking a step further from an R&D-focused company, it is our vision to become a biopharmaceutical company in our own right that covers all stages of new drug development including R&D, production and quality management. ViroMed is currently the only company conducting Phase IIIs in the U.S. involving plasmid DNA, and we are pleased to be able to demonstrate once again that ViroMed is a global leader in the field of plasmid DNA gene therapy."

FDA Approves Grifols' Facility for Production of Recombinant Proteins

New facility, equipment, and automation systems ensure reliable production of antigens for blood supply safety

Grifols recently received approval from the U.S. FDA to relocate existing immunodiagnostic manufacturing operations to a new consolidated manufacturing facility (CMF) in Emeryville, CA.

This first submission enables commercial good manufacturing practices (GMP) fermentation, purification, and bulk fill operations in the facility and the production of one recombinant HCV antigen. Additional submissions to the FDA are planned to relocate the production of other licensed recombinant protein products. The transition is targeted for completion in mid-2019, pending the FDA approvals for the licensed antigens. Once the transition is complete, Grifols will have transferred 21 products to the new facility.

"The FDA approval is a major milestone for this multi-year project," said Ramon Biosca, vice president and general manager, Grifols Diagnostic Solutions. "The new facility is a significant investment in our manufacturing organization and will ensure reliable, long-term production of current and future products."

As part of Grifols' investment for future growth, the company designed, built, and validated the $80 million, state-of-the-art, biological manufacturing facility in the San Francisco Bay Area. The new facility has 25,000 square feet of GMP manufacturing space, including two fermentation suites for E. coli and yeast processes, three purification suites, and a bulk fill area. Automation systems provide control of manufacturing processes and a central data historian monitors and stores all data generated in the facility, including the warehouse and utility systems.

In addition, Grifols has recently begun an engineering project to convert the 9,000 square foot expansion space within CMF into cell culture and purification suites for production of recombinant proteins expressed in mammalian cells. The facility will use disposable technology and is expected to be complete in late 2019.

The new consolidated manufacturing facility, along with the development capabilities in the laboratories and pilot plant, provides a range of process scale and flexibility for the current portfolio of products and the R&D pipeline, as well as supports development and manufacturing services to third parties for recombinant protein production.

"The Emeryville campus has a long history of recombinant protein production, beginning with Chiron in the 1980s," said Mr. Biosca. "With this tradition of technical expertise and the new facility, Grifols is well equipped to provide contract development and manufacturing services to our current and future customers."

Astro Pak Opens Florida Facility

Located outside the Kennedy Space Center, the facility houses an ISO 7 cleanroom and accompanying ISO 6 lab.

Astro Pak, the American high purity, passivation and precision cleaning services company, has opened its state-of-the-art facility following renovation, located just outside of the Kennedy Space Center (KSC) in Florida, US.

The facility houses an ISO 7 cleanroom and accompanying ISO 6 lab. These facilities are further augmented by large aqueous processing tanks, a preclean area with multiple work stations, ultrasonic units, as well as hydrostatic, hydraulic and pneumatic testing capabilities.

The facility is also supported by Asotro Pak's brand new cleanroom trailer, which allows for onsite support in addition to the in house services.

"The new facility offers greatly expanded capabilities enabling more services to be offered to our local and regional customers," said Jonathan Hopkins, General Manager of Chemko.

Amgen’s New Bio-manufacturing Plant, Rhode Island

US-based biopharmaceutical company Amgen is developing a bio-manufacturing facility at its campus in West Greenwich, Rhode Island, US.

A ground-breaking ceremony for the new plant took place in July 2018. It will manufacture products for the US and international markets by incorporating the company’s next-generation bio-manufacturing capabilities and state-of-the-art technologies.

Amgen has invested $200m in the new plant, which is expected to be fully operational in 2022. Once complete, it will create more than 150 highly-skilled manufacturing jobs.

The project is expected to generate more than $3.7m in net revenue to the Rhode Island state over a 12-year commitment period.

Amgen’s next-generation bio-manufacturing facility is being built on its 75-acre campus in West Greenwich, Rhode Island.

This area was selected due to the availability of a skilled workforce, potential state incentives and the success of Amgen’s existing West Greenwich manufacturing facility.

The new bio-manufacturing facility will cover an area of 120,000ft². It will manufacture various biologic therapeutic medicines.

It is claimed that the project’s novel technologies will allow it to be built in half the time and operating cost of a standard plant. It is designed to offer greater flexibility, speed and efficiency to manufacture multiple medicines simultaneously.

The smaller manufacturing footprint also offers environmental benefits such as reduced water consumption and energy, as well as lower levels of carbon emissions.

Amgen has received $2.2m in tax credits from the Board of the Rhode Island Commerce Corporation through the Rebuild Rhode Island tax credit program. A $600,000 a year tax credit will also be available through the Qualified Jobs Incentive Act for a ten-year period.

The company will also receive $1.25m for performance metrics and a tax exemption on construction materials and furnishings.

Amgen’s current facility in Rhode Island was licensed by the US Food and Drug Administration (FDA) in 2005. The facility features one of the world’s biggest manufacturing facilities for mammalian cell protein, and develops commercial and clinical bulk drug substances.

The company invested more than $1.5bn on the existing campus, which includes 500,000ft² of manufacturing, administrative and laboratory space.

The existing campus in Rhode Island has more than 625 employees.

Amgen:

Based in the US, Amgen is a biotechnology company focused on the discovery and development of innovative human therapeutics. The company specializes in the manufacture of drugs for key therapeutic areas such as cardiovascular, oncology, bone health, neuroscience and nephrology.

Amgen has a global presence in more than 100 countries and employs more than 20,000 staff across all its facilities worldwide.

Catalent Completes Juniper Merger To ‘Expand And Strengthen’ Oral Dose Manufacturing

Catalent announced the successful completion of its tender offer in a US Securities and Exchange Commission (SEC) filing. The contract development and manufacturing organization (CDMO) paid approximately $130m in cash for Juniper’s stock, priced at $11.50 per share.

“The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions and clinical-scale oral dose manufacturing, and complements its integrated global clinical and commercial supply network,” said Catalent in the filing.

“In addition, as a result of the merger, Juniper will become a wholly owned subsidiary of [Catalent] and the shares of common stock of Juniper will cease to be traded on the NASDAQ Global Select Market,” the firm added.

Catalent announced plans to acquire Juniper mid-2018, which it said would provide a new European hub and attract a larger share of early-phase development business. The CDMO will also incorporate Juniper’s Nottingham, UK-based Pharma Services business into its network.

As Juniper’s parent company, Catalent will continue to supply Crinone (progesterone gel), marketed by Merck KGaA outside the US.

The merger marks Catalent’s latest investment in development and manufacturing services. In 2016, the CDMO acquired Pharmatek Laboratories in San Diego, US, and in 2017, acquired Cook Pharmica to expand its biologics, cell culture manufacturing, and packaging capabilities.

Earlier this year, the announced plans were to invest in its Somerset, NJ, facility, and build a center of excellent on America’s East Coast.

In April 2018, Catalent increased its clinical packaging and storage capacity in Philadelphia, PA, with a $5.5m site expansion.

Trans-Hit Bio Signs Commercial Agreement with Arizona Hospital

Trans-Hit Bio, a worldwide CRO, has signed a commercial agreement with the biobank of Arizona’s Maricopa Integrated Health System.

An agreement between Trans-Hit Bio (THB), a contract research organization (CRO) specializing in human biospecimens, and Maricopa Integrated Health System (MIHS) was signed to provide THB with access to MIHS’ biospecimen collection.

Per the agreement, THB will promote MIHS capabilities in procuring collections from clinical centers.

Vanessa Tumilasci, project director for Trans-Hit Bio said, that generally, community medical centers like MIHS don’t have the resources or infrastructure to support biospecimen collection, so many specimens are discarded, and the few centers that have the infrastructure lack visibility.

“Trans-Hit Bio, with its portfolio of researchers, is able to facilitate the provision of these valuable biospecimens to biopharma organizations who often have difficulty in identifying sources for ethically-collected high-quality samples with comprehensive associated clinical data,” said Tumilasci.

The agreement between MIHS and THB is limited to interactions solely within the biopharma community as facilitated by THB. MIHS can still provide samples to its in-house and academic researchers, as well as to industry-sponsored clinical trials.

“This agreement strengthens Trans-Hit Bio’s capacity for providing well-annotated samples from the general population in the US. This is an approach we have adopted successfully in many other countries and which we are confident will be successful with other organizations in the near future,” said Tumilasci.

She further explained that this agreement is not about commercialization but rather helping the biopharmaceutical industry gain access to clinical samples that can be critical to diagnostic development.

There has been a growing emphasis on biobanking. It is critical to enable genomic, proteomics, and immune modulation which are all needed for the research and development of new diagnostic and curative therapies. Biobanking also plays a role in personalized medicine development.

Tumilasci said that more than 80% of the general American population is treated at community medical centers and biospecimens collected at those centers, like MIHS, can offer benefits to the research community, as this covers a more diverse population of human biospecimens.

MIHS is Arizona’s only public teaching hospital and consists of Maricopa Medical Center, McDowell Healthcare Center, the Refugee Women’s Health Clinic, the Arizona Children’s Center, two behavioral health centers and 13 family health centers.

Charles River Expects to Double Size in 5 Years

Fueled by increasing investments from biotech, Charles River expects to double the size of its business over the next five years – organically and through M&A – to become a ‘more responsive partner,’ says CEO.

James Foster, Charles River CEO, said the company’s growth is indicative of “an extremely healthy market environment,” citing biotech funding which is slated to reach the second highest level on record.

“Both large and small clients are intensifying investments in their pipelines – creating new business opportunities for Charles River,” he added on the company’s second quarter 2018 earnings.

The Wilmington, MA-headquartered company reported a revenue of $585.3m, marking a 24.8% increase over last year. Foster said the growth was broad across the company’s spectrum of clients, “with both biotech and global biopharma clients contributing substantially to the increase as well as academic institutions.”

Through the end of the year, Foster said revenue will have nearly doubled since 2013, including acquisitions. Additionally, its employee base has increased by approximately 75% over the last five years. The company is hiring significantly across multiple geographies, Foster added – and has increased hourly wages in certain businesses, predominantly in North America, the UK, and China.

“We expect these investments to continue as we anticipate doubling the size of the company again in the next five years,” explained Foster. As part of this, he noted that the business must be “flexibly scaled” to respond to the evolving market.

