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The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Gilead Sciences and Kite to Acquire Cell Design Labs

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Biocad Announces New Manufacturing Site in North Africa

Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma. 

Binding Site Expands mAb Portfolio

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

GE Healthcare Completes Acquisition of Bioprocessing Start-Up

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe. 

Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

Drug Substance Analysis