Contract Manufacturing, Biopharmaceutical Production

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

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 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.

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

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

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

BioPharm International spoke with Cindy Reiss-Clark, vice president, general manager, Biologics at West Pharmaceutical Services Inc., about the growing biologics market, specifically gene therapies, and how West is helping their clients prepare for these new trends.

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.

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. 

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.

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.

Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.