Subsequently, Charles River has adopted a new operating model to create a more “agile” organization; one that it says is more client-centric with fewer layers, “driving the decision-making to the point of impact.”

In line with the changes, the company eliminated the chief operating officer role. Davide Molho, who previously filled this position, has left the company “to pursue other interests.”

“The less top-down decisions are made, and the more, as I said before, closer to the decisions as possible, I think the better off we are,” explained Foster.

CFO David Smith said strategic acquisitions remain the company’s top priority for capital allocation, followed by debt repayment.

Regarding 2018 guidance, Charles River increased its revenue growth outlook to a range of 19% to 21% on a reported basis. Smith said this reflects strong demand trends and a slightly higher contribution from acquisitions, primarily MPI Research – which, after being acquired earlier this year, is on track to deliver $13m to $16m of operational synergies by the end of 2019.

MPI has available capacity and Foster said it will continue to bring “small tranches of capacity online” across its global safety assessment network “to accommodate robust client demand.”

Foster also noted that the pipeline of acquisition candidates across its portfolio remains robust. “Based on our second quarter performance and our outlook for the remainder of the year, we believe that the pace of demand will accelerate,” he added.

For the research models and research model services (RMS) segment, revenue was $130.4m. Foster said the growth rate improved for a second consecutive quarter, with China delivering “another outstanding performance,” for research models.

“Growth accelerated as the new Shanghai facility continued to ramp up to full capacity, and we won new business in China because of our expanded footprint and high-quality models,” said Foster.

“With year-to-date revenue of slightly less than 10% of our total RMS revenue, China is becoming a larger contributor to the RMS segment's growth rate,” he added.

Client use of technologies such as CRISPR also is driving increased demand for the company’s genetically engineered animals models and services (GEMS) business, Foster explained.

Models used by the discovery and safety assessment (DSA) segment represented more than 5% of its total global research model volume to date, “which was more than twice the volume of our largest RMS client,” said Foster. “This underscores the importance of our research model business.”

Looking to future growth, Foster said it will be continuous, with additional spaces in the Shanghai market potentially needed and currently being investigated.

“We, for sure, will need additional capacity west and south,” he said. “It's a gigantic country and – so, big research centers, and a lot of money being pumped into the Chinese life sciences arena by the government,” Foster said.

If Chinese companies want to “play on the international scene and sell their drugs internationally,” Foster said, “they're going to have to use higher-quality animals to do their basic research.”

“There's maybe some M&A opportunities there, which we'll obviously pursue if we can, if they make sense for us. But we are out and about literally right now looking for additional space, so stay tuned,” he added.

Revenue for the manufacturing support segment was $108.5m – with significant improvement from the biologics business at an organic revenue growth above 10%. Charles River divested its small-molecule CDMO business last year.

“The number of biologic and biosimilar drugs in development has been growing at double-digit rates, which continues to drive the demand for our services and the need for new capacity,” Foster explained, noting global expansions and plans to open a new facility in Pennsylvania.

Once open, the company intends to transition certain laboratory operations to the new Pennsylvania site “at a measured pace,” which will continue through most of 2019.

“There will be modest pressure on the manufacturing segment's operating margin through the transition process, but we believe capacity expansion is critical to accommodate client demand, which is expected to be robust for the foreseeable future,” Foster added.

Foster said Charles River intends to stay in the non-clinical arena. “We have about a $15bn market,” he added, “So, it's a big market, one where we have leading market shares in virtually everything we do and opportunities to enhance those shares.”

Though also investing in organic growth Foster commented that the M&A pipeline “is quite diverse and quite robust … There's a lot of assets out there,” he said, noting that multiple conversations are ongoing.

“We have a vision and a view towards how we will continue to expand and enhance our portfolio, not just to be bigger, but to be more responsive partner,” Foster added. “So, I would say that fill in some very subtle areas where we are under scale and expand some areas where we have significant scale but need to be larger.”

Tracelink Participates in Serialization Pilot in Ireland

TraceLink, a company specializing in serialization, joined the Irish Medicines Verification Organization (IMVO) pilot program before EU FMD deadline.

The IMVO, a not-for-profit organization created to manage the Irish Medicines Verification System (IMVS), launched a pilot serialization program to connect hospitals, pharmacies, and clinics to the IMVS. TraceLink will join this pilot as part of an effort to protect patients from falsified medicines through serialization practices.

Leonie Clarke, IMVO project manager noted, “It’s not a pilot in the classical sense of the word. One thinks of a pilot as a testing system before you release the system live. The system that’s being tested is fully live and fully functioning. So, it’s really a trial run of the whole thing before we go into the stage where it will be mandatory next year.”

The deadline for the EU FMD implementation regulations is February 9th, 2019. We reported that many companies are taking measures to work towards preparing for this deadline, with TraceLink developing technology platforms to ease the process.

TraceLink’s Android and iPhone applications and a Bluetooth scanner to collect barcode data will be used in the pilot program. These applications aim to comply with verification and decommissioning requirements under the European Union Falsified Medicines Directive (EU FMD).

Graham Smith, general manager of healthcare and pharmacy at TraceLink remarked, “TraceLink’s pharmacy application processes different transactions from the pharmacy and displays the response from the National System for the pharmacist.”

This response enables the pharmacy to be compliant with the requirements of the FMD. Smith further explained that the pharmacy mobile application is for both retail and hospital pharmacies.

Clarke said that they did not specifically pick TraceLink for the pilot but opened the program up to any IT software providers who wanted to provide assistance. She furthered that the IMVO is “delighted” to work with TraceLink and all the software providers on board with the program.

She remarked that “it’s very encouraging from our perspective that there are a number of providers.”

The key objective of this pilot is learning – the IMVO wants to learn any changes that they need to make to its systems or to make it as easy as possible for IT providers to come on board, according to Clarke.

EU FMD is an authentication system and according to Clarke implementing serialization programs for the system has been complex but necessary.

“At the end of the day, we’re making sure when patients go into pharmacies or hospitals, they’re not getting falsified medicine. I think that’s a level of reassurance that’s important for patients and something we’ll be talking about as we move towards February 2019,” said Clarke.

CSL’s Illinois Operation Expansion

CSL has announced that its full year results saw the company’s net profit increase by 30%, in the same year that it announced plans for a 1.8m-square-foot expansion to its Illinois site.

CSL, an Australian-based biotech manufacturer, revealed in its full year results that it had achieved a post-tax net profit of $1.7bn ($2.34bn AUD).

The press release regarding its financials for the full year-to-date also suggested that it expects growth of 10-14% for the year to come.

The full details revealed that the company’s US subsidiary, CSL Behring, was responsible for the lion’s share of the sales generated by the company ($6.6bn in sales against total sales of $7.5bn). In addition, this part of the business grew by 11%.

CEO, Paul Perreault, also pointed towards the launch of several products, including Haegarda and Idelvion, as part of the reason the company has seen such growth.

In addition, he noted that it had opened 27 plasma collection centers in the US, as part of an expansion plan to bolster its CSL Plasma division – a subdivision of CSL Behring.

The success of its CSL Behring unit explains why the company felt secure in an announcing a massive 1.8m-square-foot expansion to its campus in Kankakee, Illinois.

The plans for the site, announced earlier this year, could take as long as 12 years to complete.

How much the company is investing in the development was not released but it is currently completing construction of its ‘CSL South’ building, a space of 300,000-square-foot, which cost $240m.

The company is also set to further invest in a 74-acre site in Bourbonnais Township, located next to its current campus, which has already been purchased but with no announcement made to the public regarding its plans for the site.

REST OF WORLD

WuXi Biologics' Facility in Dundalk, Ireland

The CDMO has broken ground on its first site outside of China – a €325m single-use manufacturing facility in County Louth, Ireland.

Construction has commenced at WuXi Biologics’ Irish facility, where the contract development and manufacturing organization (CDMO) will make biologic drugs for commercial production.

The 26-hectare campus will house 48,000L fed-batch and 6,000L perfusion bioreactor capacity, with single-use and continuous bioprocessing capabilities.

Supported by the Republic of Ireland’s Industrial Development Authority (IDA), the €325m ($390m) project is located on the government agency’s greenfield site in Mullagharlin, Dundalk.

According to WuXi Biologics CEO Chris Chen, Ireland’s European Union (EU) membership makes it an attractive option for investment, as the UK prepares to leave the union.

Ireland’s proximity to mainland Europe provides the CDMO “access to [the] EU market,” he said in May of this year.

While the Dundalk facility marks WuXi Biologics’ first outside of China, the firm has plans to build global facilities in Singapore and the US.

The CDMO is also expanding its site network within China. Last month, WuXi Biologics broke ground on a 1.6 million-square-foot Biologics Innovation Center in Shanghai, as well as on a $240m manufacturing site near Beijing.

Sterigenics Expands European Capacity with New Gamma Sterilizations Facility

Sterigenics has announced that it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK.

The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global Health™.

Scheduled for completion in Q4 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000ft2 facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire.

President of Sterigenics Philip Macnabb said: “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health.

“We continue to invest in our global network to meet our customers’ growing demand for gamma irradiation capacity as a critical step in their product development processes. Our new Markham Vale facility will strengthen our ability to serve our European customers, particularly in the MedTech and pharmaceutical fields, and help them innovate with success.”

The new facility will provide routine gamma, GammaStat® rapid processing and process validation, as well as laboratory testing services in nearby Somercotes through its Nelson Labs business. The facility will expand Sterigenics’ total gamma irradiation capacity in Europe, adding to existing gamma facilities located in Belgium and Italy.

Director of UK Operations Adrian Wye said: “Our Markham Vale North facility is strategically located to serve the needs of our European customers.

“Its prime location at the heart of the UK’s motorway network will provide an optimum location for their supply chain logistics. And our facility’s high-tech capabilities will deliver the turnaround times necessary to distribute their products to market quickly.”

To address the growing need for sterilization in many parts of the world, Sterigenics is making significant investments in technology to expand both gamma and ethylene oxide (EtO) sterilization capacity throughout its global network.

In August 2017, it completed a major expansion of its Forth Worth facility, adding gamma capacity and increasing total sterilization throughput. In June 2017, it completed a project that significantly increased throughput at its operation in West Memphis, Arkansas, and in 2015, it opened a significant expansion in Gurnee, Illinois. In addition, Sterigenics has recently expanded its EtO facilities in California, Costa Rica, and Germany. Further announcements are expected in the near future.

