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.
Repligen has bought Novasep subsidiary TangenX Technology for $39m, adding single-use tangential flow filtration (TFF) cassettes to its downstream offering.
bluebird bio Inc has hired apceth Biopharma GmbH to make its candidate ALD cell therapy Lenti-D and its thalassemia treatment LentiGlobin for the European market.
Bristol-Myers Squibb has announced plans to pull the plug on some US facilities and streamline construction and investment around “vibrant academic ecosystems”.
Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.
Sanofi, Merck & Co. and downstream technology firm Natrix have teamed to develop a chromatography system with a productivity level capable to enable a fully-integrated downstream platform.
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.
Sinovac’s vaccine sales recovered in Q3 after it restarted activities halted while it brought operations into line with new Chinese distribution regulations.
While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.
A technology developed to reduce time and increase safety when reconstituting lyophilised biologics has been put for up for sale after XstalBio's insolvency.
Shire says it is closing a plasma fractionating facility in Los Angeles, US but remains positive it can successfully manage its post-Baxalta manufacturing network of 17 sites.
The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
Danaher Corporation will further extend its presence in the life sciences space through the acquisition of separations and purification firm Phenomenex.
The conservatism of the biotech industry held back adoption of continuous manufacturing tech but this is now changing says Novasep, winner of the CPhI bioprocessing award.
Sartorius Stedim Biotech (SSB) claims benchtop vaccine and protein purification techs could save developers €2000 per batch and reduce processing time by 60%.
The cell and gene therapy plant Lonza is building in Pearland, Texas will be bigger than originally planned to according to the city’s economic development corporation.
Innova Biosciences says its AbPure Protein A-based system removes the need to undergo an additional step when purifying antibody in preparation for conjugation
MilliporeSigma plans to use gene editing to help developers make cell lines resistant to viruses that cost manufacturers millions in contaminated products.
Jacobs Engineering Group has been contracted to collaborate with GE Healthcare on the development of Pfizer’s $350m monoclonal antibody manufacturing centre in Hangzhou, China.
Custom-made affinity resins can offer biomanufacturers flexibility and shorten development timelines says Avitide, fresh from securing Series D financing from Mithril Capital Management.
SGS has opened a new Wiesbaden-based facility to serve as its global Center of Excellence for Extractable Studies and Impurities Profiling as customer demand increases.
Welsh chromatography resin maker Purolite says it aims to capture 30% of the Protein A market through its 100,000L facility on track to open next year.
Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.
Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.
Novartis has recruited Jacobs to undertake a €100m expansion at a French biomanufacturing facility which will add a second purification line and several cell culture bioreactors.
Continuous manufacturing can reduce costs and is already being pursued by CMOs looking to increase productivity by up to 30%, says fluid processing tech firm LEWA.
