GE Healthcare says a new inflatable bioreactor bag configured in perfusion mode can achieve a cell density over four times that of the current industry standard.
Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.
Donald Trump’s withdrawal from the Trans-Pacific Partnership (TPP) could end up benefitting Asian biosimilar makers and reducing US jobs, says an IP lawyer.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.
Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014.
ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
With increased interest in cell and gene therapies, BioLife Solutons has reported a 28% year-on-year growth in sales of biopreservation media, while Cryoport has struck another logistics deal.
Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.
A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
A UK judge says a vexatious litigation strategy is staving off Humira biosimilars, but AbbVie is “playing by the rules and incurring the costs of doing so,” according to an IP lawyer.
The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
The majority of biomanufacturers use single-use systems at least in the development stage says Entegris’ Eric Isberg, but scaling-up will always be a challenge.
Takeda has inked a 5-year deal to finance development of T-cell therapy redirection platform from recently founded biotech, Maverick Therapeutics, with exclusive right to buy.
US FDA sticks with four-letter random suffix for biosimilar names
Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.
President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.
Teva aiming to be major second and third wave biosimilars company
Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.
CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development.
Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.
Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.
Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.
PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.
Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.
Crown Bioscience will invest $1m into a new subsidiary in Louisiana state to work alongside a new research facility at the New Iberia Research Center (NIRC).
GE Healthcare hopes to increase the yield of biopharmaceuticals made using its Chinese Hamster Ovary (CHO) expression system through a partnership with synthetic biology firm Synpromics.