About Sotera Health:

Sortera Health is one of the world’s leading, fully integrated protectors of global health. With 500 years of combined scientific expertise, the company ensures the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue and food industries. Sotera Health operates 61 facilities in 13 countries.

The company has more than 2,600 employees globally and touches the lives of more than 180 million people around the world each year. It serves more than 5,000 customers worldwide, including 75 of the top 100 medical device manufacturers.

Sotera Health goes to market through Nelson Labs™, Nordion and Sterigenics with the mission of ensuring the safety of healthcare each and every day. Nelson Labs offers microbiological and analytical testing and expert advisory services to assist customers in developing and maintaining sterilization solutions in medical devices, tissue/implantable products, and the pharmaceutical and biologics fields.

Nordion is the world’s largest provider of Cobalt-60 used in the gamma sterilization process. Sterigenics provides comprehensive contract sterilization and ionization solutions for the medical device, pharmaceutical, food safety and high-performance materials industries.

AstraZeneca, Cancer Research UK Launch Functional Genomics Centre

AstraZeneca announced a new collaboration with Cancer Research UK to launch a Centre of excellence in genetic screening, cancer modeling and big data processing aimed at accelerating the discovery of new cancer medicines. The Functional Genomics Centre will further develop CRISPR technology to better understand the biology of cancer, creating biological models that may be more reflective of human disease, and advancing computational approaches to better analyze big datasets. These approaches are designed to inform new druggable targets in oncology by using clinical insights to better understand tumor disease and resistance mechanisms.

Functional genomics aims to understand the complex relationship between genetic changes happening within DNA and how these translate to cellular changes in disease. Knowing the functional genomic drivers of disease enables scientists to more accurately select the right drug targets and increases the probability of success in the clinic.

“The best science doesn’t happen in isolation which is why AstraZeneca is committed to advancing innovative science through collaboration,” Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development, AstraZeneca, said. “This new Centre of excellence with Cancer Research UK will combine our expertise in functional genomics and CRISPR technology to identify new biological pathways driving disease and will accelerate the development of new cancer medicines for patients.”

“We’re delighted to collaborate with AstraZeneca on this exciting new initiative which will give leading Cancer Research UK scientists and our alliance partners access to the latest in CRISPR technology,” Dr. Iain Foulkes, Cancer Research UK’s Executive Director of Research and Innovation, said. “As we move into an era of personalized medicine, we’ve reached a turning point in our ability to harness powerful technologies in the pursuit of targeted cancer therapies. We hope that this will translate into urgently needed new therapies for patients with hard to treat cancers such as lung, pancreatic, oesophageal and brain tumors.”

The Functional Genomics Centre will be located at the Milner Therapeutics Institute at the University of Cambridge. AstraZeneca and Cancer Research UK will have independent use of the Centre’s facilities, and their scientists will work alongside each other to facilitate collaboration, technical innovation and scientific progress.

At the Centre, scientists will have access to the next generation of CRISPR libraries for silencing or activating every gene in the genome, accessed through an extension of the existing collaboration between AstraZeneca and the Wellcome Sanger Institute. This collaboration includes access to the Wellcome Sanger Institute’s most recent versions of human and mouse genome-wide CRISPR/Cas9 knockout libraries, as well as Cas9 and dual gRNA expression vectors. This extends the application of CRISPR technology with vectors, providing enhanced sensitivity and specificity in gene editing, leading to easier targeting and identification.

A separate collaboration between AstraZeneca and the California-based Innovative Genomics Institute (IGI) will aim to use CRISPR to uncover genes and disease pathway mechanisms involved in DNA Damage Response (DDR), a key process involved in many cancers and one of AstraZeneca’s four key platforms in oncology. Research will focus on identifying potential therapeutic strategies for DDR inhibitors, including combinations, in oncology.

Lonza to Establish Biomanufacturing Base in China Using GE Healthcare Solution

Lonza announces an agreement with GE Healthcare under which GE Healthcare will deliver a biologics facility to Lonza in Guangzhou (CN)

As the facility is part of a larger biomanufacturing initiative between GE Healthcare and Guangzhou Development District (GDD), the agreement will be finalized when contracts have been signed with the GDD.

Lonza will sign a memorandum of understanding with the GDD to take the project forward. The new facility will give Lonza Pharma & Biotech a strategic base in China to respond to growing demand for high-quality CDMO services in the country.

By working with GE Healthcare to develop the new facility, based on the KUBio platform, an off-the-shelf biologics factory, Lonza intends to offer its suite of antibody development services and manufacture GMP-certified batches by 2020.

The two companies will work closely on the design of the 182,920 sq. ft. (17,000 m2) site, which will include 69,940 sq. ft. (6500 m2) of lab space and one KUBio facility.

The labs will house Lonza’s proprietary platforms for cell-line construction, including the GS Gene Expression System, as well as process development, cell banking and pilot labs.

The KUBio unit will enable small-scale GMP manufacturing equipped with GE Healthcare’s single-use biomanufacturing technologies, including 1000 and 2000 L bioreactors, combined with Lonza’s automation platforms for clinical and early commercial supply.

“This partnership is the ideal way for Lonza to bring our expertise and technology to China,” said Marc Funk, COO Lonza Pharma & Biotech.

“The combination of a strong and experienced technology provider with a long history in China, together with a dynamic regional authority, means that we can rapidly offer services to customers and ultimately get innovative therapies to patients more quickly.”

GE Healthcare is working with the GDD to support large-scale manufacturing of biopharmaceuticals in China.

“With Lonza coming on site, a hub of biotech is truly taking shape,” said Emmanuel Ligner, President and CEO, GE Healthcare Life Sciences. “This agreement is yet another step in realizing our vision of enabling and supporting manufacturers of all sizes to quickly deploy capacity and meet increasing customer demand for biologics.”

The facility in China will extend Lonza Pharma & Biotech’s global biologics network that provides development and manufacturing services from gene through IND and BLA to mature commercial supply. In addition to the new Chinese site, the network comprises small-, mid- and large-scale assets in Switzerland, the United States, the UK, Spain and Singapore.

Lonza plans to hire and train more than 160 staff, and the new site will benefit from the company’s global standards of technological and operational excellence.

With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza will now be able to offer the same high standards in China as it does elsewhere.

China has been historically underserved by biologics, but demand for antibody therapies is expected to grow significantly during the coming years.

A strong scientific base and commercial instruments put into place by the Chinese authorities are encouraging their domestic companies developing innovative therapies for the global market, as well as multinationals with manufacturing requirements in the country.

In particular, national rollout of the Marketing Authorizations Holder scheme by 2019 paves the way for dedicated CDMO services in China.

SGS to Expand Bioanalytical Testing Capabilities in France

SGS is investing €3.5 million to undertake a two-phase expansion project at its laboratory in Poitiers, France, to implement a 50% increase in bioanalytical capabilities at the site by 2020

The initial phase of the project was completed in November 2018, with the delivery of a new, 1614 sq. ft. (150 m2) immunoassay laboratory, equipped with eight instruments (MSD, ELISA, Luminex, Ella) and with the capacity to employ 20 analysts.

The second phase of the expansion will commence with the construction of a new, 8,608 sq. ft. (800 m2) building, housing both a new laboratory and office space, and the renovation of the existing laboratory at the site.

Alongside the renovation works will be the introduction of a new electronic laboratory notebook system across the entire facility, as well as upgrades to the site's quality management system and sample automation capabilities.

Recruitment of new staff, which has seen an increase of more than 25% during the past 2, is set to continue and will further accelerate by Q3 2019.

Alain Renoux, Laboratory Director, said: "This major investment in equipment, facilities and expert staff will significantly increase the capabilities at the site to match increasing demand and shorten processes for our pharmaceutical clients. SGS has a commitment to offer a global presence with a center of excellence model, and it is through investment in both the state-of-the-art facilities and staff that we can meet this ambition."

SGS's Poitiers laboratory currently offers a full range of bioanalytical services for both small molecules and biologics, including mass spectrometry, immunoassays and cell-based assays.

The expansion at the site follows SGS's recent announcements of investment and expansion of services at its Lincolnshire (IL, USA), Geneva and Mississauga (Canada) laboratories.

Novartis Relocates UK Headquarters to London

Novartis has announced plans to move its UK headquarters to an ‘emerging life sciences cluster’ in West London, 50 minutes’ drive from its current location in Surrey.

The WestWorks in London’s White City, located on a 1.9 million-square-foot campus, will house Novartis’ UK headquarters from January 2020.

According to a company spokesperson, the new headquarters represents a “multi-million-pound investment” that will bring four business units together: Pharmaceuticals, oncology, global drug development, and Novartis business services.

“We are now working with employees to help shape how this move will work for, and the new office used by, them,” we were told.

White City is building a reputation as a growing life sciences cluster, the firm continued.

“White City is quickly becoming one of the UK’s life sciences and technology districts, and the ethos of The WestWorks campus complements how we work to deliver on our strategy to reimagine medicine,” said Haseeb Ahmad, Novartis UK country president in a statement.

Imperial College London’s new research and innovation campus is also located at White City, which according to the university’s VP of innovation, David Gann, could lead to public-private collaborations.

“Novartis is a natural fit for White City’s booming life sciences ecosystem, and we hope that this move will pave the way to new collaborations and partnerships to enhance our work in this area,” he said.

The HQ relocation marks Novartis’ second of the year, after announcing plans to move the global headquarters of its eye care division, Alcon, from the US to Switzerland. Novartis plans to spin-off Alcon to become a standalone company.

In other restructuring news, earlier this year Novartis divested its US generic oral solids and dermatology businesses to Aurobindo Pharma US, sold its stake of a joint healthcare venture to partner GlaxoSmithKline, and its injectable medicines site and development Centre in Boucherville, Canada, to Avara Pharmaceutical Services. In July, Novartis discontinued its antibiotics R&D programs.

Casi to Create Manufacturing Facility in China

The US company will complete a ‘large-scale’ manufacturing facility to support production in the next three to five years.

Casi Pharmaceuticals continues its push into the Chinese market with plans to develop a manufacturing facility in Jiangsu Province, China.

The firm has already in-licensed three US Food and Drug Administration (FDA) approved products from Spectrum Pharmaceuticals specifically for China. It also holds a Beijing-based subsidiary and R&D operations in the country.

A spokesperson for Casi said the facility will take three to five years to complete construction work, receive FDA approval and then scale up production.

