Sunday, June 2, 2019 Daily Archives

Making rare disease successes more common

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Complex pathologies and small patient populations make rare disease R&D difficult according to Alexion, which says recent FDA guidelines are welcome. At large biopharma firms, rare disease drug R&D projects are becoming common. Their high revenue potential combined with IP advantages afforded to such products makes them an attractive focus for developers. For example, orphan drug designation entitles firms to reduced fees, tax breaks for trials and extended market exclusivity. Investors also welcome such designation. According to one study, developers…

June 2, 2019

PE to boost Vibalogics’ viral vector capabilities

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Private equity firm Ampersand Capital Partners has bought CDMO Vibalogics and intends to expand its capabilities to service the demand for gene therapy services. The price of the German contract development and manufacturing organization (CDMO) has not been disclosed, but Ampersand’s acquisition will help widen Vibalogics’ global reach on the back of increased demand for viral vector and gene therapy services. “Vibalogics can now strengthen and expand the position in both of its home markets, the USA and Europe, as…

June 2, 2019

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

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Do not confuse the methods and purposes for controlling the serum supply chain by misleading end-users into believing that some origins of serum are better and safer than others, says the European Serum Products Association (ESPA). Last month, Bioprocess Insider published an article entitled: ‘Quality FBS, or just BS? Industry turning to supply chain certification’. The article detailed a presentation from the International Serum Industry Association (ISIA) at BPI Europe in Vienna, Austria and highlighted the application of independent audits,…

June 2, 2019

Affibody contracts 3P for psoriasis protein scale-up

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Contract development and manufacturing organization (CDMO) 3P Biopharmaceuticals will scale-up the manufacture of Affibody’s candidate ABY-035 for psoriasis. Swedish biopharma firm Affibody has been working with 3P since 2017 and has now secured the CDMO to transfer and scale-up the process developed prior to execution of the first GMP manufacturing batches for its candidate ABY-035. 3P will also carry out process characterization and validation ahead of commercial manufacture. “Currently the collaboration is based on GMP manufacturing for Ph II clinical…

June 2, 2019

Partnerships abet vendors in tackling cell & gene logistics and automation

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With Thermo Fisher teaming with automated tech company Scinogy and GE Healthcare collaborating with logistics firm World Courier, both vendors have increased their advanced therapy services. The recent approval of Novartis’ one-off gene therapy Zolgensma (onasemnogene abeparvovec) has cemented the advent of advanced therapies. With hundreds more cell and gene therapies in development, the US FDA has predicted that up to 20 such products will be approved each year by 2025. Vendors, therefore, have been increasing their commercial services technologies…

June 2, 2019