PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Selkirk Pharma Plans Manufacturing Facility in West Plains

Selkirk Pharma, a contract manufacturing startup in the pharmaceutical industry, is planning to build a $30 million manufacturing facility on the West Plains.

The company wants to build a 65,000-square-foot manufacturing facility at 9110 W. Granite Ave. in the Pacific Northwest Technology Park, according to an application filed with the city of Spokane, WA.

Selkirk Pharma, which was founded in 2018 by a team of physicians and pharmaceutical leaders, manufactures and packages injectable drug products. The company has an office at 821 W. First Ave. in downtown Spokane.

Selkirk Pharma would use the VarioSys sterile filling system from Bausch and Stroebel to fill and close vials through an automated process using a Skan isolator and Skanfog decontamination technology. The company indicates initial client fills would begin by the end of 2020, according to a company news release.

The West Plains facility would house two additional manufacturing lines. Details are to be announced at a later date, according to the release.

Selkirk Pharma CEO Patrick Haffey declined to provide additional details about the project, including the number of jobs and a construction timeline.

The company is looking to fill positions in engineering, science, manufacturing, information technology and project management, according to its website.

Spokane-based Bernardo|Willis Architects is designing the project.

The manufacturing facility is the latest in a series of developments coming to the West Plains, following Amazon’s announcement to build a 640,000-square-foot fulfillment center, which is scheduled for completion this fall.

Spokane County Commissioner Al French said there’s a number of companies working through plans right now to find the right deal and location for development in the West Plains.

French, who also sits on the West Plains Public Development Authority board, said Selkirk Pharma, Mullen Technologies and Exotic Metals will bring much needed, high-paying jobs to the area.

“That’s the kind of trend we were hoping to be able to foster, and it seems to be materializing from a number of different standpoints, whether it’s advanced or aerospace manufacturing, or cars, or batteries,” he said. “They are good-paying jobs, and we welcome them to the West Plains.”

Orlando Gives Initial OK for Vertical Medical City Tower

Orlando, Fla., approved Ponte Health’s site plan and initial designs for its $1-billion Vertical Medical City project in downtown Orlando, the Orlando Sentinel reported. Ponte’s plans call for a tower rising 444 ft, which would make it the tallest in downtown. The firm, which tweeted that the project’s next step is to submit a foundation design package for city approval, hopes to complete it by 2023.

HPAPI Market Trends: PCI Expands Capabilities

Michael Ellingson of PCI discusses market demand for specialty drug product capabilities and the Rockford, IL expansion.

The growth in targeted therapies for oncology indications is driving demand for highly potent active pharmaceutical ingredients (HPAPIs). For the most part these are small molecule cytotoxic compounds and antibody drug conjugates (ADCs) for cancer indications. Additional therapeutic areas in the HPAPI space include respiratory, hormonal, cardiovascular, and central nervous system disorders, among others.

With more than 20 new oncology therapies launched in the past two years it’s an area that continues to grow for pharmaceutical manufacturers and CMOs. According to MarketWatch, the HPAPI market is expected to exceed more than $28.0 billion by 2024 at a CAGR of 8.5%.

Due to the high level of toxicity, manufacturers must have the appropriate controls, safety equipment, and risk management processes in place to ensure a safe handling and adhere to strict regulatory requirements. Many pharma and biopharma companies opt to outsource to contract manufacturers with the necessary expertise and capabilities to handle highly potent substances.

PCI Pharma Services recently completed an expansion of its Rockford, IL facility to enhance its specialty drug product capabilities. The 30,000 sq.-ft. facility dedicated to specialty drug products now includes four high potent compound capable suites built to ISO8 standards. PCI also built three new secondary packaging areas to deliver increased scalability and installed three new coolers and a new freezer for -20°C to -8°C cold chain requirements.

Contract Pharma spoke with Michael Ellingson, Operations Director, Specialty at PCI Pharma Services about the growth of high potency APIs and the specialized manufacturing capabilities needed to handle them. –KB

Contract Pharma: What special requirements and capabilities are needed for high potent compounds?

Michael Ellingson: The demand for Highly Potent Active Pharmaceutical Ingredients (HPAPI) continues to grow with oncology drugs accounting for nearly 40% of the global clinical pipeline. As we are seeing an increased demand for HPAPI handling, we are focusing on improving our capacity and capabilities to meet customer requirements. To meet these goals, we recently finished the expansion of our existing Rockford, IL facility, which included high potent compound capable suites that are built to IS08 standards. These suites act as a containment measure achieved through negative and positive pressure, and heightened air filtering.

Our teams also work to meet strict regulatory requirements, such as cross-contamination controls, and reliable reproducibility through geometric scale-up. Our facility in Tredegar, South Wales also meets these requirements and we’ve started an expansion at this facility to further support business growth and we expect this new space to be operational in the first half of 2022.

CP: In what therapeutic areas do you see the most growth?

ME: As we continue to see an increase in innovation and research across the oncology ecosystem, there begins to be a stronger need for high potent compounds to support these advancements. Active compounds in oncology research and development has quadrupled since 1996 and doubled since 2008. PCI Pharma Services has supported this growth and has simultaneously seen demands for our services and partnerships increase. We work with our clients from early stage development to long term commercial supply. Staggering growth in oncology R&D presents an opportunity for PCI to increase our manufacturing capabilities and packaging capabilities. We aim to provide services and a supply chain from start to finish – from drug development to commercialization – and as oncology drugs are continuing to be developed, we work with our clients to provide solutions to challenges to ultimately deliver life-changing treatments to patients.

CP: From what pharma/biopharma sector do you see the most demand?

ME: We have seen consistent growth in oncology products, along with high potent compounds and products to treat specific food allergens. The industry has seen a significant shift in the ability of small and mid-size pharmaceutical companies to bring projects to the finish line of commercialization.

Although we continue to see growth in big pharmaceutical companies, the growth rate in small and mid-size companies is outpacing that of their larger peers in the space. As such, PCI has added to our service offerings with clinical support, packaging options and program management skills in the end-to-end commercialization process as to provide start to finish support for customers. For obvious reasons, this support tends to be most critical for smaller, often less experienced, startup customers.

Michael is the Director of Specialty Operations where he focuses on driving process improvements and oversees operational excellence. Prior to his current role, Michael held key positions across PCI’s project management and operations teams. In addition to his responsibilities at PCI, Mike is the site SME for a recent S&OP implementation project where he manages all scheduling, forecasting, capacity analyses and labor management for the Rockford Commercial sites.

Novartis Opens Its Largest Gene Therapy Plant

The doors have opened at a facility in Longmont, Colorado after Novartis acquired it to support its gene therapy business unit AveXis.

In April 2019, Novartis bought the Longmont facility from fellow Big Biopharma player AstraZeneca in efforts to grow out its gene therapy production network.

Nine months on and the Swiss Biopharma has confirmed the site is open and prepped to support its AveXis unit in the production of therapies including Zolgensma (onasemnogene abeparvovec-xioi1), which was approved by the US Food and Drug Administration (FDA) in May 2019.

“The new site will be manufacturing gene therapies for rare genetic diseases, including our FDA-approved gene therapy for the treatment of spinal muscular atrophy (SMA) [Zolgensma],” said Novartis spokesperson Anja von Treskow.

“The facility currently employs more than 300 talented scientists, engineers, analysts and manufacturing and operations personnel.”

While the plant is open, it will not become operational until early next year, she confirmed, but once licensed, it will not only add to sites in Illinois and North Carolina in providing Zolgensma manufacturing capacity but be the largest facility in AveXis’ manufacturing network.

Since acquiring AveXis for $8.7 billion (€7.8 billion) in May 2018, Novartis has invested heavily in its gene therapy production capabilities. Two further investments totaling $115 million have been made, aimed at establishing a gene therapy manufacturing center in Durham, North Carolina and expanding product development at a facility in San Diego, California.

“Colorado is the largest facility square footage wise in the manufacturing network while the site in North Carolina is currently being built out.”

Like the operational Libertyville, Illinois site, the Longmont plant is equipped with iCELLis bioreactor systems, supplied by bioprocess vendor Pall Corporation.

The 700,000 square-foot facility set on 70 acres of land has had a host of Big Pharma owners.

Amgen once used the plant to produce drug substance for its blockbuster biologics Epogen (Epoetin) alfa and Aranesp (darbepoetin alfa).

Then in October 2016, AstraZeneca acquired the plant for an undisclosed fee. At the time the Anglo-Swiss firm said it planned to use the site – together with the nearby LakeCentre facility in Boulder, also bought from Amgen, albeit two years prior – to support its biomanufacturing ambitions.

However, early last year AstraZeneca restructured its operations in efforts to consolidate biomanufacturing at its Frederick, Maryland site and put both Colorado sites on the chopping block.

