Contract Manufacturing, Biopharmaceutical Production

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

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

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

A new facility type integrates next-generation mobile cleanroom systems.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

Innovation speeds discovery, drives down costs, and improves productivity.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Cold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

At DCAT's annual meeting, Bill Downey, president of the market research firm High Tech Business Decisions, summarized results from its latest survey on biopharmaceutical outsourcing.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

Expansions at Catalent’s Kansas City, MO, and Madison, WI facilities made in response to industry demand.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.

Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association speaks with Pharmaceutical Technology.

The 12th Annual Report and Survey of Biomanufacturing is now available.

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.