Author Archives: Dan Stanton

Catalent pumping $200m into biomanufacturing expansions

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Catalent plans to double fill/finish capacity at its Bloomington site and add a fourth and fifth train at its Madison drug substance facility. During its fourth quarter FY2018 call, contract development and manufacturing organization (CDMO) Catalent said it was eyeing up a fourth and fifth biomanufacturing train at its Madison, Wisconsin plant. And during its Q1 FY2019 investor call, CEO John Chiminski confirmed the board has approved both the expansion in Madison and a doubling of capacity at its Bloomington,…

November 7, 2018

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

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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…

November 7, 2018

Singapore swing: Lonza transfers Tracon Ab to single-use plant

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CDMO Lonza has produced the first 2,000 L batch of Tracon Pharmaceuticals’ antibody TRC105 from its Singapore facility after transferring production from the UK. Californian biopharma firm Tracon has been using Swiss contract development and manufacturing organization (CDMO) Lonza for the manufacture of its lead candidate TRC105 (carotuximab) since the pre-clinical phase of development. The candidate is an antibody to endoglin – a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel…

November 6, 2018

Novartis pulls US rituximab program citing FDA data demands

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Novartis subsidiary Sandoz has decided not to pursue a biosimilar of Roche’s Rituxan in the US after receiving a complete response letter from the FDA. In June 2017, biosimilar developer Sandoz received approval in Europe for Rixathon, a version of Rituxan (rituximab), which Roche markets as Mabthera in the region. But across the Atlantic, the Swiss biopharma has failed to replicate such regulatory success, and received a US Food and Drug Administration (FDA) complete response letter (CRL) in June this…

November 5, 2018

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

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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…

November 5, 2018

GSK to ramp-up Shingrix vaccine as demand outstrips supply

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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…

November 2, 2018

Q3 saw $1.5bn in biotech IPOs, and no slowdown in sight

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The biotech sector saw the largest capital investment over the past quarter and life sciences’ momentum has far from peaked, says accounting firm CohnReznick. In the past financial quarter, life sciences and biotech initial public offerings (IPOs) pulled in $1.5 billion (€1.3 billion) in capital investment. According to national professional services and accounting firm CohnReznick, the sector was the number one industry for IPOs, with 20 deals taking place in the quarter, representing 30-35% of all deals. “There has been…

November 2, 2018

Future market needs driving vendor innovation, says MilliporeSigma

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MilliporeSigma has brought together its next-generation technologies, both acquired and developed in-house, under the formalized BioContiuum platform. The offering looks to obtain incremental process benefits now, with a mind to the continuous process of the future, the firm says. MilliporeSigma’s BioContinuum platform, its self-described holistic approach to next-generation bioprocessing, is being launched at the AAPS event in Washington DC next week. Ahead of the event, Andrew Bulpin, head of Process Solutions at the vendor, told BioProcess Insider how the offering…

October 31, 2018

Biocon investing $200m into second MAb plant in India

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Construction is under way on a hybrid biomanufacturing plant at a site in Bangalore, set to support Biocon’s growing monoclonal antibody (MAb) portfolio. Indian drugmaker Biocon has a growing pipeline of biological products, including Ogivri, the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved by the US Food and Drug Administration (FDA) last December, and Fulphila, the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), approved in June. Both are marketed by Mylan, but including products developed in…

October 30, 2018

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

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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…

October 30, 2018