Argonaut Launches Aseptic Vial Filling Services for Biopharmaceuticals

A California-based CDMO has designed an aseptic filling line to maximize yield of expensive biologics and other high-value drug substances.

Argonaut Manufacturing Services, a biopharma CDMO, has launched its new aseptic vial filling services. The custom Bausch + Ströbel VarioSys filling line has been designed to maximize yield of expensive biologics and other high-value drug substances.

Argonaut worked closely with the Bausch + Ströbel engineering team to design an optimal filling line for biologics.

The new line uses engineering innovation to minimize residual API volumes and optimize weight checks.

Working with equipment manufacturer Bausch + Ströbel, the team designed a fluid path utilizing a single-hose peristaltic pump attached to a single-use needle. This design minimizes both the overall length and internal diameter of tubing, creating less area where API can be retained. Similarly, filters were sized and optimized to minimize dead volumes. This all minimizes residual API volumes.

To minimize API lost to weight checks, Argonaut designed their filling line with in-line, non-destructive 100% weight checks. Every vial is tared before filling and actively measured during the filling process. This allows the vial fill volume to be automatically corrected instead of being discarded.

The company also focused on improving sterility, selecting isolator technology with fully automated robotics in order to combat known contamination sources. In comparison to cleanroom filling and older technologies, closed systems such as restricted access barrier systems (RABS) and isolators reduce contamination risk from the environment and personnel. Combining robotics with isolator technology further reduces human intervention, perhaps the greatest source of contamination risk in aseptic filling.

“As drug substance values continue to rise, we saw a need in the market for fill/finish service providers to adapt. Our line incorporates technologies designed to maximize yield and minimize risk, in order to safeguard every drop of API,” said Chris Duffy, COO of Argonaut.

Key line features include robotics, isolator technology, minimal hold up volume, and in-line non-destructive 100% weight checks.

Eric Blair, CCO of Argonaut, said: “The ADVANCEDFill technology our line features is ideal in the areas of rare disease, orphan drugs, and other small-batch biologics applications. Personalized medicine is driving an industry need for our services, as we have the ability to provide the small batch throughput and near zero-loss yield needed for precious drug substance.”

Argonaut begins serving clinical phase customers in Q1 2020.

Hospital Moves in on Manufacturing Market

Nationwide Children’s Hospital has made competition for pharmaceutical companies by forming an affiliate company that will commercially manufacture gene therapy products. The new Andelyn Biosciences, scheduled to begin operations in 2023, will be central Ohio’s first commercial-scale cGMP clinical manufacturing facility devoted to gene therapies.

Andelyn Biosciences represents an important evolution of Nationwide Children’s Hospital’s current success in clinical manufacturing and gene therapy. The Abigail Wexner Research Institute (AWRI) at Nationwide Children’s is now widely recognized among the nation’s leaders in developing gene therapies, which are becoming safe and effective treatments for previously fatal or untreatable genetic diseases.

For several years, AWRI has operated a small-scale onsite facility focused on the manufacture of early-stage gene therapy products for Phase I and II clinical trials. The current facility operates according to FDA cGMP guidelines for early stage clinical trials to ensure the safety of manufactured biologic products.

Andelyn Biosciences will be established as a for-profit subsidiary company and will continue current GMP operations. Then beginning summer 2020, this facility will manufacture products compliant with phase III clinical trial regulations while the new commercial manufacturing site is built and validated.

“We are on the cutting edge of pediatric gene therapy, and clients from around the world currently access AWRI’s knowledge, resources, experience and technology,” said Dennis Durbin, MD, MSCE, chief scientific officer of AWRI. “The goal of Andelyn Biosciences is to support the advancement of novel gene therapies for rare genetic diseases by building commercial manufacturing capacity which is needed as more of these treatments are developed over the coming years.”

Durbin explained that as a for-profit company, revenues generated by Andelyn Biosciences will allow the organization to reinvest back into the non-profit research mission at AWRI, supporting its commitment to advance best outcomes for children around the world.

To make Andelyn Biosciences possible, Nationwide Children’s is working with key partners including JobsOhio, the City of Columbus, One Columbus and Rev1 Ventures to create jobs and expand central Ohio’s influence in the biotechnology sector.

The Ohio State University’s West Campus innovation district is being explored as a location for Andelyn Biosciences, although an exact location has yet to be finalized.

The name Andelyn Biosciences speaks to the company’s prime mission, representing a hybrid of two pioneering gene therapy recipients who participated in pivotal Phase I clinical trials at AWRI. Andrew Kilbarger was 8 years old when he received the first U.S. human investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn Villarreal was only 8 weeks old when she received investigational gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Packaging Technology Group to Open Kentucky Facility

Packaging Technology Group (PTG), a provider of thermal packaging solutions for the biopharmaceutical and life sciences sector, has opened a new location in Louisville, KY. The new manufacturing facility, slated for completion in April 2020, will allow PTG to add capacity, expand its product portfolio, and create at least 40 new jobs in the Louisville area.

“We are very grateful for Gov. Andy Beshear, Louisville Mayor Greg Fischer and the Kentucky Economic Development Finance Authority (KEDFA) for their support in the great state of Kentucky,” said Bill Blezard, chief executive officer, PTG. “This new location reinforces our continued commitment to our clients and partners in the biopharmaceutical and life sciences industry.”

PTG recently launched its product line of thermo-efficient, 100% curbside recyclable, and environmentally sustainable solutions, TRUEtemp Naturals Cellulose. The TRUEtemp Naturals Cellulose Shippers are designed with a unique, curbside recyclable insulating fiber composed of layers that protect against impact and temperature fluctuation.

“Pharma cold-chain logistics is predicted to grow to $18 billion by 2022 as the demand for temperature-sensitive health care products continue. We have made significant investments in our infrastructure, team, production, and lab equipment, and this expansion was a natural next step,” said Thomas Lawlor, chief operating officer, PTG. “This provides us redundant manufacturing capabilities while substantially increasing our capacity for our cellulose line of products.”

BridgeBio Pharma, Catalent Enter Gene Therapy Alliance

BridgeBio Pharma and Catalent have entered a collaboration agreement to establish dedicated gene therapy development and manufacturing capacity at Catalent’s Paragon Gene Therapy clinical and commercial manufacturing center in Harmans, MD. The agreement is intended to support the clinical and commercial manufacturing needs for BridgeBio’s gene therapy product candidates for congenital adrenal hyperplasia, BBP-631, and Canavan disease, BBP-812.

Catalent’s commercial facility is fully compliant with cGMP requirements and allows for up to 5000 liters of production. The over 400,000 square feet footprint is complete with all necessary support functions for storage and fill finish for final product supply.

“Having flexibility and greater certainty in manufacturing capacity is critical to success in gene therapy,” said Eric David, chief executive officer of BridgeBio’s gene therapy subsidiaries. “Catalent’s Paragon Gene Therapy arm has been our trusted partner for almost two years, and this expansion of our relationship is intended to allow for smoother clinical and commercial development, as well as an acceleration of our pipeline programs, helping us move faster to address critical unmet health needs for patients and their families.”

“Catalent’s expertise in the cGMP manufacturing of viral vectors complements our internal investment in the CMC process and analytical development to support our gene therapy portfolio,” said Fred Porter, senior vice president of CMC and technical development of BridgeBio’s gene therapy subsidiaries. “Securing dedicated capacity for the delivery of clinical and commercial supply is critical to our long-term strategy.”

Pete Buzy, president of Paragon Gene Therapy, said, “It is Catalent’s continued goal to grow with our customers and to be able to offer them secure, state-of-the-art gene therapy facilities for their critical clinical and commercial needs. For gene therapies, the manufacturing scale-up process is complex and unique. Therefore, for our partners, having access to advanced adeno-associated virus production expertise and experience is vital to progress these pioneering treatments towards commercialization and the patients who need them.”

Amgen R&D Facility in South San Francisco Biotechnology Hub

Amgen announced the signing of a lease with BioMed Realty for a new 240,000-square-foot Leadership in Energy and Environmental Design (LEED) candidate facility in the Gateway of Pacific campus development in South San Francisco. The new location, currently under construction at Oyster Point, will house Amgen's Bay Area employees focused on cardiometabolic, inflammation and oncology, research.

"At Amgen South San Francisco, we are home to top scientific talent, integrating human genetics with core biology and molecular engineering to discover and develop first-in-class therapies," said Amgen's South San Francisco site-head Flavius Martin, vice president, Research, Oncology and Inflammation. "The new location will foster even greater collaboration across our strong scientific team, accelerate the R&D process, and provide a venue for increased engagement with the Bay Area's abundant scientific and educational communities."

