Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.
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.
A technology developed to reduce time and increase safety when reconstituting lyophilised biologics has been put for up for sale after XstalBio's insolvency.
Repligen has launched a single-use version of its XCell ATF cell retention system which can reduce implementation costs by as much as 55% compared to its stainless steel equivalent.
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%.
GE Healthcare has opened a $7.4m bioprocessing technology and training centre on the back of South Korea’s commitment to the biosimilar and biomanufacturing industries.
European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.
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.
Custom-made affinity resins can offer biomanufacturers flexibility and shorten development timelines says Avitide, fresh from securing Series D financing from Mithril Capital Management.
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.
Ambition, hard work and a focus on quality has made Celltrion the ‘pioneers of the mAb biosimilar industry,’ the firm told Biopharma-Reporter during a tour of its biomanufacturing site in Songdo, Korea.
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.
Vendors have again reported high growth in sales of single-use systems and according to Eric Langer from BioPlan Associates this trend is set to continue.
Merck confirms plan to close sites in US, Brazil and Japan
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
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.
Investing in facilities that allow customers to test biomanufacturing equipment and processes is both cost-effective and necessary due to Biopharma's regulatory demands, say Merck, Pall and GE.
Increased biologics both on the market and in development and demand for greater manufacturing efficiencies have led to another strong quarter for Thermo Fisher.
Interested in moving from small to large molecule manufacturing? An upcoming course will address mAb characterisation challenges and offer hands-on experience for small molecule manufacturers , says NIBRT, Ireland’s biomanufacturing training centre.
Adaptimmune has entered into a new 10-year development and supply agreement for use of thermos Fisher’s Dynabeads CD3/CD28 CTS T-cell isolation, activation and expansion technology.
Differentiated technologies buoyed by the recent $600m conjugation deal with Roche is driving Catalent’s biologics business, the firm told Biopharma-Reporter at BIO.
A downstream centre in Scotland will allow local biotechs to test product scale-up without outsourcing overseas, while complementing other Government-funded bioprocessing projects in the UK.