Author Archives: BPI Staff

BioProcess International West: Event Planner

BioProcess International US West is the leading phase-based bioprocessing event for accelerating promising biologics toward commercial success. Whereas most bioprocessing event sessions are broken out by departmental function — e.g., analytical, upstream, and downstream — the BPI US West sessions are defined by stage of development, providing drug developers a unique opportunity to break down silos across multiple departments to discuss today’s leading solutions toward improving the speed, lowering the cost, and increasing the quality/safety of biologics in development. Each…

Adaptimmune on the merits of inhouse T-cell production

Adaptimmune says the only way an autologous T-Cell firm can control the evolution of production technologies is to have the process under its own roof. Adaptimmune Therapeutics began working with contract development and manufacturing organization (CDMO) PCT – now known as Hitachi Chemical Advanced Therapeutics Solutions (HCATS) – in 2013 and entered into a five-year strategic partnership in 2016 for the manufacture of its autologous SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell cancer immunotherapies. But the firm has also been…

Novartis licenses Factor XI Ab to Blackstone-backed $250m bio firm

Newly launched firm Anthos Therapeutics has licensed Novartis candidate MAA868 and will look to develop it for cardiovascular disorders. Novartis retains a minority stake in the Blackstone-backed biopharma. Private investment firm Blackstone Life Sciences launched this week Anthos Therapeutics, a biopharma company focused on advancing next-generation targeted therapies for high-risk cardiovascular patients. The company, backed by $250 million (€220 million) of Blackstone funds, will look to a Novartis candidate as a potential anti-thrombotic therapy to treat patients currently underserved by…

Merck accessing cancer vaccine tech through $300m acquisition

Merck & Co. will acquire Immune Design for $300 million, adding cancer immunization and adjuvant systems technologies to its portfolio. The deal, expected to close early in the second quarter of 2019, sees Merck & Co. (known as MSD outside of North America) acquire late-stage Californian immunotherapy firm Immune Design for $5.85 (€5.15) per share in cash, totaling around $300 million. “Our primary interest to acquire Immune Design is related to their unique portfolio of approaches to cancer immunization and…

FDA guidelines aim to improve quality and lower costs

The US FDA has issued draft guidance intended to promote innovation in pharmaceutical development and manufacturing. Entitled ‘Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry,’ the draft guidance has been produced by the US Food and Drug Administration (FDA) to informally recognize voluntary consensus standards relating to pharmaceutical quality for products under the jurisdiction of the Center for Drug Evaluation and Research (CDER). “The overall goal of this program is to promote development…

‘Impressive roster of participants’ brings $42m to PureTech affiliate

Vor Biopharma, founded by PureTech, has raised $42 million to support its hematopoietic stem cell (HSC)-based candidate through Series A financing round. Vor Biopharma, co-founded by biopharma firm PureTech, will use the $42 million (€37 million) to advance its lead HSC-based preclinical candidate for the treatment of acute myeloid leukemia (AML) and to further build its pipeline to treat hematologic malignancies. According to Jefferies equity analyst Peter Welford, the Series A financing round included an “impressive roster of participants,’ led…

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…