Amgen has been part of the vibrant South San Francisco biotech community for 15 years. The company's new home at The Gateway of Pacific campus will be a facility that boosts collaboration via modern work and laboratory spaces. The new site will include modular green wet labs and green molecular lab design. It will provide a flexible and a customizable state-of-the-art scientific research and development facility to support scientific research.

In addition to enhanced R&D laboratory and office space at the new nine-story facility, which is scheduled to open in early 2022, the new campus will house a variety of meeting spaces, an amenity center that includes a number of dining options, a health club and a variety of outdoor recreation areas.

About Amgen:

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

GE Healthcare Life Sciences and UMass Medical School Establish Large Scale Viral Vector Manufacturing Facility

The new facility will help alleviate bottlenecks in manufacturing that impact preclinical research.

GE Healthcare (GEHC) Life Sciences and the University of Massachusetts Medical School (UMMS) have come together to establish a Large Scale Viral Vector Manufacturing Facility. The new facility will provide large quantities of high-quality recombinant adeno-associated virus (AAV) vectors for preclinical research. The facility will be housed on the University of Massachusetts Medical School’s Worcester campus.

Preclinical research capabilities are limited due to a lack of large- scale viral vector manufacturing facilities. Researchers often have to wait 12 to 24 months to secure enough vector for their research. This large scale AAV manufacturing facility will alleviate the bottlenecks that delay the start of preclinical research. Additionally, researchers will have access to GE Healthcare’s processing equipment and the assistance of professional staff at the facility helping to get their research to the clinic faster.

Catarina Flyborg, General Manager of Cell and Gene Therapy, GE Healthcare Life Sciences, says: “Accelerating research that brings novel cell and gene therapies to patients is the mission of our business. By partnering with UMass Medical School to create this large scale AAV manufacturing facility, we will provide researchers with the tools and AAV needed for pre-clinical research that will advance the cell and gene therapy industry and get therapies to patients faster.”

“The potential of gene therapy to treat human disease has finally become a reality” says Terence R. Flotte, MD, professor of pediatrics and dean of the School of Medicine at UMMS. “However, the ability to move the field forward to treat additional serious diseases remains limited by the efficiency and flexibility of producing gene therapy vectors suitable for testing in new disease models. Our partnership with GE Healthcare addresses this critical challenge. The strength of this academic-industry collaboration between two of the commonwealth’s leaders in this field gives us a great deal of optimism that we will overcome this challenge.”

The facility will be 3,220 square feet and will feature a good laboratory practice (GLP) viral vector FlexFactoryTM. Four to six professional staff will manage the day-to-day operation and the facility will be fully operational in 2020.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School (UMMS), one of five campuses of the University system, is comprised of the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing, a thriving research enterprise and an innovative public service initiative, Commonwealth Medicine. Its mission is to advance the health of the people of the commonwealth through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. In doing so, it has built a reputation as a world-class research institution and as a leader in primary care education. The Medical School attracts more than $264 million annually in research funding, placing it among the top 50 medical schools in the nation. The 2013 opening of the Albert Sherman Center, home to the research lab of 2006 Nobel Laureate Craig C. Mello, PhD, ushered in a new era of biomedical research and education on campus. Designed to maximize collaboration across fields, the Sherman Center is home to scientists pursuing novel research in emerging scientific fields with the goal of translating new discoveries into innovative therapies for human diseases. For more information, visit www.umassmed.edu

About GE Healthcare Life Sciences

GE Healthcare Life Sciences helps therapy innovators, researchers and healthcare providers accelerate how precision diagnostics and therapies are invented, made and used. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE (NYSE: GE). With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, GE Healthcare helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world.

HHS Invests in U.S. Manufacturing Capacity for Pandemic Influenza Vaccine

The U.S. Department of Health and Human Services (HHS) issued a six-year, $226 million contract to increase capacity to produce recombinant influenza vaccine in the United States. The contract is in accordance with the Sept. 19 presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.

The work will take place through a public-private partnership between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and Sanofi Pasteur, a global pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey.

“Influenza viruses can spread rapidly around the globe, infecting hundreds of millions of people in just weeks, making technologies that quickly and safely produce effective influenza vaccines fundamental in responding to an influenza outbreak,” said BARDA Director Rick Bright, Ph.D. “Keeping vaccine manufacturing in the United States is essential to protect Americans from pandemic influenza and to save lives. Better, faster vaccine technologies, produced in the U.S. will improve access, protect more people and, ultimately, strengthen our nation’s health security.”

Recombinant vaccine technology can produce new vaccines faster than traditional egg-based technology. Currently, Sanofi Pasteur is the only company with a seasonal recombinant influenza vaccine licensed in the United States and with the resources to leverage this technology for pandemic influenza preparedness.

To expand and retain domestic recombinant influenza vaccine capacity, Sanofi Pasteur will retrofit vaccine manufacturing facilities in Swiftwater, Pennsylvania. When the project is completed, it will double Sanofi’s recombinant protein-based influenza vaccine manufacturing capacity in the United States. The agreement with Sanofi Pasteur includes options for an additional facility at this site to be retrofitted to produce adjuvant; development and licensure of an adjuvanted, recombinant pandemic influenza vaccine; and HHS access to the vaccine production capacity for up to 25 years after the manufacturing facilities are completed. As a result of this agreement, Sanofi Pasteur could provide nearly 100 million doses of recombinant influenza vaccine for use during a pandemic.

An adjuvant is an ingredient used in some vaccines to help create a stronger immune response in people receiving the vaccine, meaning that adjuvant helps vaccines work better. Vaccines containing adjuvants are tested for safety and effectiveness in clinical trials before they are licensed for use in the United States, and when approved, they are continuously monitored by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Since 2007, 52 BARDA-supported products have achieved regulatory approval, licensure or clearance. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.

Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.

Colorcon Completes Manufacturing Expansion

Colorcon, a global excipient company, has completed a major expansion and renovation at its North America production facility in West Point, Pennsylvania.

The multimillion-dollar investment enhances the supply chain robustness for products manufactured and delivered to the makers of solid oral dosage products throughout the US, Canada, Puerto Rico, Mexico, Colombia, Peru, Bolivia and the northern areas of Central and Latin America.

Martti Hedman, Colorcon CEO, said: “Colorcon’s West Point site is one of seven film coating manufacturing sites strategically located around the world and is an important component in Colorcon’s Business Continuity Plan. This multi-year investment helps Colorcon to further improve its service to the customers and is a good example of how Colorcon invests in new capacity ahead of demand”.

Colorcon’s investment sees the consolidation of multiple legacy buildings into one unified, best-in-class manufacturing campus. The merging of these facilities provides customers with traceability on raw materials and finished goods and will meet and exceed the regulatory requirements of the FDA and other global regulatory and certification bodies.

There are also environmental benefits through the reduced transportation of materials between sites, reducing traffic in the area. And, with the upgrading of all air handling systems, there will be less environmental noise and more efficient use of the natural resources and utilities necessary to our production process.

Simon Tasker, President of the Americas region explained: “The investment in our West Point facility brings together expanded material warehousing and new best-in-class quality control laboratories to the existing production capabilities. This supports our future growth expectations, improves our environmental footprint and reduces supply lead times for our customers.”

Parsolex’s CGMP Manufacturing Facility Expansion

In November 2019, Parsolex, a contract development and manufacturing organization in the US, partnered with Bosch Packaging Technology to equip its West Lafayette facility with the latest pharmaceutical packaging technologies.

The strategic co-operation will allow Parsolex to provide its clients with access to the latest solid dosage technology innovations in granulation, coating, tablet compression and capsule weight sorting.

The current Good Manufacturing Practices (CGMP) manufacturing facility is equipped with Bosch’s state-of-the-art granulation, fluid bed coating and drying, tablet compression, tablet drum coating and capsule weight checking technologies.

Parsolex CGMP manufacturing facility is in the Purdue Research Park in West Lafayette, Indiana, US and registered with the US Food and Drug Administration (FDA).

The equipment and systems installed at the Parsolex GMP center include the Pilotmix high-shear mixer and Pilotlab fluid bed device. The platforms deliver granulation and accurate coating capabilities, including high-shear and spray granulation, as well as fine particle, pellet and micro tablet coating and drying.

The facility also has pneumatic material transfer capabilities for closed transfers of product to enhance production efficiency. The advanced comminuting platforms at the facility further ensure preferred particle size distributions by milling and sifting of dry and wet powders.

The plant also includes a TPR-200 tablet press, which increases Parsolex’s tablet compression production rate by two-fold, while offering flexibility, better yields and rapid changeover times.

The facility is also equipped with the Solidlab-2 drum coater, which offers eight functions in a single device to easily scale-up production parameters for drying, granulation and coating or layering.

