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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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by BPI Staff

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

by Dan Stanton

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…

High Octane: Lonza buys 80% of ‘game-changing’ cell therapy tech partner

by Dan Stanton

Lonza has acquired a controlling stake in its partner Octane Biotech and will incorporate the closed and automated Cocoon processing tech into its autologous cell therapy offering. Contract development and manufacturing organization (CDMO) Lonza has collaborated with Octane Biotech for the past three years to develop the Cocoon manufacturing system. But this week, the Swiss CDMO purchased additional equity to hold a controlling stake of 80% in the firm, with an option for outright ownership. “Owning a controlling stake ensures…

Samsung Bioepis riding the biosimilar third wave

by Dan Stanton

Samsung Bioepis has beefed up its biosimilar pipeline with versions of Lucentis (ranbizumab) and Soliris (eculizumab) under development. In Europe, South Korean biopharma firm has achieved commercial success with four biosimilar products. In the US – through commercialization partner Merck & Co. – it has launched one and has two other biosimilars under review. When looking at the market and large pharma biosimilar makers such as Pfizer and Sandoz “we are up to par with the ‘big boys’ in terms…

Turning of the tide: High potential for oligos, says survey

by Dan Stanton

Within the tides space, oligonucleotides hold the most opportunity for commercial success and growth say respondents of a KNect365 survey. The oligonucleotide therapeutic market could be viewed as having suffered a false start. The potential of antisense oligonucleotides to silence specific genes was jumped upon in the 1980s with numerous companies investing heavily in the field and commencing hundreds of clinical trials. However, the unexpected complexity of oligonucleotide pharmacology somewhat dampened the sector. And though the US Food and Drug…

Janssen closing in on ‘holy grail’ through $82m HIV vaccine plant

by Dan Stanton

Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate. Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million). The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of…