“The project will be completed in phases. For the first phase, we expect to file with the FDA for changing manufacturing site approvals of our first key ANDA (abbreviated new drug application) product in two years,” the spokesperson continued.

Construction of the facility will begin in mid-2019 and the firm said in a statement that it will be “a key asset supporting Casi’s growth and commercialization plans with further agreements to be finalized”.

In terms of the cost of the facility, the company will invest $21m (€18.4m) and will receive $20m from an undisclosed “joint venture partner”, the spokesperson said.

It will also invest several ANDA products into the joint venture, which the company values at, or above, $30m.

The spokesperson was unable to confirm which products will be produced at the site but said that the company is “evaluating the market potential” of 30 ANDA products to be produced at the site – with China and the US the intended markets.

At the beginning of the year, Casi acquired a portfolio of 25 ANDA products from Sandoz, a subsidiary of Novartis, with the intention of producing these assets for the Chinese market.

Catalent Expands Clinical Packaging Capabilities in Shanghai, China

Catalent Pharma Solutions announced that work to expand its primary packaging capabilities at its clinical facility in Shanghai, China has reached the commissioning stage and is scheduled to be completed soon.

The expansion includes a new automated, high-speed bottling line suitable for capsule and tablet products. The line will increase packaging capacity by up to 100 bottles per minute, and provides for quick and easy changeover, essential for clinical-scale production.

“Globally, almost 2,000 industry sponsored clinical trials were conducted in the last two years,” said Roel de Nobel, Catalent’s Vice President, Global Operations, Clinical Supply Services. “Our continued investment in Asia Pacific reflects the importance of, and the continued growth of clinical trials in Asia, driving the need for in-region packaging services.”

This expansion follows the announcement that work is underway to open a new clinical facility outside of Shanghai’s free trade zone (FTZ). The new facility is expected to be completed in early 2019 and will join the company’s existing three clinical packaging facilities in the Asia Pacific region, namely in Shanghai’s Waigaoqiao FTZ, Singapore and Kakegawa, Japan. In addition to its primary packaging capabilities, the company offers comprehensive clinical supply solutions in the region including clinical supply management, comparator sourcing, FastChain demand led supply, secondary packaging, storage and global distribution and clinical returns and destruction.

GE to Open Fiber-Based Chromatography Facility in UK

The Stevenage facility will produce a fiber-based purification platform for the manufacture of biopharmaceuticals, gene therapies and viral vectors.

GE Healthcare Life Sciences will open the manufacturing site in the Stevenage Bioscience Catalyst Open Innovation Campus, approximately 50km north of London, in the first half of 2019.

The facility houses 3,013 sq. ft. (280m²) of cleanroom space and accommodates 20 employees. Fiber-based purification products will be prepared in Stevenage before being transferred to the firm’s manufacturing plant in Cardiff, Wales, for additional processing.

GE incorporated the fiber-based platform into its chromatography portfolio in November 2017, when the US-headquartered firm acquired Stevenage-based Puridify.

The technology is comprised of a nanofiber-based material to which ligands are attached to activate the platform for purification.

According to GE, the platform’s novel structure facilitates uniform purification at all scales: “This, in combination with its macroporosity, also gives it strong potential as an enabling technology for the purification of next-generation macromolecular biotherapeutics such as gene therapies, viral vectors and fusion proteins.”

Olivier Loeillot, SVP of GE’s bioprocess division, said that fiber-based chromatography has the potential to significantly improve speed, flexibility and robustness during purification.

“The fiber-based chromatography technology manufactured in Stevenage is complementary to GE Healthcare’s range of bioprocess purification products and, once commercialized, will be fully integrated into our offering,” he added.

The firm did not disclose cost comparisons between fiber-based chromatography and Protein A – an effective and notoriously expensive purification product.

Sartorius Announces Plans for Life Science Factory

Sartorius announced plans to promote startups and attract entrepreneurs from the life science sector with its newly founded independent Life Science Factory.

Life Science Factory offers space and support to prospective scientific entrepreneurs and young companies willing to take their first steps beyond the comfort zone of academic institutions. It also provides for the interaction of lab areas, co- working rooms and network offerings, such as mentoring and company financing. The firm’s professional operating concept ensures efficient facility management and administrative support, high-quality laboratory equipment and qualified lab staff.

“In this combination, such an approach is new in Germany and other European countries,” comments Sartorius executive board chairman and chief executive officer, Joachim Kreuzburg. “Life science startups primarily lack suitable lab facilities and a powerful network, apart from access to startup and growth capital. Flexible and open-design spaces for labs, offices and events are a good breeding ground for trying out new things and sharing contacts and experiences with like-minded peers and veteran founders.“

Life Science Factory will work closely with local partners, such as Göttingen’s universities, Max- Planck institutes and the Southern Lower Saxony Innovation Campus, SNIC, and, beyond these, with its wider network.

The non-profit will be ready to start off in early 2019: Office space in the inner city of Göttingen will be available on more than 5,380 sq. ft. (500 square meters) for co-working, experiments and events, and can be rented by entrepreneurs for working and prototype building. The offices will also offer the latest equipment, such as 3-D printers and laser cutters. In addition, lectures to be held by patent attorneys or successful startup founders, for instance, are scheduled as are further events addressing startup issues. Any earnings generated by Life Science Factory will be reinvested in the promotion of knowledge transfer and of young scientists and researchers.

In 2021, Life Science Factory plans to move to the new Sartorius Quarter. Providing a total area of more than 32,280sq. ft. (3,000 square meters), the new facility for Life Science Factory will be one of the first buildings to open in the new city quarter at the previous Sartorius site.

Wasdell Group to Open New Facility

The Wasdell Group announced that it is opening a new facility in Dundalk, Ireland in Spring 19 following a €30m investment.

The 90,000 sq. ft facility will allow Wasdell to offer quality control (QC) import testing for pharmaceutical products, as well as a variety of current and novel packaging technologies. It will also boost its storage and distribution services outside of the UK.

The facility will also futureproof the company’s operations in the event of a hard Brexit when the UK exits the European Union (EU) in March 2019. By giving Wasdell a foothold in Ireland, it will be able to carry out EU release testing ensuring continuous supply for customers regardless of the outcome of Brexit negotiations.

Martin Tedham, chief executive officer at The Wasdell Group said, “With our new facility, we are not only increasing our packaging and analytical testing capacity to better service new and future customers, but with Brexit on the horizon, we are ensuring challenges and costs are minimized by preparing for every eventuality.

The Dundalk facility is the latest phase in Wasell’s investment plan to increase capability and capacity and follows the announcement of its new £500K microbological and analytical laboratory at its Newcastle, UK, site. The company’s ongoing expansion plan will benefit over 120 of the its current customers.

Building work on the site, which is expected to fully operational by spring 2019, began in August 2018. The new facility is expected to create around 800 job ranging from senior management to roles across operations, quality, technical, commercial, financial, warehousing, laboratory and production.

The Wasdell Group is also planning to build an additional facility close to the Dundalk site to expand its distribution offering.

SGD Pharma Upgrades Chinese Plant

The French company has completely redesigned and enlarged the ISO 8 cleanroom.

French pharmaceutical company SGD Pharma has spent €7 million on improving the automation and production capacity of its Zhanjiang plant in China. The site produces 1.2 million Type II & III flint molded glass vials daily for the parenteral market and health care beauty products.

With a surface totaling 914,600 sq. ft. (85,000sqm), the plant features a glass furnace, six production lines, an ISO 8 cleanroom totaling 21,520 sq. ft. (2,000sqm), a resorting room and a customization workshop.

The upgrade project included the rebuilding of the furnace to increase production capacity, improve the quality of glass and offer a better flexibility for deliveries. The investment aimed "to make the Zhanjiang plant an exemplary production center", the company said.

The rebuilt of the furnace took place in February this. This improvement project included the renewal and reorganization of the equipment for the production lines, the cleanroom, the resorting as well as the automation of the decoration workshop.

The energy supply for the furnace has been modified. Previously, it was fuel-based, but now it consumes natural liquid gas, which reduces the carbon footprint. "This transformation brings the furnace into compliance with China's new environmental regulations. In addition to this reduction, the plant has shown a reduction in non-carbon emissions (SO2)," SGD Pharma explained in a statement.

The furnace components have also been transformed to obtain a more precise refinement that improves the quality of the glass. The rebuilt took 40 days and the overall production has increased by 11%, the company said.

At the Hot end zone, for the transformation of glass into flasks, one of the six production lines has been completely renewed. In addition, two lines have been completely upgraded with "the most advanced equipment on the market".

For the Cold end zone, the ISO 8 cleanroom has been completely redesigned and enlarged in accordance with ISO standards. New inspection machines have also been installed for an optimized process.

The plant is certified ISO 15378, 22000 and SA 8000 and benefits from the group's technologies, processes and European expertise for its products made in China.

Apart from the Zhanjiang site, SGD Pharma operates five plants around the world.

PP4CE Partners Build Cleanroom Project in Utrecht

Kuijpers and Brecon have delivered more than 3,766 sq. ft. (350 m2) of cleanroom for the compounding pharmacy at the new Princess Máxima Centre.

The assignment: to design and build a new compounding pharmacy in four months.

Kuijpers and Brecon, members of Professional Partners for Controlled Environment (PP4CE) were chosen to deliver engineering and construction of an advanced pharmacy for the Princess Máxima Centre (PMC). Based in Utrecht, in the Netherlands, PMC opened in June this year to host care and top research for pediatric oncology.

The PMC was built opposite the Wilhelmina Children's Hospital of UMC Utrecht. The initial idea was that the Centre would utilize the pharmacy facilities of the UMC. But, halfway through 2017, it was decided that a separate pharmacy at the PMC would be built.

After a qualitative selection process, PP4CE was awarded the detail engineering. In the contract provision Kuijpers took on the role of coordinating the installations and partner Brecon Cleanroom Systems (BCPS) took on the construction aspect of the cleanroom.

The assignment was clear: to design and build a new compounding pharmacy within the walls of the children’s oncology Centre and make sure that it would be completed by April 2018, or within four months.

The expertise and wide experience of both PP4CE partners resulted in a successful realization of the critical production environments including the compounding pharmacy. To ensure an expedient and successful realization, a collaboration was formed with the client (PMC), the hospital pharmacist, an RTA consultant and builder MedicomZes, a specialist in healthcare projects.

