Portola Pharmaceuticals Inc has hired Lonza to make AndexXa (andexanet alfa), the candidate anticoagulation antidote it resubmitted for US FDA review last month.
3SBio will leverage Therapure’s downstream purification expertise to bolster its own biologics portfolio while expanding its contract biomanufacturing business and global presence.
After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.
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.
Filtration drove a record quarter for Repligen which says the addition of Spectrum Pharmaceuticals will further grow its bioprocessing portfolio and geographical presence.
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.
Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.
Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.
German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission
French technology firm Cellnovo has selected Flex Ltd to build a production line in Romania, to manufacture insulin cartridges for its diabetes management system.
Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.
ChromaTan will incorporate Purolite’s Protein A beads into its continuous platform in a move the firms say will up productivity by 15 times over conventional batch chromatography.
LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.
Its new Singapore single-use plant is a fraction of the size of a conventional commercial facility but next-generation biomanufacturing at Amgen points to even smaller, more integrated sites.
Integrating single-use, automation and continuous processing equipment will be the future for bioproduction says Thermo Fisher acquisition Finesse Solution.
Pall Corporation, GE Healthcare and LEWA Process Technologies showed off their latest downstream offerings to Biopharma-Reporter in Amsterdam last week.
Danaher reported mid-single-digit growth from its bioprocessing subsidiary Pall Life Science and expects a continued trajectory to support Biopharma’s filtration needs.
MilliporeSigma has launched a range of high area cartridges and single use capsules it says gives biomanufacturers greater efficiency in the filtration step.
GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.
There is a growing trend among vendors to integrate automation technologies into their offerings says a bioprocessing expert, as GE Healthcare invests in its partner Zenith.
Sumitomo Dainippon Pharma Co Ltd has ordered cell culture technologies from Hitachi as part of its effort to develop a treatment for Parkinson’s disease.
Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.
Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.
Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.
GE Healthcare has completed another tech installation at FujiFilm Diosynth’s biopharmaceuticals facility in Billingham, UK, integrating a single-use purification system with bioreactors it provided in 2014.
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
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.
CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development.
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.
