Author Archives: Dan Stanton

Manufacturing shift to Ireland frees up US capacity for Regeneron’s COVID antibodies

Regeneron is shifting production of non-COVID therapies from its US facilities to its site in Limerick, Ireland to make space for a potential antibody cocktail against COVID-19. Regeneron’s efforts to combat COVID-19, caused by the novel coronavirus (SARS-CoV-2), is a monoclonal antibody (mAb) cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein. The prospective therapy, REGN-COV2, developed using technology and experience demonstrated by the firm’s investigational triple antibody cocktail treatment for Ebola REGN-EB3, is is in…

ADC approval flurry a driver in MilliporeSigma $65m WI expansion

With five US FDA approvals over the past 15 months, MilliporeSigma says it is confident that antibody-drug conjugates (ADCs) will continue to be a driver of new therapeutics for years to come. A $65 million expansion in Wisconsin aims to exploit this. The Madison, Wisconsin expansion will bring MilliporeSigma’s contract manufacturing wing large-scale manufacturing capacity for high-potent active pharmaceutical ingredients (HPAPIs). The 70,000 square-foot facility will be designed to handle single-digit nanogram occupational exposure limit materials and will incorporate containment…

As COVID disrupts FDA inspections, will liso-cel approval be further delayed?

Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…

Automation: ‘The only way to truly scale cell therapy manufacture’ says Lonza

Lonza says it has achieved a significant milestone with partner Sheba Medical treating its first patient with a CD19 CAR-T cell immunotherapy made using the automated point-of-care Cocoon technology. In March 2019, Swiss CDMO Lonza entered a partnership with Israel’s Sheba Medical Center to provide automated and closed CAR-T manufacturing using its point-of-care (POC) Cocoon cell therapy manufacturing platform. This week, Sheba and Lonza announced the first patient has been dosed with a CD19 CAR-T cell immunotherapy made using the…

Thermo-stability could give DNA vaccine advantage in COVID-19 race, says Inovio

Inovio says the long shelf life and tolerance to heat of its DNA vaccine candidate could set it apart from the mRNA, protein, and viral-based COVID-19 vaccines in development. Inovio’s COVID-19 vaccine INO-4800 is composed of synthetic, circular DNA plasmids that encode parts of the viral protein. The candidate is in Phase I trials but Inovio is looking to initiate Phase 2/3 studies later this month, subject to US Food and Drug Administration (FDA) clearance. The candidate lags behind other candidates…

Bridgewest gains CDMO biz through Pfizer pegfilgrastim plant buy

Bridgewest Group will manufacture products for previous owner Pfizer among others after acquiring a microbial manufacturing plant in Adelaide, Australia. Bridgewest Group has made numerous investments in life sciences companies, but the acquisition of the Pfizer facility in Adelaide by subsidiary Bridgewest Australia Holdings marks the first expansion into the contract biologics space. Previous investments include antibody developer BioAtla and third-party pharma services firm BioDuro. According to Ian Wisenberg, CEO of Bridgewest Australia Biotech, the biologics contract development and manufacturing…

Adios AveXis: Novartis embeds $8.7bn acquisition into gene therapy rebrand

Gene therapy developer AveXis will be known as Novartis Gene Therapies, more than two years after being acquired by the Swiss biopharma giant. In May 2018, Novartis spent $8.7 billion to acquire gene therapy technology and therapy developer AveXis. Since then, Novartis has supported the commercialization of its spinal muscular atrophy (SMA) single-dose therapy Zolgensma (onasemnogene abeparvovec), while investing heavily into the bolt-ons manufacturing capabilities. In February, AveXis/Novartis opened a $115 million gene therapy production plant in Durham, North Carolina.…

MilliporeSigma adding 160 jobs to expanded NH filtration plant

MilliporeSigma will run a recently expanded facility in Jaffray, New Hampshire on a 24-hour cycle due to increased demand for filtration devices and membranes, driven in part by COVID-19. In June 2019, MilliporeSigma – the bioprocessing business unit of Germany’s Merck KGaA – announced plans to expand its site in Jaffrey, New Hampshire. The site produces a variety of filtration devices and membranes that support the life science industries and the manufacture of biopharmaceuticals. The 35,800 additional square feet of…

Proteinea using fly larvae as ‘mini-bioreactors’ in challenge to industry

Producing recombinant proteins in fly larvae instead of single-cell technologies could reduce biomanufacturing costs by up to 90%, says bioprocess startup firm Proteinea. Proteinea, a US and Egyptian startup, is looking to change the economics of biomanufacturing. The firm challenging the standard of using stainless-steel or single-use bioreactor systems to produce biologics by instead leveraging its insect-based biotechnology platform. Rather than produce a recombinant protein in single bacteria, yeast or mammalian cells, the firm uses InsectaPro, its platform comprising of…

Astrea buys filtration firm ELS and hints at more acquisitions

Astrea Bioseparations has acquired Essential Life Solutions (ELS) adding a chromatography column portfolio and operations in the US. The deal, financial details of which have not been divulged, closed last week bringing Astrea the SNAP brand of chromatography column products for research and small-scale purification of biological products. “SNAP columns are high precision, glass columns used with HPLC/FPLC systems for development of purification processes and lab scale chromatography,” Astrea told this publication. The range will complement Astrea’s bioprocess offering, which…