Contract Manufacturing, Biopharmaceutical Production

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

The partnership will provide cost effective biologics for the world market.

The joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.

CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

The company has launched new services for mammalian cell bank manufacturing under GMP conditions.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

Think ahead to production requirements when planning strategies in early development of gene and cell therapies.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

Alcami Biologics formed to meet market demands for biological drug development services.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.