The KKE-1700 capsule weight checker at the facility offers 100% gravimetric capsule weighing. It further improves the existing capsule filling capacity of the plant.

The capabilities will support cGMP production for clinical trial materials (CTM) and commercial drug products for its clients.

“The location has air, bus, rail and trucking accessibility and is well-connected to major cities including Indianapolis, Chicago, St Louis and Cincinnati.”

Parsolex will also employ Bosch’s modular data acquisition systems at the operational units of its facility. The data acquisition systems will report the design and development of optimal process parameters to improve statistical control over processes.

Parsolex also monitors Bosch’s compliance with good automated manufacturing practice (GAMP 5) guidelines during software design, which is essential for the company to comply with 21 CFR Part 11 regulations.

The partnership will enable Parsolex to continue its scientific and operational excellence while addressing more complex formulation and drug product manufacturing challenges faced by its clients.

Parsolex and Bosch Packaging Technology will also undertake joint research projects, which will validate the cutting-edge packaging technology of Bosch Packaging.

Marketing commentary on Parsolex:

Parsolex GMP Center (formerly Purdue GMP Center), doing business as Parsolex, is headquartered in West Lafayette, Indiana. It is a leading contract development and manufacturing organization (CDMO) offering analytical, development and manufacturing solutions to clients dealing with non-sterile pharmaceutical products.

Founded in 2004, Parsolex is equipped with state-of-the-art manufacturing and analytical technologies, formulation design, process development, scale-up, manufacture and packaging for a range of oral solid dosage forms including tablets, film-coated tablets and hard gelatin capsules filled with powder, granule and coated-beads.

The company also operates an analytical testing laboratory to support long-term International Council for Harmonisation (ICH) stability studies and CGMP warehousing. The client base of Parsolex includes leading academic institutions, major hospitals and pharmaceutical companies of all sizes and stages ranging from entrepreneurial ventures and start-ups to established global firms.

Alcami to Expand Charleston Operations

Alcami Corp., a provider of custom services for the pharma and biopharma industries, plans to expand its current operations in Charleston County, SC. The $17 million investment will add approximately 6,000 sq.-ft. to the facility, substantially augmenting capacity for sterile drug product development and manufacturing operations. The expansion is expected to create 30 new jobs. The expansion is expected to be completed in 2021.

Alcami provides a variety of services for small and midsized pharma and biopharma companies from the North Charleston site.

“The build-out of our Charleston facility comes at a time of rapid growth for Alcami and represents a long-term commitment to our sterile drug product clients, our talented workforce, and the greater Charleston area. Our clients expect the most advanced manufacturing technologies and capabilities, and this expansion will ensure we continue to exceed marketplace expectations by remaining on the forefront of industry needs,” said Alcami site director, Darold Hill.

Operating in North Charleston since 2001, Alcami offers a variety of solutions tailored to small and midsized pharmaceutical and biotechnology companies.

PharmaLink Announces Facility Expansion

PharmaLink announced that it started Phase 1 of its expansion project in response to new contracts and increased demand for its reverse distribution services.

The first phase of PharmaLink's expansion project will increase its capacity to 76,000 square feet at its current facility. The company presently leases 51,000 square feet of industrial warehouse space at the Bardmoor Palms Business Park in Largo, Florida, formerly the corporate headquarters of Eckerd Drug. Driven by strong and consistent growth, this investment initiative increases production capacity by 50% and accommodates the company's expanding operations team, which has more than doubled over the past two years.

"The investments we are making in our operations are a strong reflection of PharmaLink's position in the marketplace and positive outlook for the future," said Thierry Beckers, its President & COO. "I'm excited that our team and state-of-the-art facilities are well-positioned to respond to the changing landscape of the healthcare supply chain and the increasing demand for our services and innovative technology."

Once the first phase expansion is complete in March 2020, the company will initiate Phase II, which will include automation, innovative services, and modern facility design, all of which will provide a new paradigm in reverse distribution.

FDA Opens Educational Center

In an aim to improve quality assurance and control of compounded medicine, the US FDA opens a Compounding Quality Center of Excellence.

This initiative by the US Food and Drug Administration (FDA) looks to provide ‘accessible learning tools’ which will support reliable production of compounded products that meet the regulator’s standards, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, explained in a statement.

Moreover, Woodcock stated that the FDA plans to boost its engagement with outsourcing facilities through the operations of the Center.

The agency stated that compounded drugs present a greater risk for patients compared to FDA-approved products, since they are not required to undergo the premarket review for safety, effectiveness and quality.

Establishment of the Center of Excellence follows inspections of outsourcing facilities where production conditions concerned the agency, resulting in recalls of compounded drug products and enforcement action. The need to address this issue was highlighted earlier this year, when Woodcock announced plans for the agency to center the drug compounding regulatory operations in the Office of Compliance.

According to the announcement, the Center will have these main areas of focus:

In-person and online education and training

A conference to give outsourcing facilities, stakeholders, and the agency an opportunity to exchange ideas and best practices

Market research to help inform the agency on key issues faced by outsourcing facilities

Training programs

In-person training will begin in March of this year, with more courses scheduled throughout 2020. Training topics include sterile compounding, environmental monitoring, investigating quality issues, initiating corrective and preventive actions, and proper cleanroom design and practices.

Participants at the training programs would be registered outsourcing facilities and pharmacies that are considering becoming outsourcing facilities. Registrations for the March courses are already open.

The FDA pointed out that the focus of these programs will be put on key aspects of current good manufacturing practice (cGMP) and FDA policies, aiming to enhance the participants’ understanding of necessary procedures and guidelines.

Online education programs will also run, focusing on cGMP, as well as other facets of drug compounding, and they will be offered for free.

Finally, as part of the Center of Excellence initiative, the FDA will conduct market research in order to “better understand the possible barriers and opportunities outsourcing facilities may encounter.”

This refers to issues such as business growth and viability, adhering to cGMP regulations and interactions with the FDA.

REST OF WORLD

Nanoform files for GMP Certification

Nanoparticle medicine enabling company, Nanoform, has filed for GMP status with the Finnish Medicines Agency, FIMEA. The drug substance application for GMP clinical manufacture certification exemplifies its progress and growth in the last 12 months.

Nanoform has implemented a new Quality Management System in preparation for the submission, having appointed talented individuals with significant experience in Quality management and GMP manufacturing.

The certification will enable a seamless transition from non-GMP feasibility studies into GMP clinical manufacture, enabling clients to deliver Nanoformed APIs to human patients in clinical trials. Achieving GMP status will further expedite international commercialization of Nanoform’s nanonization technology, which has the ability to double the number of drug compounds that reach clinical trials through improved dissolution rates and bioavailability enhancement. Building on the significant dose reduction capabilities recently evidenced by Nanoform in pK studies, the company is now well positioned to translate this value for patients globally.

As winners of the Excellence in Pharma Award for Formulation at the 2019 CPhI Awards, the application rounds off a successful year for Nanoform. The company aims to continue its rapid rate of progress in 2020 once the GMP license is awarded for clinical and commercial manufacture.

David Rowe, Nanoform’s Head of Manufacturing, said: “Filing for GMP status with FIMEA is a key milestone in Nanoform’s history. We look forward to working with our partners to deliver enhanced APIs to clinical trials and to help provide patients with faster access to innovative new treatments.”

Niklas Sandler, Nanoform’s Chief Technology Officer and Accountable Director, said: “We are delighted to end this exceptional year with our application for GMP clinical manufacture certification. By expanding our manufacturing capability, we are on course to increase the number of partners who benefit from our best-in-class nanoparticle engineering technology.”

Factory-in-a-Box Startup Hopes to Be Microsoft of Cell Therapy

A start-up based in Cambridge, U.K., is hoping to become the Microsoft of cell therapy, thanks to an innovative approach to 3D printing. BiologIC Technologies, founded earlier in 2019, hopes to democratize the manufacture of therapies like CAR-T with a factory-in-a-box able to run multiple cell therapy workflows and small enough to sit on a laboratory bench.

“We’re hoping to develop an ecosystem—a standardized platform on every bench and in every lab,” explained BiologICs co-founder Nick Rollings. “If you look at the computing revolution, the PC enabled that, but there’s nothing like that in life sciences.”

The company, which is currently self-funded, already has a virtual prototype of their factory-in-a-box. They also showed GEN a prototype of one of the cartridges that will fit inside the box.

The cartridges, said Rollings, combine milli-fluidic and micro-fluidic “circuits” that can run multiple cell therapy “programs.” Unlike typical lab-on-a-chip devices, they don’t intend to use mass production techniques to create the cartridges, but rather novel 3D printing techniques.

