Contract Manufacturing, Biopharmaceutical Production

AzarGen’s biosimilar, made in iBio’s plant-based system, will be compared to the original molecule in pre-clinical studies.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.

CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

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.