The latest news from CDMOs, CMOs, and suppliers featuring news from AGC Biologics, Avantor, Fujifilm, Sartorius, AMRI, Symbiosis and PCI Pharma.

Biologics Manufacturing

AGC Biologics To Expand Plasmid DNA Offering

AGC Biologics, a CDMO for protein-based therapeutics, is expanding its CDMO services with plasmid DNA (pDNA) offerings from its site in Heidelberg, Germany. 

The pDNA have been used for many years in the manufacturing of DNA adjuvants and vaccines and as a starting material for RNA drugs and cell-free protein expression platforms. However, in more recent years, pDNA has been key for gene-therapy applications for the creation of lentivirus and adeno-associated viruses as well as direct gene therapy.

AGC Biologics’ facility in Heidelberg, Germany has been manufacturing pDNA for 10 years. Currently, the site has completed a pDNA manufacturing process improvement project that enables the extension of the offer in hosts and plasmids (low and high copy pDNA expression systems) via a large toolbox in process development with scales of 1 L to 10 L for high-quality pDNA. These processes can be scaled up to fit into the established 50 L, 100 L, 500 L or 1,000 L GMP manufacturing.

AGC Biologics currently has microbial facilities in Heidelberg, Germany, Copenhagen, Denmark, Chiba, Japan and soon an additional microbial facility in Seattle, Washington.

Source: AGC Biologics

Avantor Sciences Opens Innovation and Customer Center in China

Avantor, a provider of products and services for life sciences and advanced technologies industries, has opened an innovation and customer support center in Shanghai, China for biopharma research and technology development. Avantor now has nine innovation centers around the world.

The new Avantor laboratory will specifically focus on enhancing industry capabilities in the development and manufacture of biological medicines such as monoclonal antibodies and cell and gene therapy. It will offer professional guidance on regulatory matters and training on chromatography process optimization and materials qualification, support proof-of-concept trials to reduce process optimization delays, and provide access to a portfolio of production solutions and single-use solutions.

The center will support biopharma companies by providing access to products, services, solutions and expertise for all stages of development, from the small-scale bench to pilot plant and full commercial biomanufacturing. It will focus on optimizing monoclonal antibodies purification processes and accelerate capabilities in raw material testing and qualification for cell and gene therapy.

Avantor opened the region’s first innovation center in Taiwan, China in 2010. The company also has other innovation centers in GwangGyo, South Korea, Mumbai, India and Dehradun, India.

Source: Avantor Sciences

Fujifilm Establishes Bio Science and Engineering Labs in US

Fujifilm Corporation has begun full-scale research activities in the field of translational research for biotherapeutics at its newly established Bio Science & Engineering Laboratories U.S.A. in Madison, Wisconsin to strengthen its fundamental research efforts to support gene therapy, cell therapy and regenerative medicine applications.

The US Bio Center is a research hub that conducts early-stage fundamental research through production process development in addition to translational research for new drug-discovery support solutions using induced pluripotent stem cells (iPSCs). The company will further add to its research capabilities through its two research hubs in Japan and the United States. The US Bio Center will collaborate with the Bio Science & Engineering Center in Japan to promote advanced research on a global scale.

Using the company’s image analysis technology, as well as artificial intelligence and information and communication technologies, Fujifilm will conduct research utilizing bio-informatics, including cellular metabolism and gene expression, cell-engineering such as genome editing technology, manufacturing automation technology, and new drug-discovery support technology using iPSCs.

Prior to the establishment of the US Bio Center in March 2018, the company brought together its cell researchers and production process developers to establish the Japan Bio Center in the Fujifilm Advanced Research Laboratories (Kanagawa Prefecture). With its structure focusing on fundamental cell research through to the development of mass production technology required for commercial products, the Japan Bio Center promotes research and development for cell-culture processes, specific to various cell types, and achieving mass production of cultured cells. The company has also been conducting research through combining proprietary technologies and knowledge of group companies, including Fujifilm Diosynth Biotechnologies, its biologics CDMO, Fujifilm Cellular Dynamics, in the field of iPSC development and manufacturing, Fujifilm Irvine Scientific, a developer and manufacturer of cell-culture media, Fujifilm Wako Pure Chemical Corporation, a laboratory chemical company and Japan Tissue Engineering Co. Ltd., focused on commercializing regenerative medicine products in Japan.