“Our differentiator is using 3D printing to fabricate systems in a brand-new way,” noted Rollings. “To give a parallel, life science automation today is analogous to the electronics industry in 1958 when systems were made up of multiple separate components such as valves and transistors. Bob Noyce created the first integrated circuit by integrating and miniaturizing these in a new way.”

He described their platform as being similar to a PC, but—rather than running software like Excel or Word—it will run customized “physical firmware.” This differs, Rollings claimed, from existing companies who are using 3D printing to improve the production of existing equipment, such as chromatography columns.

“To our knowledge, we don’t think there’s anyone else thinking about this, in this way,” said Rollings, an engineer by background. He hopes their technology can help democratize and decentralize the production of cell therapies, such as CAR-T, allowing them to reach a wider range of patients.

The fledgling company is currently talking to angel investors and venture capitalists around Cambridge. They hope to launch a first round of seed funding in the first half of next year.

Catalent Completes Purchase of Biologics Fill-Finish and Oral Solid Dose Facility

Catalent announced the completion of the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy.

The 28,000 square-meter (305,000 square-feet) facility offers capabilities in aseptic liquid and powder filling for biologics and sterile products across multiple vial sizes, and comprehensive primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. Catalent has also announced that it plans to make further investments in the site’s growth.

“The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply,” said Alessandro Maselli, Catalent’s President and Chief Operating Officer. “Anagni provides our European customers with great biologics and oral dose capabilities that can help us reduce time-to-market, simplify tech transfers, and minimize program risk.”

As part of the acquisition, Catalent will continue to manufacture the existing Bristol-Myers Squibb product portfolio currently produced at the site.

UCB Commits to Biologics Manufacturing Plant

UCB outlines plans to invest €300m in Belgian biologics plant, creating 150 jobs.

Construction of the facility in Braine l’Alleud, Belgium is due to start soon. If all goes to plan, UCB will bring the plant online in 2024, providing it with commercial-scale biologics capacity to support its pipeline and portfolio of monoclonal antibodies.

The investment reflects the changing composition of UCB’s pipeline and portfolio. Today, UCB lists 10 biologics and two small molecules in its clinical-phase pipeline. Early in 2018, UCB’s pipeline featured nine biologics and four small molecules. Further back, UCB’s pipeline was dominated by small molecules.

Kirsten Lund-Jurgensen, EVP and head of supply and technology at UCB, framed the investment as a consequence of the changes to the pipeline.

Lund-Jurgensen said, “The shift of our pipeline towards large molecules requires us to ramp up investment in mammalian technical development, as well as our manufacturing capabilities. And the presence of our Biotech Sciences Team, Bio-Pilot plant and diverse research capabilities on the same site will ensure accelerated product launches and supply reliability.”

UCB’s Braine l’Alleud site, which employs around 1,800 people, has experienced some tough times as the company has gradually transitioned from small molecules to biologics. In 2008 and 2009, UCB laid off around 500 people at the site as part of an effort to remove drugs that offered low returns from its portfolio.

The seeds for the revitalization of Braine l’Alleud were planted around the same time when UCB put €65m ($72m) into a pilot plant designed to manufacture biologics for use in clinical trials – the same pilot plant has supported UCB’s growing pipeline and portfolio of biologics.

In the first half of 2019, biologics accounted for around 38% of UCB’s revenues, a slight increase over the previous year. The trend reflects double-digit growth of Cimzia (certolizumab pegol), a biologic treatment for chronic inflammatory conditions, and similarly steep declines in sales of established small molecules.

The composition of UCB’s clinical-phase pipeline suggests the proportion of its sales derived from biologics will increase in the coming years.

Evenity (romosozumab), a biologic treatment for metabolic bone diseases, won approval in Europe last month. A clutch of biologics against diseases including myasthenia gravis, psoriasis and systemic lupus erythematosus are following Evenity down the pipeline, leading UCB to conclude it will need extra capacity in the future.

Tessa and CellVec Both Set Up Singapore Plants

Tessa Therapeutics will open a plant in Singapore for its CAR-T programs, while CellVec has opened a viral vector facility on the island state to support customers’ gene therapy projects.

Singapore-based biotech Tessa is developing its own autologous cellular therapies and has told us it plans to open a 90,000 square-foot plant to support clinical and commercial efforts.

“Tessa will use the new facility for the clinical and future commercial manufacturing of our late-stage clinical programs,” the firm said, adding the plant will “enable Tessa to advance our CMC (Chemistry, Manufacturing and Controls) development efforts, from early phase clinical development through to commercialization, and for potential BLA submissions.”

Tessa’s programs include a Phase II pivotal clinical trial for a Chimeric Antigen Receptor T-cell (CAR-T) therapy targeting relapsed or refractory classical Hodgkin Lymphoma and a Phase III clinical trial for a Virus-Specific T-cell (VST) therapy targeting nasopharyngeal cancer.

The facility, set to open later this year, is expected to be able to supply about 3,000 patients annually and will allow Tessa to have control over its own processes and supply chain.

“Building up in-house capabilities will enable Tessa to retain our cell therapy manufacturing know-how and gain better control over the complex operations and processes involved in manufacturing and vein-to-vein supply chain logistics of personalized cell therapies,” the firm told Bioprocess Insider.

“An in-house facility will also add agility to our manufacturing approach, enhance our manufacturing response time in accordance to our clinical development strategy and optimize speed-to-market when we enter into the commercialization phase.”

Tessa is not currently using a contract development and manufacturing organization (CDMO).

The South-East Asian outpost has been a hub for biomanufacturing for decades, and continues to attract investment. GSK and Amgen have recently opened next-generation facilities on the island state, while CDMOs including Lonza and WuXi Biologics have invested in Singapore.

“Singapore has a ready pool of biopharmaceutical talent that we can tap on for our manufacturing operations once the new facility is operational,” Tessa said.

“The country is also an emerging regional hub for biomedical innovation and commercialization with world-class logistics, and IP protection expertise – all of which are important factors that will help us achieve a market leadership position in the cell therapy space.”

Backing this up, gene therapy CDMO CellVec has just opened a GMP facility dedicated to viral vector manufacturing in the region.

According to co-founder and CSO Lucas Chan on Linkedin, CellVec’s “manufacturing process for lentiviral vectors support up to pivotal phase clinical development and is compliant to EU / US FDA GMP requirements.” He added the firm is “open to enquiries regarding manufacturing slots.”

PPD Sets Out Plans as It Launches New China Labs

The Renaissance Capital see private-cum-public-cum-private-cum-public CRO PPD putting down a very conservative $100 million IPO attempt, but it could raise a cool $1 billion.

The pharma services major filed with the Securities and Exchange Commission to raise up to $100 million in an IPO, but Renaissance Capital says: “However, the deal size is likely a placeholder for an IPO that we estimate could raise $1 billion.”

The CRO went private all the way back in 2011 when it was bought by Carlyle Group and Hellman & Friedman in a $3.9 billion deal. Two years ago, it recapitalized, with the owners expanding the company’s ownership to include two new investors: a subsidiary of the Abu Dhabi Investment Authority and an affiliate of GIC, Singapore’s sovereign wealth fund.

This valued the company at around $9 billion; it currently makes about $4 billion in revenue a year, with clinical development services making up more than 80% of that revenue and the rest coming from its lab services unit.

It plans to list on the Nasdaq under the "PPD" ticker.

As well as an attempted IPO, PPD says it is also boosting its operations and leadership team in China to “provide enhanced clinical development, laboratory, regulatory, site conduct, patient access and post-approval services for international and China-based biopharmaceutical companies.”

It hopes to delve deeper into the often tumultuous but potentially major China market; PPD already has a presence there with clinical development offices in Beijing and Shanghai but will now double down on these, while also opening new offices in Guangzhou and Shenyang.

Going forward, the company said in a statement: “In 2020, PPD Laboratories plans to open a multifunctional lab in China offering bioanalytical, biomarker and vaccine sciences services. In addition, the company’s Accelerated Enrollment Solutions (AES) business—which offers distinctive site conduct and patient access solutions—added China to its global footprint for delivery of performance-based enrollment solutions for chronic ambulatory trials, leveraging its partnership with more than 300 hospitals in China.”

To oversee this growing business in China, PPD has also now named Ding Ming, Ph.D., as vice president and general manager of the company’s China operations, while Di Cindy Wu has been named executive director of PPD Laboratories to "provide direct oversight" of the company’s lab ops in China and Singapore.

“The new laboratory we plan to open in China this year will significantly enhance our capabilities in the Asia-Pacific region, where we already have central labs in Shanghai and Singapore,” said Christopher Fikry, M.D., executive vice president of PPD Laboratories.

