Author Archives: BPI Staff

Meissner expanding footprint with Irish gov support

Filtration firm Meissner will establish a facility in County Mayo, Ireland for the manufacture of single-use systems, creating 150 jobs. Meissner Filtration Products has taken advantage of a 34,000 square-foot facility Advanced Technology Building, constructed by Ireland’s investment agency IDA, and plans to expand it by a further 100,000 square-feet. The firm plans to construct a cleanroom within the existing facility to be used for the manufacture of single-use systems (SUS) to support biopharmaceutical clients. Adjacent land at the site…

VBAs and marketing campaign to aid RNAi Onpattro ramp up, says Alnylam

Around 200 patients have so far been treated with Onpattro (patisiran), the first approved RNA interference (RNAi) drug, bringing in $12.5 million for Alnylam. In August 2018, the US Food and Drug Administration (FDA) and the European Commission (EC) approved Alnylam Pharmaceuticals’ Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The approvals heralded in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. Onpattro works by silencing a portion of RNA involved…

Janssen enters $440m retinal gene therapy partnership

J&J has licensed a clinical stage inherited retinal disease portfolio from MeiraGTx in a deal that could be worth $440 million (€385 million). Johnson & Johnson’s Janssen division has paid $100 million upfront to MeiraGTx, a London-UK based clinical stage company, to access and codevelop the firm’s gene therapy programs. Development and sales milestones for MeiraGTx’s could net the firm a further $340 million. Under terms of the deal, the two firms aim to develop, manufacture and commercialize several candidates…

Samsung BioLogics to double utilization of 3rd plant by end of year

Three months after production began at its 180,000 L facility, CDMO Samsung BioLogics says it has filled 25% of its capacity. In October 2018, South Korean contract development and manufacturing organization (CDMO) Samsung BioLogics started commercial production at its third facility located at its Songdo, Incheon site. The plant has been touted as the world’s largest single biomanufacturing facility, boasting 180,000 L of capacity from 12 15,000 L stainless steel tanks, and according to Samsung BioLogics’ 2018 results, it is…

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…

Boehringer expanding China CDMO plant

Boehringer Ingelheim has begun an expansion at its biomanufacturing facility in Shanghai as it looks to tap the “great potential in China.” The expansion at the site in Shanghai covers an additional bioreactor and will include the necessary utility and infrastructure to support GMP operations of two 2,000 L single use bioreactor manufacturing lines. When asked, the Germany-headquartered firm did not divulge further details on the specifics of the investment. Boehringer Ingelheim spent more than €70 million in the first-phase…

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…

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.…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…