Kuijpers’ task package comprised the construction of all the necessary mechanical engineering installations, including the air treatment, climate, ventilation and lighting. The company was also responsible for the building automation which included the monitoring installations and seamlessly connected the pharmacy installations with those of the hospital.

Brecon took charge of installing more than 3,766 sq. ft. (350sqm) of cleanroom ceiling with HPL finishing. In the Class A and Class B cleanrooms, this system was finished entirely flush.

All walls, doors and windows were part of the modular BCPS (Brecon Cassette Panel System). In the room where the fully automated production takes place, an airtight Metaflex sliding door was installed. All of the construction parts were manufactured at the Brecon production location in Tilburg.

The floors were levelled by Brecon and finished in each room with the Gerflor Mipolam floor system, which includes a hollow plinth finish. The HPL furniture design and pass-through cabinets were also supplied and installed by Brecon Clean Furniture. PP4C partner WERO supplied the final cleaning of the cleanroom prior to validation.

The pharmacy’s cleanroom is comprised of three areas:

An area where non-parenteral (to be injected) medicines are prepared in accordance with the GMP guidelines.

An area where cytostatic parenteral preparations (medicines used for treating cancer) are prepared as well as other parenteral preparations.

Both of these areas have separate air extraction and ventilation systems.

The third area features two so-called RIVA robots delivering fully automation processes, including the preparation of medicines and dispensing labelled syringes, bottles and intravenous drip bags. Because the robots produce a lot of heat, the cooling capacity is found in this part of the cleanroom.

All systems in the cleanroom comply with the GMP guidelines. In the pharmacy, this concerns a series of GMP classifications: ranging from GMP-D in the (general) dressing rooms to GMP-A in the rooms where parenteral medicines are prepared.

Erik Rijpkema, project leader at Kuijpers, commented: “In order to comply with the GMP guidelines, systems must meet the design specifications and be professionally installed down to the smallest detail. This form of control and verification is for Kuijpers and Brecon an ongoing thread when it comes to cleanroom projects, including this one. By constantly monitoring the room conditions, we worked towards an optimal end result.”

The complete modular panel system has been recently tested and certificated by the Fraunhofer Institute for GMP class A and ISO 14644 class 3 cleanroom technology.

SGS Opening New Biopharma Testing Lab in Geneva

The analytical and bioanalytical contract solutions provider SGS is expanding its biopharmaceutical testing capabilities in Geneva, Switzerland.

SGS also provides Phase I-IV clinical trial management, with services including data management and statistics, PK/PD (pharmacokinetic/pharmacodynamic) modeling and simulation, pharmacovigilance, and regulatory consultancy.

The new 2,152 sq. ft. (200 square meter) laboratory, slated to open by the end of Q3 2018, will be equipped with several instruments and complements the company’s existing 8,608 sq. ft. (800 square meter) facility.

Upon completion, the laboratory will offer full ICH Q6B physico-chemical characterization of biological products.

According to SGS, the expansion responds to the “growing need for biopharmaceutical studies during the early and late phase of characterization, as required by the ICH guidelines.”

Services to be offered include circular dichroism (CD), Fourier-transform infrared spectroscopy (FTIR), extrinsic and intrinsic fluorescence, analytical ultracentrifugation (SV-AUC), size exclusion chromatography with multi-angle light scattering (SEC-MALS), dynamic light scattering (DLS), and differential scanning calorimetry (DSC).

“To fulfill regulatory requirements, the biopharmaceutical industry increasingly expects its contract service providers to offer comprehensive characterization capabilities from a single location,” said Luc-Alain Savoy, managing director of SGS Life Sciences Geneva in a press release.

Swedish Government, GE Healthcare Open Innovation Center for Life Sciences

The Swedish government and GE Healthcare are opening Testa Center - an innovation center in Uppsala, Sweden, to boost the commercialization of new technologies and support manufacturing capabilities in the life sciences sector. The 2500 m2 (27,000 sq. ft.) Testa Center houses four bioprocessing laboratories with GE Healthcare technologies for testing new discoveries for the production of biopharmaceuticals, the world’s fastest-growing class of medicines.

The Swedish government, which has invested around EUR 10 million in Testa Center and has identified life sciences as one of its top five partnership programs, is striving to increase collaboration between the public sector, business and academia to strengthen the country’s competitiveness and innovation capability. Earlier this year, the government opened an office that is fully dedicated to life sciences.

“This impressive test bed, Testa Center, which GE Healthcare chose to develop in partnership with the government promotes innovation, strengthens competitiveness and will help us provide more efficient care in the future. This is important for Sweden and our life sciences strategy, as we are facing tougher health challenges globally. People grow older and chronic and lifestyle-related diseases are increasing. Life sciences is a knowledge-intensive sector with a high growth potential,” said Mikael Damberg, Minister for Enterprise and Innovation.

Swedish biotechnology company BioLamina is the first company to run a project at Testa Center. Biolamina develops and manufactures protein-based reagents, Biolaminins used to create reliable and robust processes to develop therapeutic cells from stem cells. The company recently entered into a collaboration with the pharmaceutical company Novo Nordisk to support the development of new cell therapies targeting Parkinson’s disease, heart failure and loss of vision. BioLamina will use Testa Center to scale-up its production capacity, helping it deliver more reagents to its global customer base.

“With the increasing demand of our high-quality laminins within the cell therapy industry, we need to scale-up our production capacity,” said Kristian Tryggvason, CEO of BioLamina. “Testa Center gives us a unique possibility to do this internally instead of relying on large global contract manufacturers.”

In addition to the investment coming from the Swedish government through its innovation agency, Vinnova, GE Healthcare has invested around EUR 4.5 million in the center. The other sponsors are the national life sciences facilitator SWElife, Region Uppsala, the industry organization Uppsala BIO, the Swedish Agency for Economic and Regional Growth and the Foundation for Collaboration between the Universities in Uppsala, Business, and the Public Sector (STUNS).

Testa Center is a national and international testbed open to academia, start-ups and industry. It is purpose-built for verifying digital, technical and biological innovations in an authentic production setting. This helps organizations achieve a more time and cost-effective way to reduce the risks of securing industrial Proof-of-Concept, which is vital for later market introduction and sales. The industrial-standard bioprocessing laboratories up to pilot-scale (non-GMP) are mainly based on single-use technologies from GE Healthcare Life Sciences. The center is owned and operated as a non-profit company by GE Healthcare in Uppsala that also provides operational support and expertise for project owners. The project owners retain full control of their intellectual property and data.

Novartis Is Building a Plant

Novartis will invest about $91 million to build a new production plant at its Stein, Switzerland, site for its CAR-T drug Kymriah, adding to the CDMO capacity it already has for the gene-based drug. (Novartis)

With the approval in Europe of its CAR-T cancer drug Kymriah, Novartis figures demand will call for more production. To crank that capacity up, the drugmaker will build a plant in Switzerland that eventually may employ 450 workers.

The Swiss drugmaker said it will spend CHF90 million ($91.5 million) over three years on an existing building at a production site in Stein, Switzerland, to ensure speedy delivery in the EU of the specialized drug that requires an extensive process to genetically code a patient’s T cells to hunt and kill cancer cells.

In an email, a spokesperson said that Novartis expects to initially have 260 positions and create up to 450 new jobs by 2021.

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"The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options," Liz Barrett, CEO of Novartis Oncology, said in the announcement. "Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before, remaining steadfast in our goal of reimagining cancer."

Novartis announced the expansion plans after the European Commission approved the drug to treat acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL).

Gilead Sciences' Yescarta, a head-to-head rival to Kymriah, also got an EU approval today for DLBCL and primary mediastinal B-cell lymphoma. Gilead recently announced that it's building a CAR-T manufacturing plant at the Amsterdam airport in an effort to cut down on logistics and manufacturing turnaround time. The center will have 300 employees when fully operational, expected in 2020.

Kymriah, a one-time treatment, is priced at $475,000 in the U.S but the Swiss drugmaker didn’t indicate what it will cost in the EU. It said only that it is working with national health and reimbursement authorities on a “fair, value-based pricing approach that is sustainable for national healthcare systems.”

Novartis said it would launch Kymriah initially in the pediatric ALL indication, as it continues to ramp up capacity. Its availability in each country will depend on getting qualified treatment centers up and running.

Besides its plant in Morris Plains, New Jersey, to meet initial demand, the company also has a production agreement with the France-based CDMO CELLforCURE, and an alliance with Fraunhofer Institute which currently makes Kymriah for clinical trials. It said it is working on a technology transfer to a CDMO in Japan.

The process to make the potential cures requires that blood be taken from a patient, cryopreserved, shipped to a manufacturing facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers. Novartis in the U.S. has had a target turnaround time for manufacturing of 22 days.

Last month, the drugmaker said that it had run into some manufacturing issues around its production for relapsed large B-cell lymphoma in New Jersey, explaining that problem revolved around cell variability when treating DLBCL, Barrett explained the label for commercial production is more stringent than in clinical trials for the percentage of viable cells and that production has been out of spec because that percentage has not been met at the more stringent commercial level.

While production was not interrupted, Barrett said Novartis was working closely with the FDA as it figures out how to resolve the issue.

ACG Becomes India’s First In-House Packaging Provider for Oral Solid Meds

ACG has expanded its capabilities by completing its work on a lamination facility to be able to complete all packaging requirements for solid oral medication in-house.

The upgraded operations means that the Associate Capsule Group (ACG) Films & Foil business, based in Pune, India, becomes the first in the country to be able to produce the packaging of oral solid dosage formulation medication in one facility from the raw materials involved – from the resin used to produce films to the raw aluminum used to create the laminate.

CEO of the company, S. R. Shivshankar, answered our question on what the opening of the new facility brings to the company: “The new facility houses a high precision machine with excellent process controls, ensuring the control of specification within the allowed global standards of the final product. By manufacturing the aluminum packaging laminates on this machine, ACG will be ensuring high productivity on the packing line at our customers' end and minimal wastage and appropriate protection of end medicines as per the requirements of the end customers.”

The latter point, in regard to minimal wastage, is one that Shivshankar noted is a growing trend in the industry: “Companies are aligning more and more towards sustainability in the ecosystem – be it a reduction in carbon footprint or more recyclable initiatives or even biodegradability of packaging material.”

Shivshankar highlighted how being able to produce everything in the same facility will allow his company to achieve “identical performance as produced by our competitors in Europe.”

