Repligen could reap the financial rewards from two recently approved cholesterol-lowering proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, a Jefferies analyst says.
Shire will use contractors to increase production of Cinryze, the half billion dollar-a-year Hereditary Angioedema (HAE) drug it bought with ViroPharma in 2014.
Sartorius finished the first half of 2015 with increased sales, higher operating profits and a surge in orders that prompted it to raise its full year forecast.
CDMO (contract development and manufacturing organisation) Goodwin Biotechnology is working with CNS biotech Q Therapeutics to produce mAbs for a clinical trial to treat motor neuron disease.
ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.
Biotech company Biogen plans to invest one billion Swiss francs ($1.1bn) in Solothurn, Switzerland to build a new production plant that will create about 400 new jobs beginning in 2019.
TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.
TxCell has suspended production at its plant in Besancon, France as it works to eliminate the risk cell therapies made there are contaminated by bacteria.
German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
Pall has licensed a ‘filterless filter’ technology which developers FloDesignSonic says bridges the gap between the up and downstream in continuous bioprocessing.
Green Cross Biotherapeutics has begun constructing a facility in Canada it says will produce up to five tons of injectable antibodies and 25,000kg of albumin annually.
Pluristem Therapeutics will set up manufacturing sites and find local partners to make cell therapies for the Chinese, Korean, Mexican, Russian and Israeli markets after securing various patents this week.
Biologics and focused R&D spending are driving the market for lyophilisation according to Symbiosis Pharmaceutical Services, which says its freeze-drying tech investment reflects this surge in demand.
Eli Lilly has hired CBRE Group to sell its biomanufacturing plant in Vacaville, California, which it claims is one of the largest bulk API manufacturing facilities for recombinant microbial-based biopharmaceuticals in the US.
The world’s top pharma and biologics manufacturing and processing companies have come together in New York this week to showcase the latest in equipment and services.
A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.
Sartorius has launched a cell harvesting technology, the first to incorporate diatomaceous earth filtration more commonly associated with the brewing industry.
CDMO Rentschler Biotechnologie has added GE's 1000th ÄKTAprocess, which is an automated liquid chromatography system built for process scale-up and large-scale biopharma, at its site in Laupheim, Germany.
Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.
Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.
Researchers have used shear stress to repair misfolded proteins in an approach that could help biopharmaceutical firms bypass expensive refolding techniques and time-consuming cell line optimization.
Manufacturing issues surrounding low protein content in batches of Sandoz’ Neupogen copycat have been resolved ahead of an FDA review which could herald the first US biosimilar.
Sartorius AG has announced plans to sell its industrial weighing and control tech business, Intec, as part of a long-term strategy to focus on bioprocessing and laboratory equipment.
Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.
Scientists at the Institute for Bioscience and Biotechnology Research (IBBR) are now recommending that biopharma manufacturers use nuclear magnetic resonance (NMR) testing to look for potentially harmful contamination by a group of plant enzymes called...
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
A hybrid of disposable and stainless steel systems will remain the biomanufacturing model for the near future, says Pall reporting a robust first quarter 2015.
Single-use continues to be adopted by the bioprocessing industry, but drugmakers are still hesitant to use disposable chromatography systems, says EMD Millipore.