“Because it will include bioanalytical, biomarker and vaccine laboratory capabilities combined in one location, this new facility will enable us to better support the global needs of our customers and further establish PPD as a leading drug-development laboratory in China.”

Thermo Fisher Scientific to Expand Global Bioproduction Capabilities

Thermo Fisher Scientific announced it will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media, according to a Nov. 5, 2019 company press release.

"More and more customers are outsourcing their liquid manufacturing to ensure the highest quality while delivering efficiency," said Cory Stevenson, president of Thermo Fisher's bioproduction business. "This investment will expand capabilities and expertise at our existing cell-culture manufacturing center of excellence in the UK to meet growing customer demand for our industry-leading bioproduction products."

The expansion is set to be complete by June 2021.

Takeda Opens Dengue Vaccine Plant in Germany

Takeda Pharmaceutical Company opened a new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003, the company announced in a Nov. 5, 2019 press release. The plant will be used for formulation, fill/finish, and secondary packaging of the dengue vaccine candidate. Initial construction activities started at the end of 2016 and the plant is now ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure. Takeda invested more than 130 million Euro (more than $143 million USD) and will employ up to 200 employees in the vaccine plant.

“This project is one of our most significant investments within our global manufacturing network. We are proud to open this new, state of the art sterile manufacturing plant, which combines a high degree of automation with the most advanced digital and data-driven technologies,” said Thomas Wozniewski, global manufacturing and supply officer. “Our Singen site has been selected for this investment as our employees have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine candidate.”

“This new production facility expands Takeda’s global footprint in vaccine manufacturing beyond Hikari, Japan and reinforces our capability to manufacture at scale and meet the global demand that we anticipate for this vaccine,” said Rajeev Venkayya, MD, president of the Global Vaccine Business Unit at Takeda.

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus. According to Takeda, Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well tolerated. Takeda announced the trial met the primary efficacy endpoint in January 2019. In a Nov. 6, 2019 press release, Takeda announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of TAK-003 showed that it demonstrated protection against virologically-confirmed dengue (VCD) in children ages four to 16 years. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.

Symbiosis Invests in UK Sterile Biologics Facility Expansion

UK-based CMO has expanded its Scottish facility driven by the market growth of ATMPs such as viral vector and other biopharmaceuticals

Sterile manufacturing specialist and CMO Symbiosis Pharmaceutical Services has expanded its sterile biologics manufacturing facility in the UK by 25%.

In the last 12 months Symbiosis has invested over $1.9 million in the expansion of its Stirling site, doubling its current footprint with an additional 8,000 sq. ft. of office space to house the firm’s administrative, management and operational teams while also facilitating the expansion of its existing manufacturing space and its supporting services infrastructure.

The new operational area also provides additional capacity for GMP-compliant manufacturing services for improved supply chain management including additional temperature controlled storage and the company’s first automated labelling and packaging equipment.

Colin MacKay, CEO at Symbiosis said: “This represents another exciting step for Symbiosis which allows the company to continue to leverage its expertise in small scale clinical and commercial sterile manufacturing to drive future growth.”

MacKay explained that the additional space has allowed the company to increase its headcount from 60 to 90 employees.

“The investment in the new facility is driven by the significant organic growth of the company as a result of its continued success in the niche market of sterile manufacturing of advanced therapeutic medicinal products (ATMPs) such as viral vector and other biopharmaceuticals - our customer base has grown by more than 25% in 2019 alone.”

The expanded facility, which was recently completed and is now fully operational, has been part-funded by a successful Innovate UK grant from the UK Government aimed directly at strengthening the UK’s viral vector biopharmaceutical drug development and manufacturing supply chain. The continued investment and demand for services is estimated to increase output by another 25-30% in 2020.

Colin MacKay continued: “The strategic focus of Symbiosis for 2020 is on the continued organic growth of our core sterile GMP manufacturing services in our key target markets in the US and Europe. Expanding the level of viral vector sterile manufacturing is central to that strategy, and we have a number of new and current client project initiatives which are further driving that expansion.”

As well as the growth of its specialist viral vector filling services, Symbiosis services the demand for sterile fill-finish of conventional small molecule drugs in both liquid and lyophilized formulations for clinical trials, and also has experience of supporting fast-track international commercial product registration.

HALIX cGMP Biopharmaceutical Facility, Leiden

HALIX inaugurated its new current good manufacturing practice (cGMP) biopharmaceutical manufacturing facility at the Leiden Bioscience Park, Netherlands, in November 2019.

The facility produces viral and protein products. Construction on the facility began with the ground-breaking ceremony that took place at the site in July 2018, with completion in August 2019.

HALIX intends to use the facility for the development and production of biopharmaceutical drug substances and client-specific technologies.

The Leiden Bio Science Park in the Netherlands was selected as the strategic location for the cGMP facility as it is the largest science cluster in the Netherlands. It is home to 150 companies, 14 health care organizations, 11 research institutes and 11 educational centers.

The location offers a skilled workforce and state-of-the-art research facilities. The facility is well-connected to other parts of the country, as the area is close to the A44 motorway.

The cGMP facility occupies 6,700m² of space at the Leiden Bioscience Park. The building has four floors with each floor offering an area of 1,290m².

Its ground floor accommodates workplace areas, assembly rooms and the warehouse, while the first floor houses viral products manufacturing areas and laboratories. Protein manufacturing facilities are located on the second floor, whereas the third and fourth floors feature an expansion area reserved for future manufacturing needs.

The GMP facility focusses on project segregation by employing innovative concepts such as uni-directional process flow, single-pass air, pest control at change-over, interlock and security systems.

It also supports future expansions and offers flexibility for cGMP manufacturing solutions for viral products, proteins, gene therapy and client-specific technologies.

A 1,400m² area is reserved for future expansion for the production of therapeutic proteins and viral vaccines on a large scale. The building also offers space for logistics.

The biopharmaceutical facility contains a state-of-the-art manufacturing line for viral vaccines and vectors with an initial bioreactor volume of 250l. It also features a dedicated area for single-use bioreactors with a maximum capacity of 1,000l.

The laboratory area at the production facility supports process development and transfer, as well as analytical development and quality control of biopharmaceuticals.

Prepared for an upgrade from BSL2 to BSL3, the cleanrooms with a unidirectional process flow ensure commercial production of biopharmaceuticals. The office space, laboratory and cleanroom area can accommodate up to 70 employees.

The contract for the design of the GMP production facility was awarded to EGM architecten & DuPrie in 2018, while Kuijpers was selected as the main contractor for the project.

Cleanroom Combination Group delivered cleanrooms for the facility.

Marketing commentary on HALIX:

Founded in 2012, HALIX is a leading contract development and manufacturing organization (CDMO) for GMP manufacturing of biologics.

Headquartered in Leiden, the Netherlands, HALIX is a spin-off of HAL Allergy, who are both owned by Droege Group.

With the prevalence of the Chikungunya and Zika virus in Africa and South America, HALIX ventured into the production of vaccines for the prevention of infectious and viral diseases. The company also focuses on therapeutic vaccines for the prevention of cancer.

HALIX provides end-to-end services to new and existing B2B customers from the initial developmental commercial stage to successful registration of products. The company is licensed for clinical and commercial GMP contract manufacturing of biopharmaceuticals.

Novartis Stein Cell and Gene Therapy Facility

Novartis opened its new cell and gene therapy facility in Stein, Switzerland, in November 2019, intending to support the production of innovative medicines.

Construction of the facility began in 2012 to manufacture solid medications for the company’s Innovative Medicine division. Its estimated investment is CHF90m ($91m).

Novartis received the approval for its first CAR-T cell therapy, both a cell and gene therapy, in 2017.

In April 2019, the company completed the acquisition of CELLforCURE, contract development and manufacturing organization (CDMO), to scale-up its CAR-T cell therapy manufacturing capacity, as well as other cell and gene therapies in the pipeline.

The facility completed the first clinical production of cell and gene therapy batch in September 2019.

The cell and gene therapy manufacturing site is located approximately 30km away from Basel, in northerly cantons of Aargau, Switzerland.

Novartis also operates two more facilities at Stein for manufacturing solid and sterile dosage forms. The two existing facilities export more than two billion vials, auto-injectors, pre-filled syringes, ampoules, capsules and tablets to more than 150 countries worldwide.

The Stein site is the most strategic site for manufacturing and finishing of inventive medications for the company. It will play a significant role in the production of difficult-to-manufacture solid and liquid dosage forms.

The biotechnology center is used for the formulation of tablets, capsules, active pharmaceutical ingredients (APIs), transdermal patches, sterile vials, pre-filled syringes, inhalations and ampoules.

The site receives blood cell samples of patients for the enrichment and genetic modification of leukocytes and lymphocytes to restore their cancer-fighting ability. The reformed cells are then sent to a hospital to inject into patient’s blood.