He revealed why this is attractive to potential customers: “We are able to offer comprehensive solutions to customers with all high-performance barrier packaging needs being catered to under one roof. It also helps them mitigate risks in their supply chain and look for newer and more affordable alternatives.”

The Asia-Pacific region is now beginning to accrue a larger share of global pharmaceutical market, through the development of low-cost generics; such growth means that global companies are now looking to make in-roads in the local market and so the evolution of services, such as ACG’s work to match European standards, will be of increasing importance into the future.

Catalent Completes Juniper Merger to ‘Expand And Strengthen’ Oral Dose Manufacturing

Juniper Pharmaceuticals will become a wholly owned subsidiary of Catalent Pharma Solutions, says the CDMO.

Catalent announced the successful completion of its tender offer in a US Securities and Exchange Commission (SEC) filing this morning. The contract development and manufacturing organization (CDMO) paid approximately $130m in cash for Juniper’s stock, priced at $11.50 per share.

As Juniper’s parent company, Catalent will continue to supply Crinone (progesterone gel), marketed by Merck KGaA outside the US.

Earlier this year, the announced plans to invest in its Somerset, NJ, facility, and build a Centre of excellent on America’s East Coast.

In April 2018, Catalent increased its clinical packaging and storage capacity in Philadelphia, PA, with a $5.5m site expansion.

AGC Biologics Expands Capacity at Denmark Facility

Strategic expansion will meet increasing global demand for biopharmaceutical development and manufacturing

As part of its global expansion strategy, AGC Biologics is increasing manufacturing capacity at its Copenhagen, Denmark facility.

The Copenhagen facility will add a single-use bioreactor (SUB) 6Pack suite, consisting of six 2000L production bioreactors and a 2000L seed train. The addition of this proprietary bioreactor configuration will enable more flexible, innovative and customized cGMP production capabilities, offering scales from 2000L to 12000L within a single run. The six bioreactors will be run in single unit operations or in groups; simultaneously, sequentially or staggered; to meet each client's specific production needs.

The expansion also includes additional capabilities for harvesting, purification, buffer and media production that will support the processing of different therapeutic proteins, including high antibody titer processes. The new suites are scheduled to be online in November 2018, and are expected to support the manufacturing of several commercial products.

"We're very pleased to implement this important capital expansion that addresses our clients' evolving needs for increased capacity and customization in development and production," said Gustavo Mahler, president and chief executive officer, AGC Biologics. "The investment in our Copenhagen site enables AGC Biologics to offer more production capabilities within accelerated timelines, while continuing to provide our deep industry expertise, continuous innovation and proven technical excellence."

AstraZeneca Changes Contractors on New HQ

AstraZeneca has pushed back the expected completion date of its new Cambridge, UK headquarters to 2020, after changing contractors.

AstraZeneca (AZ) announced that it has changed the contractor building its headquarters from Skansa to Mace, after a series of delays saw the completion date set back from 2016 to a new provisional date of 2020.

The project was initially announced in 2013, when the company expected the facility to cost £330m ($424m), but has since stated that the cost will be in excess of £500m due to additional features being added.

A statement provided to us by a spokesperson for the company outlined that the facility is now entering the “scientific fit-out and commissioning phase of the project”.

However, the company is yet to give a firm deadline of when employees will begin working from the site, with its own estimate “pointing to the first half of 2020.”

The spokesperson did not confirm exactly why the company has chosen to switch contractors.

More than simply a headquarters, the 11-acre space will host its global corporate offices and an R&D Centre – the latter housing staff from both AZ and its subsidiary, MedImmune.

In total, the site is expected to house approximately 2,000 staff members. The company currently employs over 2,600 staff members in the Cambridge area – one point on the so-called ‘golden triangle’ of the biopharma industry, alongside Oxford and London.

The statement noted that being part of the Cambridge biopharma cluster has allowed the company to establish “significant scientific partnerships and strategic collaborations”.

With Brexit deadlines looming in the near distance, however, the strength of the UK biopharma industry could be tested.

AZ has already revealed that it is planning ahead to mitigate potential fallout from the UK’s exit from the European Union, stockpiling an additional 20% of its medicine to counteract any potential shortage in supply.

ABL Expands GMP Viral Vector Mfg. Capacity

ABL, Inc., a global contract manufacturing organization (CMO) that advances vaccines and therapies from clinical development to the commercial market, has acquired through its wholly-owned subsidiary, ABL Europe SAS, a 69,940 sq. ft. (6,500 square meter) GMP manufacturing site located in Lyon, France.

ABL Europe provides viral vector GMP contract manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch. Maintaining synergy with ABL's contract development and virus manufacturing operations in Strasbourg and Rockville, the new Lyon site will focus on providing ABL's clients with increased options and capacities in response to the rapid growth in demand for the production of viral vectors observed in the immuno-oncolytic and gene therapy space.

"Building on the success since our inception, it becomes a key part of our clients' and ABL's corporate development objectives to expand our virus biomanufacturing service offering," said Patrick Mahieux, general manager, ABL Europe. "Benefitting from the history and presence of a strong biotech community in Lyon, ABL accelerates its growth in viral vector CMO business in the home city of the Institut Mérieux."

Jarlath Keating, president and chief executive officer, ABL, said, "Our recently acquired state-of-the-art biomanufacturing and bioanalytical facility in Lyon will provide additional capacity and flexibility for our global clients, further solidifying ABL's presence in the rapidly growing viral vector and gene therapy manufacturing market. I am delighted to welcome the new team in Lyon as a valuable addition to the expanding ABL family."

Formerly operated under Accinov, the team led by operations director Stephanie Colloud have transitioned to ABL with additional recruitment supporting suite and lab alterations, equipment procurement and qualification; with contract services for process transfer, development and GMP manufacturing of viral vectors to commence in Lyon from end of Q4 2018. The site offers 3 x 200 square meter independent GMP suites with grade B and C classification cleanrooms, plus several self-contained laboratory and office areas providing process development and analytical support.

Chinese Drugmaker Expands Pharma Production Facility

Changzhou Qianhong Bio-pharma starts construction of RMB 1 billion facility for polysaccharides and enzyme drugs.

The groundbreaking ceremony for Changzhou Qianhong Bio-pharma's phase two pharmaceuticals production facility

Changzhou Qianhong Bio-pharma started the second phase of construction at its pharmaceuticals production facility in Changzhou National Hi-Tech District. With an investment of 1 billion yuan (~$150 million), phase two adds 200 million tablets and 60 million injections to production as well as making molecular diagnosis reagents available for use by 20 million people. Changzhou government officials including Liang Yibo and Yan Jun took part in the groundbreaking ceremony.

Changzhou Qianhong Bio-pharma, a leading biochemical maker of polysaccharides and enzymes drugs, is a major manufacturer of pancreatic kininogenase, heparin sodium and low molecular weight heparin, as well as compound digestive enzyme preparations and asparaginase, all of which had, prior to the roll out of the phase one facility, never been produced in China. The entire drug lineup, according to the company, meets international standards in terms of production technologies and quality. Several products have been granted quality certifications by governing bodies in the U.S., the EU and Japan. The company has set up an international marketing network, with products being sold in more than 20 provinces and cities across China as well as exported to markets abroad.

The 1.2 billion-yuan phase one project, which is already in operation, generated sales revenue of 1,070 million yuan in 2017. Phase two, in line with international standards, will focus on the research and development of innovative and first-of-its-class-in-China biological drugs with its own intellectual property rights, with the aim of treating patients with critical illnesses such as cancers as well as cardiovascular and cerebrovascular diseases.

Kaneka Launches Continuous Mfg. Capabilities

Commercial production under cGMP has already been underway as of June 2018.

Kaneka Corporation has installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. Ltd, with commercial production under cGMP already underway as of June 2018.

In the field of small molecule pharmaceutical products, the recent demands have begun to trend toward an increased number of more diversified and smaller volume targets. With these changes, more efficient production technology is needed to address the broad range of targets now required. The installed equipment is a Kaneka designed reactor that allows diversity of application through the ability to select the relevant parameters of the reaction tubing based on laboratory and scale-up research providing the highest performance of reactions.

Kaneka has capability from process development to commercial production with excellent quality assurance, and now aim to expand our solution services in the Health Care business field utilizing this new technology.

Takara Bio Granted Mfg. License from Sweden's Medical Authority

Allows for clinical-grade human embryonic stem cell line derivation and banking.

The Medical Products Agency (MPA), the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drug and other medical products, recently granted Takara Bio a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions at the state-of-the-art laboratory located in Göteborg, Sweden, within Takara Bio Europe's facility.

Since October 2014, Takara Bio has been offering world-class gene and cellular therapy manufacturing and operation as a contract development and manufacturing organization (CDMO) at the Center for Gene and Cell Processing, located in Kusatsu, Japan. The Göteborg facility complements Takara Bio's global efforts to meet the varied needs of clients in the gene and cellular therapy industries.

"I am pleased that Takara Bio Europe's long-standing experience in hES cell derivation is offered as a contract manufacturing service under the MPA license," said Hiroki Tomohisa, chief executive officer, Takara Bio Europe. "We have a proprietary feeder-free hES cell establishment method which is animal- and human-component free. Starting material is retrieved from FDA-compliant sources according to FDA guidelines. This means we are capable of providing a safe, reliable source of hES cells for future cellular therapeutic development for our clients."

GE Healthcare Opens Bioprocessing ‘Test Bed’ for Biotechs

The Testa BioProcess Innovation Center in Sweden will help academics, startups, and biopharmaceutical companies secure industrial proof-of-concepts quicker, and with less cost, says GE Healthcare.

GE Healthcare, which recently announced plans to separate from parent company General Electric, announced the launch of the 26,900 sq. ft. (2,500m²) Testa Center. The Uppsala, Sweden-located site houses four bioprocessing laboratories, fitted out with predominantly single-use, GE Healthcare technologies.

The site is designed to promote innovation in biopharmaceutical technology and manufacturing by offering operational support and expertise for project owners. The site offers industry the opportunity to verify digital, technical and biological projects in an authentic production setting.

The Centre is owned and operated by GE Healthcare as a non-profit company, however, project owners will retain full control of their intellectual property and data.

According to GE Healthcare, which invested SEK 45m (€4.5m) in the Centre, Testa will strengthen the life sciences pool in Sweden.

“Testa Center is a real-life example of a successful public-private partnership that has brought together many key players in Sweden…I believe that many discoveries will be taken to the real world with the help of Testa Center,” said CEO of GE Nordics and Testa Centre, Lotta Ljungqvist.

