Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.
Contractor Trenzyme GmbH has licensed a CHO cell line-based expression system from Swiss firm Celonic AG in a deal designed to expand its service offering.
Biologic drugs will be given a minimum of five years of data protection under the TPP (Trans-Pacific Partnership) trade deal agreed today, upsetting industry groups which had campaigned for 12.
Lonza has published a guide to clinical-grade induced pluripotent stem cell (IPSC) manufacture, addressing concerns around the derivation of cellular materials.
Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.
Regeneron Pharmaceuticals will use it speedy mAb development tech to move an Ebola drug into clinical trials under a $38m (€34m) US Government contract.
Sandoz has reiterated its call for US FDA guidance on biosimilar interchangeability arguing that the lack of clarity makes it hard to gauge what impact switching rules will have on pricing.
Influenza research completed just before the US banned ‘gain-of-function’ studies could help vaccine makers boost virus yields and accelerate production say scientists.
Boehringer Ingelheim has licensed a microbial expression technology from Vectron Biosolutions for use with its own molecules and for customers through its CMO business.
Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.
Army training is ideal preparation for a biopharma career according to the US National Center for Therapeutics Manufacturing, which is seeking former military personnel interested in learning about bioprocessing.
A surge in UK cell therapy production last year means available manufacturing capacity has declined considerably according to a report by Cell Therapy Catapult.
Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.
The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
Mass produced regenerative therapies are a step closer say UK researchers who have developed a polymer substrate they claim can be used to set up “stem cell factories.”
Stem Cell Theranostics has secured rights to the technology it uses to make cellular heart disease models for drug development through a deal with GE Healthcare.
Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.
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.
As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...
TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.
GSK and UK academics claim a newly identified enzyme is the missing link in the mechanism poppies use to make painkilling alkaloids like morphine and codeine and the anticancer compound noscapine.
Scientists have developed a new way of visualizing multiple myelomas in 3D by replicating tumours in hens’ eggs in a approach they say will aid drugmakers.
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.
Aragen Bioscience and Transposagen Biopharmaceuticals have launched a knockout CHO cell line and development services they clam allows for the development of more effective therapeutic mAbs.
Rumoured Big Pharma takeover target GSK has invested $95m to set up an cell genetics research institute to help developers better identify drug candidates.
Correctly identifying cell lines used in cancer drug development would cut the amount US researchers spend on preclinical research that cannot be reproduced.
California-based Allele has bought a facility to manufacture human induced pluripotent stem cells (hiPSCs) using its “footprint-free” synthetic mRNA technology.
Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.