Author Archives: Dan Stanton

Zolgensma data: ‘Heavy-handiness’ of FDA a warning to industry, not just Novartis

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The US FDA may have made an example of Novartis in the way it handled the revelation of Zolgensma data manipulation, says the Alliance for Regenerative Medicine. A month after the US Food and Drug Administration (FDA) approved the one-time gene therapy Zolgensma (onasemnogene abeparvovec), marketing authorization holder Novartis alerted the agency to a data manipulation issue that impacted the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA). In its response,…

September 29, 2019

Peptide A? JSR teams on synthetic affinity chromatography ligands

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JSR Corporation has teamed with PeptiDream to develop a synthetic peptide-based affinity chromatography media that could be an alternative to costly Protein A resin. The partnership will combine PeptiDream’s drug discovery platform, PDPS (Peptide Discovery Platform System), with JSR’s knowledge of affinity separation technology to develop affinity chromatography media from unique peptides that bind to various target proteins in a specific manner. A peptide-based resin can be a platform for affinity purification for various types of therapeutic proteins, it could…

September 27, 2019

GSK opens $120m single-use drug substance plant in PA

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Equipped with disposable bioreactors up to 2,000 L, the plant in Upper Merion is ready to begin practice runs for GSK’s inducible T cell co-stimulatory (ICOS) receptor-agonist candidate. The site in Upper Merion, Pennsylvania has been a major source of manufacturing for GlaxoSmithKline (GSK) for over 20 years. With the opening of the $120 million (€110 million) ‘next-generation’ facility, the firm says it has created a “technologically-advanced manufacturing hub that offers the flexibility and speed necessary when making today’s complex…

September 27, 2019

Update: Thermo Fisher scaling single-use bioreactors up to 5,000 L

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There is increasing demand for large-scale single-use bioreactors says Thermo Fisher as it prepares to launch disposable systems up to 5,000 L in volume. Thermo Fisher Scientific showcased its latest bioprocess offerings at Biotech Week Boston earlier this month. This included an update to its HyPerforma DynaDrive single-use bioreactor (SUB) range, which will see the firm offer biomanufacturers disposable bioreactors with volumes more than doubling its current volume limit. Single-use technologies have been fully adopted by the industry, but most…

September 25, 2019

Biocon buys Pfizer R&D plant to bolster 28-strong biosimilar pipeline

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Biocon has acquired an R&D plant in Chennai from Pfizer healthcare India and plans to set up the 60,000 square-foot space to support its 28 molecule-strong biosimilar pipeline. Financial details of the acquisition have not been divulged, but a spokesperson from Indian drugmaker Biocon told this publication it has “acquired R&D capital assets from Pfizer healthcare India Ltd.†Specifically, this is a 60,000 square-foot facility at the TICEL Bio Park in Chennai, India, which will be established as a “bench…

September 25, 2019

Novavax poised to step up to Executive Order with recombinant flu vaccine

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President Trump has called for the modernization of influenza vaccine manufacturing. With its recombinant vaccine NanoFlu set to enter Phase III, Novavax says it offers the solution. Last week, the White House issued an ‘Executive Order [EO] on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health’ (reprinted below) aimed at addressing the “critical shortcomings†in the manufacture of such products. “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires…

September 25, 2019

Novo Nordisk: Danish and NC plants onside for oral GLP-1 launch

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The US Food and Drug Administration (FDA) has approved its first oral GLP-1 receptor protein: Novo Nordisk’s Rybelsus (semaglutide). Last week, Rybelsus became the first oral glucagon-like peptide (GLP-1) receptor protein treatment approved in the US as a non-insulin treatment for people with type 2 diabetes. The drug, marketed and made by Danish drugmaker Novo Nordisk, is used to increase the amount of insulin that the pancreas releases in response to food. The firm already has an approved subcutaneous semaglutide…

September 24, 2019

Biosimilars: Low cost + high approval rate = good return for Amgen

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Amgen says biosimilars represent an opportunity to get to market without the risk or cost of a novel biologic, so long as you have the capabilities. Within the biosimilar space, Amgen is curiously conflicted. It is one of the largest and most successful developers of such products, yet the firm is defending several of its novel blockbuster biologics from other biosimilar makers. In the US, where, Amgen has three approved products, launching two of them – Mvasi and Kanjiti, versions…

September 22, 2019

Sarepta looks to PD optimization to progress DMD gene therapy

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With Brammer and Paragon contracts, Sarepta Therapeutics has ample gene therapy manufacturing capacity but says it is now working on analytical and process development yield optimization. In 2018, Sarepta announced it was adopting a “hybrid manufacturing†approach to its gene therapy pipeline meaning it would build internal expertise in adeno-associated virus (AAV)-based manufacturing while partnering with contract manufacturers. As such, the firm entered into a long-term partnership with Brammer Bio – now part of Thermo Fisher – and Paragon Bioservices…

September 20, 2019

Pfizer adds $19m plant in NC clinical gene therapy shake-up

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Pfizer will relocate clinical manufacturing activities from its Chapel Hill site to a newly acquired facility nearby in the latest ramp up of its North Carolina gene therapy capabilities. This week, big biopharma firm Pfizer acquired a piece of land and newly constructed building at 1219 Shiloh Glenn Drive, North Carolina – about 2 miles west of Raleigh-Durham International airport – set to become a center of clinical manufacturing for its gene therapy programs. Pfizer confirmed the news first broken…

September 20, 2019