Testa: An impressive test bed, says Swedish government

The Swedish government has invested approximately SEK 100m in the Centre, which it expects will boost innovation and competition in the industry.

“Life sciences is a knowledge-intensive sector with a high growth potential,” said Sweden’s minister for enterprise and innovation, Mikael Damberg, in an emailed statement.

“This impressive test bed, Testa Center, which GE Healthcare chose to develop in partnership with the government, promotes innovation, strengthens competitiveness, and will help us provide more efficient care in the future,” he added.

The Swedish Association of the Pharmaceutical Industry (LIF) has also voiced its support of the initiative.

”I am very pleased to see that a large international company chose to make this investment in Sweden, together with the Swedish government. The Testa Center is an innovation Centre that can have a positive effect for the pharmaceutical industry as a whole,” said LIF CEO Anders Blanck.

“It is precisely this kind of investment Sweden needs in order for us to become a stronger Life Science nation. I believe this public-private partnership can be very successful,” he added

According to Blanck, the pharmaceutical industry and the Swedish government share a common vision of strengthening the research and development of new drugs, as well as advancing the production of pharmaceuticals in Sweden. “Testa Center is an important step in the right direction,” he said.

According to GE Healthcare, protein-based reagent manufacturer BioLamina has signed on as the first company to run a project at Testa Center, which will see the biotech “scale-up its production capacity, helping it deliver more reagents to its global customer base.”

CEO of BioLamina, Kristian Tryggvason, said the Centre will help the firm increase production capacity: “Testa Center gives us a unique possibility to do this internally, instead of relying on large global contract manufacturers.”

Rapid Novor Expands Proteomics Lab with Third Mass Spectrometer

Rapid Novor has expanded its proteomics lab with the addition of a third mass spectrometer – enabling the company to take on more projects, says CEO.

Rapid Novor’s REmAb antibody protein sequencing platform uses mass spectrometry to distinguish and sequence proteins for monocolonal antibody (mAb) engineering.

The Canada-headquartered company recently tripled its laboratory footprint to create room for the Thermo Fisher Orbitrap Fusion mass spectrometer and the Evosep LC system.

Mingjie Xie, CEO and co-founder of Rapid Novor said the need for expansion was pressing: “Our lab is at capacity, essentially, the machine is really fully booked for all the [outsourced] projects as well as the internal projects we’re taking on for our R&D purposes. So, the extension of this lab will really increase our capacity so we can take on more projects at the same time. So we can get our throughput at a much higher level.”

The company opened the mass spectrometry lab last year and has since launched a commercial service offering, dubbed WILD.

The addition of the new spectrometer supports EThcD fragmentation, which is a “critical” component of Rapid Novor’s WILD method and REmAb platform. According to the company, this fragmentation enables the company to accurately distinguish Isoleucine and Leucine using mass spectrometry.

Xie said, the ability to distinguish the two amino acids through mass spectrometry has previously been very difficult, as they both have the same molecular weight, which mass spectrometry measures as a way of distinguishing proteins. However, with the fragmentation used in WILD they can be distinguished.

While Rapid Novor is not the inventor of this technology, it is the first to commercialize it, according to the company

“For the first time we can use mass spectrometry alone to confidently determine every single amino acid in an antibody protein sequence,” said Xie.

The new addition to the company's facility opened August 17th, 2018.

Sharp Starts Validation Phase of Welsh Clinical Services Centre

The contract packager and clinical supply service began construction of the facility in 2017.

Sharp, a global contract packaging and clinical supply services, has begun the validation phase of Sharp UK, a £9.5 million Clinical Services Centre of Excellence in Rhymney, Wales.

Development of the state-of-the-art, multiple-phase pharmaceutical manufacturing, packaging and distribution facility began in 2017 and is now complete.

The first phase of the expansion has involved renovation of a 109,752 sq. ft. (10,200 m2) GMP facility on the 11 acre site, which will offer clinical trial supplies packaging, labelling, distribution, QP services as well as secure drug storage.

Frank Lis, president of Sharp Clinical Services, said: “Investing in new facilities and increasing our capacity enables Sharp to be even more responsive to customer requirements, while also meeting the growing demand for our services.”

Investment in the facility, which included £500,000 from the Welsh Government, enables the company to satisfy increased demand for global clinical and commercial services. Once complete, it will triple Sharp’s clinical service capacity for the pharmaceutical, biotech and clinical research sectors.

“Sharp UK will allow us to offer a broader range of integrated services from a world-class clinical facility. As such we are developing our manufacturing and analytical capabilities and adding automated bottling, blistering and serialization as well as Interactive Response Technology (IRT) services for clinical trial management.”

“This means we will be able to offer full service support for larger global clinical studies from this new Clinical Services Centre of Excellence.”

The new facility will create 73 new jobs and safeguard a further 70 with support from the Welsh Government.

Indivior Awards BES Design Project

The cleanroom construction company has been chosen to create a new production facility for the opioid addiction treatment specialist.

Boulting Environmental Services (BES) has been awarded a £4 million project to create a new production facility for Indivior at its pharmaceutical campus in Hull, UK.

BES is a specialist in the design and fit out of cleanrooms and specialist pharmaceutical facilities and the new production facility will focus on producing pharmaceuticals for Indivior, a specialist in opioid addiction treatment.

The facility will be ATEX Zone 22/2 rated, requiring all elements of the specification to minimize the safety and operational hazards associated with the high explosion risk environment where hydrogen reactors are an integral part of the manufacturing process

Dale Owen, Design Lead on the project at BES, commented: “This project builds on the experience of designing and constructing ATEX-certified facilities within the BES team, which involves ensuring that every element of the specification is anti-sparking or intrinsically safe. It also involves designing the facility to minimize the impact of any explosion in terms of both health and safety risk and isolation of hazards to localize any unavoidable damage."

Owen continued: “We have carefully considered the commercial, operational and insurance requirements of the project to design a facility that is as safe and efficient as possible, while answering all safety and hazard isolation validation requirements.”

Designed by BES to complement the existing assets at Indivior’s pharma campus in Hull, the new plant forms part of business continuity planning at Indivior, ensuring the company can continue to meet demand while providing the highest standards of health and safety for employees.

BES began the design process for the new plant by reviewing the accommodation currently used for the seven-stage chemical process involved in production.

As part of the business continuity planning strategy, the new building has been designed to allow installation of eight hydrogen reactors, with three of these due for installation at fit out and the addition of the remaining five scheduled for the next two years.

The design has been agreed by Indivior and passed by a DSEAR (Dangerous Substances and Explosive Atmospheres) Consultant, with fit out due to begin by the end of the year.

Adrian Young, Project Manager at Indivior, said: “Our investment in this facility is a vital part of our business continuity planning and we are looking forward to seeing it become operational next year.”

Huber Kältemaschinenbau Opens New Subsidiary in China

Peter Huber Kältemaschinenbau has continued its international expansion by opening a new sales office based in Guangzhou, China. The new subsidiary will serve end users and dealers in the country under the name Huber China.

An opening ceremony of the new corporate building in Guangzhou took place on 1 August 2018. Numerous business partners and customers accepted the invitation and congratulated the newly founded company.

CEO of Huber China Kevin Xie is looking forward to the challenges ahead. He proudly unveiled the logo at the entrance together with CEO of Peter Huber Kältemaschinenbau Daniel Huber.

Located in a modern industrial park in Guangzhou, Huber China’s corporate building features office and training rooms, as well as a product exhibition area and service and storage rooms. Guests were able to visit the premises on the opening day and gain an insight into the 50-year history of the parent company.

Daniel Huber said: “We look forward to serving our Chinese customers even better in the future. For this, Kevin Xie has put together a competent and experienced team for consulting, sales and service.”

In cooperation with long-term business and service partners, the temperature-control technology specialist guarantees nationwide customer service in China. The new premises will also be used as a training Centre to train customers and dealers in the Chinese area even more easily and efficiently

Boehringer Begins Construction at Tablet Manufacture Plant

Boehringer Ingelheim has begun construction of a new production facility for drugs in tablet form, with an expected completion date of 2020.

The new site will be created at a cost of €85m ($99m) that, according to the company’s press release, has been designed for “modern and flexible production”.

The site will be known as the ‘Solid Launch’ facility and is expected to employ 75 people once completed in 2020. It will open in the company’s Germany, Ingelheim, manufacturing base, consolidating the network that the company has built up in Germany – where it is headquartered.

Boehringer emphasized that it is keen to hold a major part of its manufacturing operations in the country, stating that the site represents “an important piece of the puzzle”, in relation to “keeping the entire value-added chain in Germany over the long term, from research through to production”.

As part of this research remit, the company announced that employees working at the completed facility will “develop new production methods for tablets preparations.”

“In Ingelheim, we are thoroughly committed to investing in technologies and processes with high added value. This means that we are not only establishing the centerpiece for global market launches of pharmaceutical innovations here, but also that we will continue to manufacture drugs that require highly complex production technologies,” said Stefan Rinn, Country Manager for Germany at Boehringer, as part of a statement on the announcement.

The company revealed that it had been part of its strategy to relocate its “easier-to-manufacture drugs” to different areas across the globe and concentrate its work in the more ‘complex’ areas within Germany.

For instance, it has looked to strengthen its manufacturing position in China, with expansions to its solid and liquid dose manufacturing plant in Shanghai and the opening of a contract biomanufacturing plant just last year.

Boehringer Ingelheim Biologicals Development Centre (BDC), Biberach, Germany

Boehringer Ingelheim is developing a new biologicals development Centre (BDC) at its Biberach facility in Germany.

Ground-breaking ceremony of the new BDC was conducted in June 2018.

Boehringer Ingelheim is developing a new biologicals development Centre (BDC) within its Biberach plant site in Germany.

The new facility will focus on therapeutic areas such as cancer and immunological diseases.

The foundation stone for Boehringer Ingelheim Biologicals Development Centre was laid in June 2018 and a phased opening is expected to commence in early-2020. Boehringer Ingelheim is making an estimated investment of €230m ($266.4m) in the facility.

The project is expected to create approximately 100 new jobs and increase the size of the development team at Biberach to 500.

The new development Centre will complement Boehringer Ingelheim’s investments in its global biopharmaceutical development network. The company is already investing in a cell culture plant in Vienna, a new production facility for biopharmaceuticals in China, and a production expansion project in California, US.

