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Headlines > August 2017

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Gilead ups capacity with Cali manufacturing facility

18-Aug-2017 - Biopharmaceutical firm Gilead Sciences has opened a facility in La Verne, California, US, which it says will boost manufacturing volumes.

Vendors optimistic for future despite slowdown in growth

18-Aug-2017 - Bioprocessing suppliers have recently expressed optimism in the sector despite a slowdown in growth, and one expert believes this will drive investment in new tech and markets.

ImmunoPrecise acquisition boosts antibody service

17-Aug-2017 - ImmunoPrecise Antibodies has acquired U-Protein Express, enabling it to offer microgram quantities of engineered antibodies to clients.

EMA plans biomarker and drug-matched guidelines

17-Aug-2017 - The European Medicines Agency (EMA) is working on guidelines to help drug firms to develop companion diagnostics in parallel with medicines.

Sanofi and Regeneron end ten-year mAb collaboration

16-Aug-2017 - “One of the most productive arrangements in the history of the biotechnology industry” will end, says Regeneron on its monoclonal antibody collaboration with Sanofi.

Bioproduction bottlenecks increasing due to staff shortages, says report

16-Aug-2017 - A shortage in expertise is causing bottlenecks in the biomanufacturing space with around half of drugmakers struggling to fill processing positions, an industry report finds.

EMA bids to clarify API starting material info pharmas should provide

16-Aug-2017 - The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.

Artificial intelligence R&D to combat age-related diseases

11-Aug-2017 - Researchers from the University of Copenhagen and Insilico Medicine have teamed up to identify compounds for drug development, using artificial intelligence (AI). 

Reprocell grows cell and tissue-based services in Scotland

11-Aug-2017 - Human tissue-focused products and services firm Reprocell Europe has opened headquarters in Glasgow, Scotland, which it says will boost business and create jobs.

Avara agrees to buy ex-Hospira plant in Italy from Pfizer

10-Aug-2017 - Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.

update

Pfizer chooses Sanford, North Carolina site for $100m gene therapy plant

09-Aug-2017 - Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.

‘Origami pacman’ tech could help drug firms handle single-cells, say researchers

09-Aug-2017 - Researchers at US-based North Carolina State University and Duke University have developed a ‘microbot’ which they say could capture and transport single-cells for drug production.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 - The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

update

Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 - Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK....

Trellis selects CMC Biologics to make mAb therapies

08-Aug-2017 - CMC Biologics and Trellis Bioscience are teaming up to make monoclonal antibody (mAb)-based therapies.

US FDA finds faults at Biocon plant slammed by French regulators in July

07-Aug-2017 - The US FDA has issued Biocon with a Form 483 detailing problems inspectors identified at a plant in Bangalore, India.

Kite assesses EU manufacturing options as it submits CAR-T therapy for review

04-Aug-2017 - Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.

Celltrion Healthcare $890m IPO to up biosimilar inventory and broaden portfolio

04-Aug-2017 - Celltrion Healthcare will purchase more biosimilars from biomanufacturing partner Celltrion Inc. and expand its distribution network after raising one trillion Won ($888m) in an IPO.

Repligen closes Spectrum acquisition in latest boost for filtration business

04-Aug-2017 - Filtration drove a record quarter for Repligen which says the addition of Spectrum Pharmaceuticals will further grow its bioprocessing portfolio and geographical presence.

Biosimilar boost for Pfizer but Inflectra takes just 2.3% of US infliximab market

04-Aug-2017 - Pfizer saw a 60% year-on-year growth in sales from its biosimilar products but Inflectra penetration in the US was lower than expected.

Comment

Modular single-use facilities rebalance Biopharma’s capacity scales

02-Aug-2017 - Modular facilities and single-use systems are fast becoming a standard part of the bioproduction infrastructure as industry looks to mitigate future capacity constraints.

Horizon cell line sequence released in bid to up bioproduction efficiency

02-Aug-2017 - Horizon Discovery will allow researchers to modify a genome sequence based on its knock-out CHO K1 cell line in a bid to drive innovation in bioproduction.

Seattle Genetics gains first production site through $43m BMS plant buy

02-Aug-2017 - Seattle Genetics paid Bristol-Myers Squibb $17.8m for the biomanufacturing site and says it will spend a further $25.5m on equipment and improvements to support antibody production.

Biotest relocates Florida plasma center, ups workforce

01-Aug-2017 - Biotest Pharmaceuticals Corporation has relocated its Plasma Center in Pembroke Pines, Florida, US.

Thermo Fisher: Modest Q2 for life sciences due to ‘lumpiness’ of bioproduction

01-Aug-2017 - Muted bioproduction technology pegged back an otherwise strong quarter, but Thermo Fisher says it expects growth will pick up again over time.

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