Stein site also manufactures novel CAR-T cell therapy Kymriah® to treat B-cell lymphoma. The first batches of Kymriah from the facility will be launched in the market in 2020.

Cell and gene therapies involve altering and inserting cells and genes into specific cells. Treatments are intended to prevent, treat and cure genetic and acquired diseases.

Cell therapy treats diseases by reinstating and changing the particular sets of cells, using them to deliver treatment through the body.

The cells are cultured or altered outside the patient’s body before they are injected into the body and can be collected from patient (autologous cells) or donor (allogeneic cells).

Gene therapy re-establishes, deactivates or introduces genes into the cells through in vivo (inside the body) or ex vivo (outside the body) methods.

Marketing commentary on Novartis:

Novartis is a global healthcare company based in Basel, Switzerland and is one of the biggest pharmaceutical companies by market capitalization and sales. The company operates through three major business units, Alcon, Sandoz and Innovative Medicines.

The company is currently focused on developing innovative medicines for the transformation of cancer care and has more than 200 drug candidates in its clinical pipeline, exporting its products to 155 countries.

Focus therapeutic areas of Novartis are oncology, dermatology, immunology, ophthalmology, respiratory, hepatology and cardiovascular.

Sartorius, German AI Research Center Launch Research Lab

Alliance aims to develop and employ machine learning and image and pattern recognition processes

Sartorius and the German Research Center for Artificial Intelligence (DFKI) have established the Sartorius AI Lab (SAIL) research lab on the DFKI campus in Kaiserslautern. The lab will use artificial intelligence (AI) in Sartorius products and platform solutions being experimentally tested and further developed at SAIL.

“So far, advanced methods of data analysis have been used only to a very limited extent in the biopharmaceutical industry, in drug research and in production. This is one of the reasons that development timelines and costs for medical drugs are ever increasing. Better use of data through AI is a particularly promising approach for making significant progress in this area. Many customers are already using the powerful software we have been offering for two and a half years through our Data Analytics unit for specific applications in biopharmaceutical production. We aim to strongly expand this business activity and are therefore glad to have found DFKI, one of the most important international centers of excellence for AI and deep learning with more than 1,000 scientists, as strong partners to join us in developing such solutions,” said chief executive officer Dr. Joachim Kreuzburg.

SAIL is assigned to the DFKI research department of Smart Data & Knowledge Services headed by Professor Andreas Dengel and uses DFKI's deep learning hardware and expertise, which is unique throughout Europe. As a protected data room and independent data laboratory, SAIL is also open to Sartorius partners and customers as part of cooperation agreements, and the first projects have already been initiated. In addition, Sartorius and DFKI will use SAIL for training purposes, and DFKI employees will also be able to further their education in life science applications at Sartorius research sites.

Sartorius and DFKI intend to develop and employ machine learning and image and pattern recognition processes, among other technologies, for life science applications. For example, their researchers are working on new deep learning algorithms and methods for image recognition of cells and organoids, analysis and modeling of biological systems and for simulation and optimization of biopharmaceutical production processes. Sartorius provides extensive data for this purpose and sends specialists from its Corporate Research and Product Development units to SAIL.

Andreas Dengel, DFKI site manager in Kaiserslautern, said, "The DFKI transfer labs are developing new service modules with artificial intelligence for various markets and target groups. For two years, we have been using our AI hardware equipment, which is unique in Europe, for application-oriented research we conduct together with renowned companies such as Allianz, Continental, Hitachi and IAV. I am very pleased that we are entering the life science tools market as a partner with the global player Sartorius."

CDMO JOINN Biologics to Build Biotech Plant

Last year, US-Chinese contract development and manufacturing organization (CDMO) JOINN Biologics spun off from its parent company. The split, which separated the CDMO from preclinical contract research organization JOINN Laboratories, set the spinout up to focus squarely on becoming a leader in the outsourced development and manufacturing space.

Now, JOINN Biologics has raised money to fund its push to achieve that goal. The money will support the construction of a 100,000L capacity biologics manufacturing facility in Beijing, China.

Building the plant will add to JOINN Biologics’ existing capacity. The CDMO works out of a site in California that houses 200L and 500L single-use bioreactors, as well as 50L, 200L and 1,000L stainless steel bioreactors.

JOINN Biologics also has two 200L and two 500L bioreactors at a site in China, giving it the capacity to support drug developers in two key biotech markets.

The new Beijing facility will operate on a bigger scale, positioning JOINN Biologics to compete with the leading biologics CDMOs for larger, later-stage production contracts. That reflects JOINN Biologics’ aspiration to work across the product life cycle, from preclinical through to commercial production, but puts it in competition with well-established and emerging rivals such as Catalant, Lonza, Samsung BioLogics and WuXi Biologics.

Investors including HG Capital, Nestbio Capital, Hong Kong LINKAGE Holdings and Xiangtang Capital have signed up to bankroll JOINN Biologics’ attempt to realize that aspiration, putting together a $60m (€54m) investment package.

The money will primarily support the construction of the Beijing biologics plant but JOINN Biologics thinks it will have enough left over to fund other activities. JOINN Biologics plans to use some of the money to expand its business in China and the US.

Responsibility for investing the money will fall on a leadership team with experience working at some big companies. Co-founder Tao He spent time at Novartis and Pfizer earlier in his career, while other members of the management team list stints at Bayer, Boehringer Ingelheim, Catalant and Merck on their résumés. The leadership team sits above a 200-strong organization spanning the US and China.

Micronclean: Construction of Cleanroom Laundry in Bangalore Progresses

Statement from the UK contamination control specialist details advances in the construction project of its cleanroom garment laundry in India.

It is important to the build project, to the construction workers, and to Micronclean India employees, that we follow traditional rituals performed when building a factory in India.

A "pooja" is an act of worship. This groundbreaking pooja was conducted prior to digging the foundations. It is recommended in the traditional Indian system of architecture – the Vastu Shastra, which gives guidance on how to integrate architecture with nature.

The ceremony is designed to bless the land and to give the people running the project the confidence that they will succeed. The same guidance is used when building homes, temples and even entire cities.

The factory build process is well underway. The laundry building has been constructed. The cladding is now almost complete, the mezzanine floor has been constructed, and internal works are underway (e.g. laying drains, installing sprinkler system).

The secondary buildings have also been constructed. Of these, the most important is the large utilities building. This will house key equipment and machinery including the electrical transformers, boilers and the water recycling system.

During the final week of August, the first items of equipment were delivered to site. The boiler arrived, and the cleanroom air ducting was delivered. Equipment will arrive thick and fast over the coming months. One of the key challenges on site will then be the coordination of the various contractors to ensure that installation is achieved accurately and efficiently.

The build process has proceeded broadly according to plan. As things stand, Micronclean expect to have the factory handed over for commissioning and validation in January 2020, and hope to be operational by April 2020.

Cellular plant design

The company will be implementing a new plant layout in the Micronclean India facility. The plant is designed in a cellular layout. One production cell will handle a given set of batches, and individual batches will not be mixed within the cell. A batch will be made up at goods in.

There will be no storage of work in progress at any point midway through the process. A line clearance is completed at each step to ensure the garments in the batch remain together, and the next batch can only be handled at that step once the line clearance for the previous batch has been completed. This is an example of a 'pull' process.

Micronclean hope this will make for a more organized, more efficient production environment.

In the UK, Micronclean uses gamma irradiation to sterilize garments. In India we will use a different sterilization technology – steam sterilization using autoclaves.

The autoclaves will be 'pass through' type, built into the wall of the cleanroom between the main cleanroom and the packing area.

Once garments are folded and packaged, they will be loaded into a trolley. The trolley is wheeled into the autoclave, the door closes, and the sterilization process will take place. Once complete, the door on the packing room side will open, the trolley wheeled out, and the garments will be unloaded for secondary packaging, labelling and sorting.

This technology will allow us to take responsibility for garment sterilization and will reduce overall turnaround time for sterile garments. We also expect that steam sterilization will be less damaging to garments when compared with irradiation, so garment life might increase.

Semi-automatic sorting

One of the challenges the company will face in operating a factory in India is the variety of languages that might be spoken by people in the plant. To overcome this, it decided to plan to work instructions and Protrack software as visual as possible, minimizing the use of text.

One area in which this will be apparent in the laundry is the garment sorting process. Much like in the Skegness cleanroom laundry, there will be a packing cleanroom in which garments will be sorted and loaded into hampers ready for dispatch.

To increase the efficiency and accuracy of this process without using language, there will be a semi-automatic sorting process implemented. This will consist of a number of ‘bins’ that garments will be sorted into according to customer requirement prior to bagging up.