The new biologicals development Centre at Biberach is part of Boehringer Ingelheim’s long-term plan to expand its biologic drugs development segment, including key therapeutic areas immuno-oncology and immunology.

“The company’s BioXcellence unit operates a pilot plant and two large-scale manufacturing plants for contract manufacturing.”

The share of biologically active substances in the company’s pipeline has been steadily increasing and currently stands at 40%.

The new investment is expected to consolidate the biological analysis, process development and drug manufacturing for clinical trials departments, and minimize the pathways and generating synergies.

The facility is expected to conduct biopharmaceutical drug development in addition to research and development (R&D), increasing the overall development capacity. It is also expected to create capacity for contract manufacturing.

The Biberach plant is one of the biggest biopharmaceutical manufacturing plants in Europe and produces medicinal proteins and antibodies from cell cultures of mammals.

The company’s BioXcellence unit operates a pilot plant and two large-scale manufacturing plants for contract manufacturing at the site. It offers an entire production chain that starts from DNA to fill and finish, alongside customized contract development and manufacturing solutions.

The plant employs fed-batch process as its core technology, but also offers perfusion processes in 2,000l fermenters established as an integral part of the commercial plant. A single-use plant comprising bioreactors from 100l to 500l, as well as a fully-disposable downstream processing facility is also part of the plant.

The facility manufactures clinical and commercial cell banks under good manufacturing practice (GMP), and has generated and released approximately 200 master, working and bioassay cell banks during the last 15 years.

Boehringer Ingelheim:

Founded in 1885, Boehringer Ingelheim has established itself as one of biggest pharmaceutical companies in the world. Headquartered in Ingelheim, Germany, the family-owned company operates globally with 181 subsidiaries and employs approximately 50,000 people.

The company’s operations centers around core business areas, human health, animal health and biopharmaceuticals. It focuses on adding value through innovation and invests more than 20% of its net sales towards the R&D of human pharmaceuticals.

Boehringer also focuses on organic growth from its own resources by forming partnerships and strategic alliances in research. The company recorded net sales of approximately €18.1bn ($21.6bn) in 2017 and spent more than €3bn ($3.59bn) on R&D, which is equivalent to 17% of net sales.

Minakem’s High-Containment Production Facility, Louvain-la-Neuve, Belgium

Minakem is developing a new high-containment production facility at its Louvain-la-Neuve site in Belgium.

The new facility will enable Minakem to safely develop and produce bulk quantities of highly potent compounds economically. It will also extend the company’s capability to manufacture highly potent active pharmaceutical ingredients (API) and antibody drug conjugates (ADC) from small-scale to full-scale good manufacturing practice (GMP) batch releases.

Minakem plans to open the new facility in August 2018 and commence commercial operations in September. The company is expected to employ more than 110 qualified personnel at the new facility.

Minakem is a contract development and manufacturing organization (CDMO) division of chemical production company Minafin.

The new facility is located in Minakem’s Louvain-la-Neuve site in Belgium, which operates as a separate entity named Minakem High Potent.

It is in close proximity to two of Minakem’s existing API sites in Louvain-la-Neuve.

The new high-class production facility will be equipped with a high-pressure preparative chromatography system that permits the isolation and purification of target molecules at different scales ranging from milligrams to hundreds of grams.

Minakem has already commissioned a laboratory covering an area of 130m². The laboratory is engaged in the development of GMP kilo-lab manufacturing, along with appropriate zoning for materials.

“The new Belgian high-containment facility consists of six production lines that are equipped with stainless steel and hastelloy jacketed reactors.”

The laboratory is equipped with state-of-the-art equipment and comprises nine fume hoods and a double-barrier of protection in the form of new generation glove bins dedicated for dry powder handling and high-efficiency particulate air (HEPA) air filters.

Minakem’s HPAPI production is expected to be carried out with an occupational exposure limit (OEL) level lower than 0.1µg/m3.8h. The new facility will also produce antibody-drug conjugate (ADC) toxins at 10ng/m³ levels.

Minakem’s new high-containment facility consists of six production lines that are equipped with stainless steel and hastelloy jacketed reactors varying from 5l to 1,600l in size.

The facility is equipped with different kinds of isolation equipment for batch sizes ranging from 100g to 100kg designed for the safe handling of potent compounds.

The high-pressure chromatography system installed at the facility includes a 50mm column Hipersep® Prep-HPLC system and 300mm column HPLC system capability. It will enable Minakem to manufacture pharmaceutical ingredients that require a high level of purity.

The first phase of the new system is set to commence operations in September 2018.

About Minakem:

Founded in 2004, Minakem is an affiliate of the Minafin Group and headquartered in France. It specializes in the manufacture of fine chemicals, APIs, and production of key intermediates and building blocks for pharmaceutical companies.

Minakem employs more than 450 people at its three facilities located in Dunkirk and Beuvry-la-Forêt in France and Louvain-la-Neuve in Belgium. The company gained ownership of the Louvain-la-Neuve site through the acquisition of Ajinomoto OmniChem, which enabled Minakem to expand its pharmaceutical services and fortify the development of its pharmaceutical market share.

All the facilities of the company are engaged in the production of small, medium and large volumes of complex, regulated intermediates and APIs for the pharmaceutical and life science industries. The facilities are equipped with technologies such as complex multi-step synthesis, halogenation chemistry and steroid chemistry.

Chugai Pharmaceutical’s New Synthetic Research Facility, Tokyo

Chugai Pharmaceutical is developing a new synthetic research facility at its existing location in Kita-ku, Tokyo, Japan.

Announced in June 2018, construction on the new research facility is expected to begin in October 2018 and is scheduled for completion by November 2019. Operations are estimated to commence by January 2020.

Chugai Pharmaceutical is investing CNY4.5bn ($40.5m) in the project, which is expected to enhance the process development for small and middle molecule active pharmaceutical ingredients (API).

Chugai Pharmaceutical’s existing Ukima Research Laboratories in Kita-ku is built on a 337,035 sq. ft. (31,323m²)site and has a total floor area of 636,970 sq. ft. (59,198m²).

The research activities carried out at Ukima Research Laboratories include API manufacturing and product design. The facility also develops quality testing methods and analyses the structure and physical properties of pharmaceuticals.

Chugai Pharmaceutical’s new synthetic research facility will be a six-story building with a total site area of 10,598 sq. ft. (985m²) and floor area of 52,993 sq. ft. (4,925m²).

Advanced containment technologies and research equipment will be installed, which will be leak-proof to protect researchers from being exposed to harmful chemical compounds.

The layout of the new facility will be designed to improve communication among researchers. The facility will be equipped with high-potency API (HPAPI) facilities, which will enable Chugai Pharmaceutical to carry out process development ranging from early development to commercial production of new drug candidates.

The new facility will enable an expansion of existing research activities in regard to high-potency APIs. It will carry out synthetic research, which is expected to further strengthen the process development for small and middle molecule APIs.

The project is aimed to accelerate innovation and productivity through research by speeding up the development processes for new middle molecule pharmaceuticals.

Small molecule drugs penetrate into cells but cannot block protein-protein interactions. They have a molecular weight of 500g per mole (gm/mol), are manufactured through organic synthesis and can be administered either orally or through injection method. Conversely, therapeutic antibodies can act on specific target bodies but cannot pass through cell membranes due to their size.

Middle molecule drugs combine the advantages of both small molecule drugs and therapeutic antibodies. They are able to reach targets that are unapproachable by small molecule drugs and therapeutic antibodies alone, as they have the capability to enter cells and act actively and specifically on targets.

These next-generation medicines have a molecular weight in the range of 500gm/mol and 2,000gm/mol.

Chugai Pharmaceutical:

Based in Tokyo, Chugai Pharmaceutical is a research-based pharmaceutical company that manufactures biotechnological products.

The company specializes in prescription pharmaceuticals and is a member of the Roche Group. It develops innovative products to satisfy unmet medical needs with a specific focus in the field of oncology.

Chugai Pharmaceutical’s research facilities are located in Gotemba and Kamakura in Japan. The company also operates a facility in Singapore, which focuses on generating novel antibody drugs using its proprietary innovative antibody engineering technologies.

Chugai Pharma USA and Chugai Pharma Marketing are two subsidiaries of Chugai Pharmaceutical, which are involved in clinical development activities in the US and Europe.

Facility Profile: West Pharmaceutical Services Lab and Cleanrooms

Size: 220,580 sq. ft. (20,500 sm)

Project team: Arup (design and construction management), Asistec (lab design layout and furniture)

West’s Waterford, Ireland facility is a global center of excellence for West Pharmaceutical Services Inc.'s advanced manufacturing network. The facility, situated on a 44-acre campus, will produce West’s elastomeric laminate sheeting, which is used to package insulin for use in pen injectors. Additionally, it will offer high-value finishing for components, including stoppers and plungers, produced at other West facilities around the world. These services, designed to mitigate the risk of potential contamination and compatibility issues with packaging components, include pharmaceutical washing (Westar RS components), Envision verification, steam sterilization (Westar RU components), and flexible packaging offerings. The facility currently employs approximately 100 people in both local and global functions, with plans for additional hiring. Commercial production in Waterford is expected this year.

The facility was designed to accommodate expansion for multiple product lines in the future and comprises clean manufacturing areas including ISO 5, ISO 7 and ISO 8 cleanroom zones; Water for Injection (WFI) generation; administrative space and an on-site laboratory. The laboratory was designed to streamline West’s different testing workflows for West products, as well as ensure the highest level of safety for our scientists.

The Waterford site will also be among the first in West’s global manufacturing network to produce Westar Select, the latest in West’s Westar quality enhancement offering. In addition to a tighter particulate specification, Westar Select will be made available through an optimized global manufacturing network with multi-site production capabilities to ensure a continuous supply chain, while helping to reduce regulatory complexity for customers.

Completion date: May 2017

Tracelink Serialization Pilot in Ireland

TraceLink, a company specializing in serialization, joined the Irish Medicines Verification Organization (IMVO) pilot program before EU FMD deadline.

Leonie Clarke, IMVO project manager, said, “It’s not a pilot in the classical sense of the word. One thinks of a pilot as a testing system before you release the system live. The system that’s being tested is fully live and fully functioning. So, it’s really a trial run of the whole thing before we go into the stage where it will be mandatory next year.”

Graham Smith, general manager of healthcare and pharmacy at TraceLink related, “TraceLink’s pharmacy application processes different transactions from the pharmacy and displays the response from the National System for the pharmacist.”