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The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

FDA Accepts Amgen’s Application for New Indication of Osteoporosis Biologic

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

EMA Accepts AstraZeneca’s Application for Lung Cancer Biologic

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

J&J Invests in Biologic Manufacturing Capacity Expansion in Ireland

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

ProBioGen and Chiome in Antibody Manufacturing Deal

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

Amgen to Develop Four Biosimilars in China

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

KBI Biopharma and Heat Biologics Form Manufacturing Pact

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

Drug Substance Analysis