Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.
EpimAb Biotherapeutics will combine its bispecific antibody generating technology with Kymab’s mouse mAb production platform in a cross-licensing deal between the two firms.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
GE Healthcare is in discussions with companies looking to buy four fully-equipped ‘off-the-shelf’ facilities as part of a €150m investment into a biomanufacturing campus in Ireland.
Since 2011, Samsung Biologics has built two plants, gained Bristol-Myers Squibb and Roche as clients and launched an IPO. With a third facility under construction, Biopharma-Reporter visited to see the CMO’s ambition in action.
Mammalian cell line developer Selexis has signed a fourth licensing agreement in as many months and is planning a "major expansion" early next year ahead of anticipated demand.
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.
The International Society for Cellular Therapy (ISCT) has called for a streamlined manufacturing regulatory pathway for cellular therapies to overcome the high upfront costs of manufacturing such products.
Phages, peptides and live biotherapeutics could help combat antibiotic-resistant bacteria but don’t expect heavy R&D investment until people start dying from post-operative infection, says EpiBiome.
High US approval rates of monoclonal antibodies is driving demand for Protein A, and with the arrival of biosimilars this is unlikely to slow down, says Repligen.
Pfizer pays $150m for Bamboo Therapeutics, and post-merger Shire terminates a Baxalta haemophilia programme. Welcome to Biopharma-Reporter’s gene therapy focus.
Charles River says it is capitalising on the growing number of biologics in development, with its manufacturing business seeing double-digit growth led by demand for biosafety and cell banking services.
Abzena will make Faron's drug candidate Clevegen - an antibody that neutralises a subset of immune cells linked to tumor proliferation - at a recently acquired single-use facility in California.
The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.
Anglo-American life science firm AMS Biotechnology has launched new cell lines to help companies researching the PD-1/PD-L1 pathway, one of the hottest areas of immuno-oncology research.
Porton Biopharma has begun construction on a new bioprocess development and manufacturing facility in the UK equipped with fermentation and down-stream processing suites.
Kite Pharma has opened a T-cell manufacturing facility in California it says can overcome the logistical problems of autologous therapies and treat up to 5,000 patients per year.
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.
An expansion in Ireland for Eurofins, new cell screening tech for Cyprotex, and an mRNA development deal for Charles River. Welcome to Biopharma-Reporter’s bio-service round-up.
Single-use technology is driving a new era in vaccine development says PnuVax which has acquired IP from GE Healthcare to produce an inactivated yellow fever vaccine.
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.
Industry’s uptake of stainless steel systems continues to fall as biomanufacturers move away from large volume blockbuster biologics, according to GE Healthcare.
Combination therapies and collaboration will be key in curing cancer, according to Pfizer which has seen 'astounding progress' in its immuno-oncology partnership with Merck KGaA.
BioLife Solutions has partnered with transportation firm MNX and says it expects increased demand for its biologistics services as more cell therapies enter the clinic.
Daiichi Sankyo has paid Cell Therapy Ltd £12.5m ($18m) for the Japanese rights to its cardiac regeneration candidate Heartcel, made from allogeneic stem cells.
Distance and time differences are not barriers when choosing a biologics CMO, says Goodwin Biotechnology which has won a bispecific antibody process and scale-up contract from Russia’s IBC Generium.
Three deals in the last week signal AbbVie’s strategy in immuno-oncology but are just the latest examples of Big Biopharma’s trend for clinical partnerships.
Eppendorf will tackle the challenges of scaling-up human induced pluripotent stem cells (hiPSCs) as part of a Horizon 2020 project to develop cell-based heart therapies.
Cell therapy firms must invest in engineering and learn from biopharma according to the US Government, which says high cost of regenerative treatments is slowing uptake.
Bristol-Myers Squibb has announced plans to set up a biomanufacturing process laboratory in collaboration with Ireland's National Institute of Bioprocessing Research and Training (NIBRT).
The partnership with recombinant protein development firm GTP Technologies will create an end-to-end manufacturing service, speeding up production of monoclonal antibodies and reducing costs, says Novasep.
The changeover time between batches is significantly quicker using disposable equipment, says Avid Bioservices whose new biomanufacturing facility boasts several 1,000L single-use bioreactors.