Therapeutic Class

Continuous gene therapy production targeted in UK collaboration

Cobra Biologics and the Cell and Gene Therapy (CGT) Catapult have teamed with Pall to explore continuous manufacturing of gene therapies. The project builds on a concurrent collaboration which looks to reduce the cost of adeno-associated virus (AAV) vectors. The collaboration received a £1.5 million ($1.9 million) shared grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications. “The project is a joint collaboration between Cobra, Pall and the…

Founding member Amgen turns back on Biosimilars Forum

Amgen withdrew its membership from advocacy group The Biosimilars Forum in September after disagreeing on how best to support the US biosimilar market. Nonprofit organization The Biosimilars Forum was setup in 2015 “to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care… [by providing] evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars,” according to its mission statement. The founding 11…

Celgene investing in ‘vein to vein supply chain’ to support CAR-T biz

Fresh from acquiring CAR-T firm Juno Therapeutics, Celgene is investing in patient treatment centers and building out its manufacturing capacity. In March, Celgene Corporation completed the $9 billion (€7.9 billion) acquisition of Juno Therapeutics, adding chimeric antigen receptor (CAR) T-cell technology and manufacturing capabilities, along with a pipeline of hematology and oncology therapies. Speaking at the Credit Suisse 27th Annual Healthcare Conference last week, CFO David Elkins said its numerous CAR-T collaborations – the firm has a co-development deal with…

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…

NIIMBL and BPOG publish roadmaps for ADCs, vaccines and gene therapies

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), in collaboration with the BioPhorum Operations Group (BPOG), has published a series of technology roadmaps for the biopharma industry. The roadmaps cover manufacturing issues surrounding gene therapies, vaccines, antibody-drug conjugates (ADCs) and bi-specific antibodies, and are based on insight from biomanufacturers, equipment makers, suppliers, academic institutions, non-profits, and federal agencies. They are intended to provide a clear vision of innovation for biopharmaceutical manufacturing processes and platforms and address technology needs and…

BioLife eyes up M&A in ‘fragmented’ regenerative med supply space

The cell and gene therapy tool supplier space is ripe for consolidation says BioLife Solutions, which is evaluating several acquisition targets. For the third quarter 2018, regenerative medicine consumables and tools firm BioLife reported sales of its biopreservation media product of $5.3 million (€4.7 million), up 79% year-on-year. With the firm also turning a profit of $1.2 million for the period, CEO Michael Rice spoke about the scaling-up opportunities to take advantage of the continued demand from the cell and…

Bye bye biosimilars: Big Pharma’s imminent exit in sight, says expert

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term. Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate…

Astellas invests $256m in Japanese and US antibody and cell therapy sites

Astellas says it is responding to the supply needs of future pipeline by constructing two multi-modality Japanese sites and relocating a regenerative medicine plant in Massachusetts. Both R&D and manufacturing are being looked at through the expansion of sites in Toyama and Tsukuba, Japan, and Massachusetts, US to progress the development and commercialization of Astellas’ portfolio. “Astellas is responding to the progress being made in the development and launch of new drugs from its existing portfolio and pipeline,” a spokesperson…

GSK selects Hitachi to make T-cell therapy

Hitachi Chemical Advanced Therapeutics Solutions (HCATS) will make clinical batches of GlaxoSmithKline’s T-cell receptor therapy targeting NY-ESO-1 from its New Jersey site. The three-year agreement will see HCATS manufacture clinical batches of GSK’s T-cell receptor therapy targeting New York esophageal squamous cell carcinoma 1 (NY-ESO-1). The SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell therapy is one of a number of cancer immunotherapies being codeveloped between GSK and Oxford, UK-based Adaptimmune, in a collaboration inked in 2014. The clinical production of…

GSK to ramp-up Shingrix vaccine as demand outstrips supply

GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity. In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its…