Tuesday, December 18, 2018 Daily Archives

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

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In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…

December 18, 2018

Rentschler buying Shire hemophilia plant in MA

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Rentschler Biopharma will produce recombinant hemophilia A product Obizur for Shire after acquiring the Milford facility. German contract development and manufacturing organization (CDMO) Rentschler has entered into an agreement to buy Shire’s Milford, Massachusetts manufacturing facility. The facility makes Shire’s approved product Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence], and under terms of the deal Rentschler will take over production and supply directly to Shire from the plant. Financial details have not been disclosed. “Milford is a specialized site that focuses…

December 18, 2018

Global biologics demand driving MabPlex expansions

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MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…

December 18, 2018

Teva two: FDA approves Celltrion-made Herceptin biosimilar

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The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

December 18, 2018