Upstream & Downstream Processing

Amgen completes five-year plan, sees 24% drop in facility footprint

Amgen’s commitment to next generation biomanufacturing has led to a reduction in its facility footprint of nearly a quarter since 2013. In 2013, Amgen commenced a “company-wide re-engineering process” aimed at transforming its business to prepare for long-term growth. The restructure included significant job cuts and plans to reduce facility footprint by 23%, while ensuring increased bulk production through next-generation biomanufacturing platforms. Five years on, and David Meline, Amgen’s CFO, said the firm has successfully transformed “the business “to achieve…

Merck and MIT look to continuous cell-based vaccines in NIIMBL project

An 18-month project partners Merck & Co. with vendor Repligen and academia to develop approaches for continuous cell-culture based vaccine manufacturing. The program, entitled ‘The Continuous Cell Culture for Viral Vaccines’ is being led by the Massachusetts Institute of Technology (MIT), will bring together Big Biopharma firm Merck & Co. (known as MSD outside North America), bioprocessing vendor Repligen, Massachusetts Life Sciences Center, and the University of Massachusetts Medical School. It is one of 22 projects recently announced by the…

Gamma Delta T GMP: TC Biopharm creates allogeneic cell banks

TC Biopharm has formulated its first Gamma Delta T (GDT) cell banks it says provides the firm with the technology to develop next-generation allogeneic CAR-T therapies. Supported by a €4 million ($4.5 million) grant from the European Union’s Horizon 2020, Scotland, UK-based biotech TC Biopharm has completed formulation of its first GDT cell banks intended to help rapidly progress its allogeneic therapies through the clinic. “GDT cells are a subset of white blood cells and are part of the innate…

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

This is the first time in history that we can make more effective medicines than we can afford, says Dark Horse Consulting. The Phacilitate conference took place in Miami this week, and in the plenary session Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, described the latest developments in the field of regenerative medicine. With the approvals of Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) in 2017, “this field finally had the year…

Bavarian Nordic to validate fill/finish plant using $44m US gov option

The US Biomedical Advanced Research and Development Authority (BARDA) has exercised a second option in its smallpox vaccine contract with Bavarian Nordic. In September 2017, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million). To support the agreement, BARDA exercised an option in 2017 to cover development costs associated with the Phase III study of the…

Solentim and ATUM team partner for cell line development service

The collaboration brings together instrumentation with expression technology to create what the firms say is “the most efficient cell line development solution for biotherapeutic drug developers yet.” The collaboration – financials of which have not been divulged – aims at overcoming the bottlenecks in biomanufacturing by establishing and isolating the most suitable cell lines for a drug candidate. The combined offering will appeal to “pharmaceutical and biopharma companies wanting to shorten their cell line development timelines and make sure they…

Sanofi turns to high titer E. Coli platform in AbSci deal

The SoluPro E.coli manufacturing platform will be applied to two of Sanofi’s biologic candidates under a partnership deal with AbSci. Financial details of the deal have not been divulged, but the French Big Biopharma firm will use AbSci’s SoluPro expression platform on two of its molecules. The work will be undertaken at AbSci’s facilities in Vancouver, Washington, USA. According to AbSci, the platform can accelerate the time it takes to get new drugs to market through ultra-high titers of soluble,…

Selexis and Agenus expand immune-oncology cell line deal

After an initial collaboration in 2015, Selexis has signed commercial license agreements with Agenus to develop research cell banks for additional antibody programs. In 2015, clinical-stage immuno-oncology firm Agenus selected cell line development firm Selexis to collaborate on its lead anti-CTLA4 (AGEN1884) and anti-PD1 (AGEN2034) programs. Four years on and the firms have extended the deal to include the use of Selexis’ SUREtechnology platform with additional novel single agent and combination therapies. “Under the expanded collaboration, Selexis will continue to…

Univercells to scale-up sub 30 cent polio vaccine platform

A Univercells-led consortium has received a grant extension to scale-up a manufacturing platform it claims can slash the cost of inactivated polio vaccines. In December 2016, a consortium led by Belgium biomanufacturing technology firm Univercells received a $12 million (€10.4 million) grant from the Bill & Melinda Gates Foundation to develop a low-cost vaccine manufacturing platform. The consortium also involves Batavia Biosciences which has developed the polio manufacturing process and Natrix Separations (now owned by MilliporeSigma) for the purification membrane.…

Up titer: WuXi breaks 50g/L with continuous CHO process

WuXi Biologics has achieved cell culture productivity for an Fc-fusion protein of 51 g/L and is confident it can be scaled up to 4,000 L. Single-use bioreactors are limited to 4,000 L in capacity (though many biomanufacturers put 2,000 L as their upper limit). Using these bioreactors with mammalian cell line tech is problematic for large-scale commercial use due to the generally low productivity of such expression systems, usually sub-10 g/L. But Chinese contract development and manufacturing organization (CDMO) WuXi…