Source: Fujifilm Corporation

Sartorius Acquires Majority Stake in Israeli Biological Industries

Sartorius Stedim Biotech has agreed to acquire a majority stake in the Israeli cell-culture media developer and manufacturer, Biological Industries, for approximately EUR 45 million ($50 million) in cash, Sartorius is acquiring just over 50% of the shares of the company from its owners, Kibbutz Beit Haemek and the private-equity fund,Fortissimo Capital.

Sartorius also agreed to an option to acquire a further 20% of the shares within three years. Biological Industries focuses on cell-culture media, particularly for cell and gene therapy, regenerative medicine, and other advanced therapies. 

Biological Industries currently employs approximately 130 people mainly at its headquarters, research, development and manufacturing site close to Haifa, Israel, and at sales locations in the US, Europe and China. Cell culture media are used in research, clinical development and production of biopharmaceuticals as well as in cell and tissue therapy applications. The company offers  media solutions, including a portfolio of clinical-grade media for cultivating cells and stem cells and for cryopreservation, applications that are both relevant in advanced therapy research and clinical development. In addition, Biological Industries provides cell-culture reagents as well as classical and serum-free media.

The transaction is subject to customary closing conditions and was expected to be finalized by mid-December.

Source: Sartorius Stedim Biotech

Formulation Development/Drug-Product Manufacturing

Symbiosis Invests $1.95 Million in UK Facility Expansion

Symbiosis Pharmaceutical Services, a sterile CMO, has expanded its sterile biologics manufacturing facility in Stirling, Scotland, UK by 25%, investing over £1.5 million ($1.95 million) in the last 12 months.

Symbiosis has doubled its current footprint with an additional 8,000 square feet of office space to house the company’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 labeling and packaging equipment.

Symbiosis also has a facility in Cambridge, Massachusetts, supporting both pharmaceutical and biotechnology companies with its vial-filling expertise and small-scale aseptic manufacturing capabilities.

Source: Symbiosis Pharmaceutical Services 

PCI Pharma To Invest $12 M to Expand UK Mfg Facility 

PCI Pharma Services has begun an expansion of its Tredegar facility in Wales, UK to enhance its drug manufacturing and development capabilities for  both clinical and commercial supply.

The investment involves an extension to the contained oral solid dosage form manufacturing facility that will double the large-scale granulation and fluid-bed drying capacity. It will also create additional space for new capabilities and a small-scale processing area to allow early-stage non-GMP processing and formulation. The investment in Tredegar follows news earlier this month of the completed expansion to its Rockford, Illinois facility to include over 30,000 square feet dedicated to specialty drug product capabilities, with four high potent compound capable suites and three new secondary packaging areas.

The new space is expected to be operational in the first half of 2022.

Source: PCI Pharma Services

General

AMRI Appoints New CEO

AMRI has named John Ratliff as Chief Executive Officer (CEO), effective December 2, 2019. Mr. Ratliff succeeds Michael Mulhern, who has been appointed as Chairman of the AMRI Board of Directors.

Mr. Ratliff previously served as CEO of Covance, a $4.3-billion drug-development business within LabCorp, and has more than two decades of experience in the pharmaceutical and life sciences industry. Prior to LabCorp, he served as CEO of HUYA Biosciences, a global biopharma innovation company. Ratliff also served in various roles at Quintiles, a global pharmaceutical services provider, including as Chief Financial Officer, Chief Operating Officer, and President. Ratliff graduated from The Georgia Institute of Technology with a Bachelor of Science in industrial and systems engineering and holds an MBA from Duke University.

Source: AMRI