Protrack has been adapted so that, when a garment is scanned at the sorting station, it illuminates a light above the correct sorting bin. We hope that this system will be easy to train operators to use and should allow them to perform the sorting task quickly and accurately without the need to read text instructions.

Water recycling

Availability of sufficient, clean water is a severe environmental issue in India. As people from the countryside move to the cities, demand for water in cities is growing very rapidly. In some parts of the country, there is not enough safe water, therefore the government is having to implement emergency plans to assure future water supply.

One key government initiative is to encourage new build factories to implement water sustainability measures. This has led us to investigate the opportunity to recycle the water we use.

Laundry is a naturally water-intensive industry, and therefore it is important we take the issue seriously and find out how we can be more sustainable. We have worked with water system suppliers to develop a water recycling system that will allow us to reuse more than 90% of the effluent that would normally go down the drain.

The system will take the effluent from the drain channel, will pass this through a heat exchanger (to recover as much of the energy as possible – also great for sustainability!), and then it will be passed through several stages of treatment – chemical, biological, filtration, and then several stages of reverse osmosis. This will allow us to recover the majority of the water we use back to a suitable quality to use in our process.

It will be challenging to optimize this water system when the plant becomes operational. However, we are very excited about this development. If it works, then there might be an opportunity to bring similar ideas to our UK facilities.

Official Launch of Sino-Singapore Biotech Hub in Lushunkou, Dalian

On the morning of December 22, the official launch ceremony of Sino-Singapore Biotech Hub was held at Grand Hyatt Hotel, Dalian. The project construction is scheduled to start in March 2020 and targeted to be available for biotechnology transformation, research and development and ready for manufacturing processes and production by end of 2020. The Biotech Hub project totals an investment of RMB1.9 billion yuan, covers a total area of 355,080 sq. ft. (33,000 square meters) with a construction area of 306,660 sq. ft. (28,500 square meters). Through Biosyngen Group acting as the bridge, it opens the gateway of biomedical technology and products from Singapore, Europe and Australia to achieve commercial development of biotech technologies, production and sales in China.

At the official launch ceremony, the Lushunkou District Government and Stone Capital jointly signed a Memorandum of Understanding (MOU) of Healthcare Fund to raise an investment of RMB 2 billion yuan, and the headquarter of Biosyngen China is inaugurated. To commemorate this special occasion, the organizer was delighted to have presence of the following honorable guests: Mr. Zuojun Tan, Member of CPC Liaoning Provincial Committee and Secretary of Dalian Municipal Committee, Mr. Guowei Jin, Deputy Mayor of Dalian Municipal Government, Mr. Hongwei Zhao, Secretary of CPC Lushunkou District Committee; Directors of various departments of Dalian Municipal Government who helped in preparation and support of Biotech Hub; leaders of Affiliated Hospital of Dalian Medical University, Mr. Frank Wang, Dr. Lietao Li, Mr. Feiyu Shen, Board Member of Biosyngen Group, Prof. Wanjin Hong, Executive Director of IMCB Singapore, Mr. Liqun Wang, from Stone Capital, Ms. Alice Chen, and Mr. Jun Shen from ABC Capital.

Dalian Sino-Singapore Biotech Hub, located near Dalian Medical University and Dalian University of Foreign Languages in Lushunkou district, is listed as one of 2019 key projects of Dalian Government for the city. The launch of the Biotech Hub is a concrete step for building a landmark project of the healthcare industry in Northeast Asia. It took a total of 266 days from the first visit of Mr. Zuojun Tan's to Biosyngen China on March 31st, to the official launch held on Dec 22nd. On July 29, 2018, the Biotech Hub agreement was signed and witnessed by Mr. Yijun Tang, Liaoning Governor and Mr. Masagos Zulkifli, Minister for the Environment and Water Resources of Singapore. During this period and under guidance of Mr. Guowei Jin, Dalian Deputy Mayor, both Biosyngen and Dalian government have interacted and discussed over 50 times. As expressed by Mr. Hongwei Zhao, Secretary of CPC Lushunkou District Committee, "This project signifies the full and efficient support of all departments of the municipal government, including the guidance of the leaders of Dalian Medical University, and the sincere cooperation between Biosyngen Group and our district". Dr. Victor Li, Founder and CEO of Biosyngen Group, said, "With the continued strong support of Singapore government, Agency of Science, Technology and Research (A*STAR) and Institute of Molecular Cell Biology (IMCB), Biosyngen Group will draw on Sino-Singapore Dalian Biotech Hub as a base, conduct in-depth research cooperation and leverage on medical resources from Dalian Medical University, to accelerate the commercialization of biotechnology products in China."

Mr. Liqun Wang, Founder and Chairman of Stone Capital and Director on Board of Biosyngen Group, said, "In order to improve efficiency, Stone Capital has set up a Biotech fund in Singapore, called, BioSyn-Stone Capital (USD 50 million fund for early stage biomedical projects). "With assistance of the provincial and municipal industry guided funds of Liaoning Province and Dalian, Stone Capital will build a healthcare fund of RMB 2 billion yuan, which will further facilitate the settlement and growth of pharmaceutical and biological companies (including Singapore companies) in the Dalian Sino-Singapore Biotech Hub.

Official Launch of Sino-Singapore Biotech Hub First Row Middle: Mr. Guowei Jin, Deputy Mayor of Dalian Municipal Government 1st from left: Dr. Victor Li, Founder and CEO of Biosyngen Group 2nd from left: Prof. Wanjin Hong, Executive Director of IMCB Singapore 2nd from right: Mr. Frank Wang, Chairman of Biosyngen Group 1st from right: Mr. Liqun Wang, founder and chairman of Stone Capital.

Sekisui Diagnostics Opens Bioprocess Innovation Center

The facility, which more than doubled R&D lab space to facilitate process transfer and development, also includes dedicated and separate microbial fermentation development, protein purification, analysis, and molecular biology laboratories.

Sekisui Diagnostics’ Enzyme business unveiled its new Bioprocess Innovation Center at its site near Maidstone, Kent, UK. The new R&D facility, costing $1.9 million, is part of a long-term investment strategy to grow its share of the microbial biopharma CDMO market, with future investment expected to focus on expanding its current good manufacturing practice (cGMP) manufacturing capabilities, starting with additional ISO 8 cleanroom capacity that was expected to come online by the end of 2019, according to company officials.

The Center includes 2,690 sq. ft. (250m2) of laboratory space and 1,442 sq. ft. (134m2) of office space, more than doubling its R&D laboratory space to facilitate process transfer and development.

Sekisui’s biopharma CDMO service offering, BioProduction by Sekisui, is focused on expression and purification from microbial fermentation. Building on over 40 years’ experience in this field, the group’s expertise lies in the production of enzymes, says Will Stockburn, Sekisui Diagnostics’ general manager, adding that its capabilities are also suitable for plasmids, antibody fragments, and other protein production.

“This investment represents our commitment to serve our customers with innovative process development solutions,” noted Stockburn. “Over many years we have built a technical competency in enzyme production process development. The new facility will enable our team to attract more customers as the biopharma CDMO market grows.”

WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility

STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This marks WuXi STA’s establishment of a one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around the world to advance promising new oligonucleotide therapies more rapidly to market for the benefit of patients.

The new facility, with over 30,000 square feet, is located at WuXi STA’s Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers.

WuXi STA’s platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company’s industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development.

“By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide,” said Dr. Minzhang Chen, CEO of WuXi STA.

WuXi Biologics Buys Bayer Site in Germany

First drug product facility in Europe to complement WuXi Biologics’ existing commercial manufacturing capacities.

WuXi Biologics and Bayer have entered an acquisition agreement in which WuXi Biologics Germany GmbH will take over the operations of one of Bayer’s final drug product manufacturing plants in Leverkusen, Germany, and purchase the associated equipment, in combination with a long-term lease contract for the building.

Based on a manufacturing agreement to be negotiated, the plant would be operated by WuXi Biologics and serve as a back-up site for the final product manufacturing of Kovaltry, an antihemophilic factor (recombinant). The transaction is expected to be concluded in the coming months subject to the satisfaction of customary closing conditions. Financial details were not disclosed.

“We are excited to sign this acquisition agreement with Bayer, allowing us to have quick access to high quality drug product manufacturing capacities and capabilities,” said Chris Chen, chief executive officer, WuXi Biologics. “Our business in the EU, U.S. and China market has experienced robust growth in the past few years. This additional drug product plant further confirms our commitment to ‘Global Dual Sourcing within WuXi Biologics’ strategy. WuXi Biologics will continue to expand our worldwide capacity, providing global partners with a robust and premier-quality supply chain network to benefit patients worldwide.”

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com