Author Archives: Dan Stanton

Avantor upping single-use capacity by 30% in response to huge demand

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Avantor says investments in facilities in North Carolina, Massachusetts, and The Netherlands will help feed the surge in demand for single-use equipment driven by a robust biologics sector and the COVID-19 pandemic. Sean DeFusco, general manager of single-use solutions/fluid handling at Avantor, told BioProcess Insider the firm will increase its single-use manufacturing footprint by 30% in the United States and Europe along with doubling cleanroom space. “So far, we expanded our Morrisville, North Carolina single-use facility and we’re nearing completion…

May 4, 2021

Single-use lead times up to 12 months as COVID takes its toll

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Some biomanufacturers are waiting up to a year for single-use equipment, according to ABEC. And while vendors are expanding capacity these projects will take months to come online. Early in the COVID-19 pandemic, single-use bioprocess systems and materials were highlighted as necessary tools in the development and commercial manufacture of potential vaccines and therapies. The speed and flexibility needed to make novel vaccines, including mRNA, DNA, and viral vectors, meant those platforms were largely built on single-use technologies. Coupled with…

May 3, 2021

GMP deficiencies disrupt production of ERC’s cell-based vaccine

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European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],†the…

May 3, 2021

Emergent recognized cross contamination risk at Bayview plant hit with 483

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Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task†of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

April 30, 2021

Lonza’s alleged need for Nestlé staff highlights shortage in biopharma talent

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Neither company will confirm reports that Nestlé staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm Nestlé in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers†following an intervention by the Swiss government aims at…

April 29, 2021

Vendors continuing to reap the COVID windfall

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Danaher expects COVID-19 vaccine and therapy-related revenue for its bioprocess businesses Pall and Cytiva to reach $2 billion, while the pandemic fuelled “an exceptionally strong start†to Sartorius’s 2021. In June last year, the evolving coronavirus pandemic was marked out as a $14 billion opportunity for bioprocess vendors by analysts. Ten months on, with several vaccines and therapies being used commercially and several more moving through the clinic, the service firms are experiencing unprecedented demand for their equipment and tools…

April 28, 2021

ADC Therapeutics joins conjugate elite with Zynlonta FDA approval

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The US FDA has approved Zynlonta (loncastuximab tesirine), the eleventh antibody-drug conjugate and the first for ADC Therapeutics. Zynlonta received the thumbs up from the US Food and Drug Administration (FDA) last week for the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The antibody-drug conjugate (ADC) is composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-based cytotoxic warhead. PBDs are a class of compounds…

April 27, 2021

Chinese CDMO sector growing but unlikely to make global impact

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China’s contract manufacturing space is growing at over 15% year-on-year but only WuXi Biologics has seen success in attracting global clients, says BioPlan Associates ahead of CPhI Discover. Third-party drug manufacturing is relatively new in China. Only since 2015 has a market authorization holder (MAH) system been in place, opening the doors through further reforms for commercial contract development and manufacturing organizations (CDMOs) to operate in the country. In 2019, China approved Hodgkin’s lymphoma drug tislelizumab – the first CDMO-made…

April 26, 2021

Bayer confirms $200m Berkeley cell therapy facility

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The Cell Therapy Launch Facility will support Bayer’s growing advanced therapy ambitions and comes in addition to a $1.2 billion investment in the Californian campus. Bayer has confirmed it is expanding its cell and gene capabilities through the addition of a Cell Therapy Launch Facility, which is set to join a Cell Culture Technology Center (CCTC) and Cell & Gene Therapy labs coming on-line later this year at its 46-acre campus in Berkeley, California. “The Cell Therapy Launch Facility is…

April 26, 2021

Pfizer mRNA risk paying off as it moves to make 3bn doses of COVID jab

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Pfizer says it will produce 3 billion doses of its COVID-19 vaccine this year and will further invest in its manufacturing network to support continued global demand. Through its partnership with BioNTech, Pfizer became the first company to bring a messenger RNA-based product to market, namely the COVID-19 vaccine Comirnaty (BNT162b2). Last month, the firm estimated it was set to make around $15 billion from global sales of the vaccine this year, based on production projections of 2 billion doses.…

April 23, 2021