Experts are calling on industry to respond to proposed rules restricting perfluoropolymers – commonly considered ‘forever chemicals’ – which are used in virtually all biomanufacturing processes. The European Chemicals Agency (ECHA) is looking to implement a series of restrictions on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFAS). Multiple other jurisdictions are also proposing similar restrictions. “Virtually all bioprocesses for biotherapeutics and vaccine manufacturing depend somewhere in the process on these materials, which include…

The acquisition will bring Sartorius a range of transfection reagents and plasmids and, at €2.4 ($2.6) billion, is the largest bolt-on for the bioprocess vendor. The deal announced Friday will see Sartorius subsidiary Sartorius Stedim Biotech (SSB) buy France-based Polyplus, adding a range of components used in the production of viral vectors and around 270 staff members. René Fáber, who recently tookover as CEO of SSB from Joachim Kreuzburg, described Polyplus’ offerings as “highly complementary to our portfolio, in particular…

Despite recent expansions at its single-use technology (SUT) production facilities in Utah, Thermo Fisher is preparing to lay-off staff due to “macro-economic conditions.” Bioprocess vendor Thermo Fisher has seen a string of investments across its global production network. In Utah, specifically, the firm expanded capacity at a BioProcess Container (BPC) facility in Logan in late 2020, and – just last year – opened a 55,000 square-foot single-use technology (SUT) facility in Ogden. While the latter expansion saw Thermo Fisher hire…

Process analytical technology (PAT) can help cell and gene therapy developers better understand and control product manufacture. But, to date, use has been limited according to researchers, who say the sector needs more purpose-built monitoring technologies. The conclusion comes from a study looking at how machine learning and metabolic modelling can be used to use process analytical technology in cell and gene therapy manufacturing. According to the authors “Process analytical technology (PAT) has demonstrated huge potential to enable the development…

Drugmakers using continuous manufacturing (CM) should ensure design measures are in place to demonstrate the acceptability of all cell culture material used to generate biologic drug substances. Endorsed by the International Council for Harmonization (ICH) Assembly in November 2022, the final guidance issued by the US Food and Drug Administration (FDA) entitled Continuous Manufacturing of Drug Substances and Drug Products aims to help industry develop, implement, and operate lifecycle management processes for continuous manufacturing (CM). Much of the guidance (reproduced…

End-to-end fully automated in vitro transcription (IVT) reactions can increase process throughput in the development of messenger RNA (mRNA) vaccines and therapeutics, says Pfizer. Among the discussions centering on bioprocess automation at the BPI West Conference in San Diego, California this week was Pfizer’s reflection on its latest research into a fully automated and streamlined IVT reaction. IVT is used to transcribe genetic information from DNA to RNA, and the generated mRNA transcript is used to produce proteins in cells. Karena Smith,…

Sartorius invested €593 ($647) million in its global capacities in 2022 and says it is planning similar this year. For the full year 2022, Sartorius reported total sales of €4.17 billion, representing a 21% increase on the previous year. The firm’s Bioprocess Solutions business pulled in €3.32 billion of this and saw a 22% growth year-on-year. The firm reiterated how the skew of COVID-19 related revenues and demand normalization will drive down sales going forward, with CEO Joachim Kreuzburg forecasting…

Independent technology and product development company TTP  announced the launch of spin-out company Cellular Origins during Advanced Therapies Week in Miami, Florida. TTP launched Cellular Origins to develop a commercial manufacturing platform that will enable biopharmaceutical companies to increase scale dramatically for advanced cell and gene therapy (CGT) production, addressing the difficulties that developers have in meeting manufacturing demand. Matthew Carr, head of life sciences at TTP, said, “We have every confidence that Cellular Origins will deliver on its mission…

Vendors are feeling the economic impact of dwindling COVID-related bioproduction, but Thermo Fisher and Danaher remain unfazed, the firms said at JPM 2023. Many bioprocess vendors reported falling orders in the latter half of 2022 as biopharma reduced stock orders for vaccine and therapeutics following two years of unprecedented pandemic-related growth. This bioprocess destocking dynamic – described by some as a “swift normalization of demand” – was brought up at this week’s JP Morgan Healthcare Conference in San Francisco but…

Aslan Pharmaceuticals has contracted Thermo Fisher to produce its atopic dermatitis candidate eblasakimab. Aslan’s lead candidate eblasakimab is being developed to treat atopic dermatitis (AD), the most common form of eczema. The monoclonal antibody (mAb) targets the IL-13 receptor α1 subunit (IL-13Rα1), which prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13), the key drivers of inflammation, central to triggering symptoms of allergy in atopic dermatitis, such as redness and itching of the skin. The agreement will see…