Entries by Thomas Gabrielczyk

Preparing for the next generation of biologics

Biomanufacturing?While the FDA and EMA have for the first time okayed the switch from batch to continuous manufacture of a pill – Janssen Cilag’s HIV protease inhibitor darunavir (Prezista) – the
industry is still waiting for such a signal in the biologics field. The FDA wants to boost adoption, and biopharma majors, such as Novartis, Amgen and Biogen, launched a pilot project to lay the groundwork for the next generation of production: continous USP and DSP, and alternatives to CHO cells.

Expanding scale and reach

Flexible and reliable contract manufacturing and development have become the key success factor in the development of biopharmaceuticals. Due to the long process time and high investment needed to build up production capacities, outsourcing of biologics manufacturing provides both access to advanced technologies and necessary capacity along with flexibility in timing and output.

Bayer inks US$1.55bn cancer deal with Loxo Oncology

German Bayer AG has acquired ex-US commercialisation rights to Loxo Oncology Inc’s Phase II lead larotrectinib (LOXO-101), which targets TRK (tropomyosin receptor kinase) fusions in 17 cancer types, and LOXO-195, a Phase I/II compound designed to prevent acquired resistance against larotrectinib.

World Nutrition: Insects will be on every table

Bioeconomy:?It could be a turning point for the fish meal and fish oil dependent animal feed industry in Europe. Since July, the European Commission has allowed the use of insect-processed animal proteins for aquaculture. According to experts, the use of insect meal as a sustainable alternative opens an US$90bn market. 

Bill Gates invests into Alzheimer’s R&D

Billionaire Bill Gates announced he is going to invest US$50m private money into the Dementia Discovery Fund (DDF) to support fresh ideas for developing Alzheimer drugs and diagnostics. The venture capital fund, which kicked off in 2015, includes investors such as GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer and Biogen Idec as well as the UK government.

Rapid implemenation of off-line serialisation

Serialisation of drugs is confronting pharmaceutical companies all over the world with challenges, especially in relation to data handling and the integration of additional equipment and functions into existing packaging lines. Offline solutions, where secondary packaging is serialized directly by the folding-box manufacturer, combined with sophisticated data flow architectures, are a reliable, flexible, and immediately available alternative to inline serialisation.

BIO-Europe more popular than ever

More than 4,000 participants from all over the globe visited Berlin in early November to take part in this year’s BIO-Europe. The event continues to be on the upswing – like the biotech industry itself.