Author Archives: Gareth Macdonald

WuXi ATU opens Philly cell and gene therapy testing center

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WuXi ATU has opened a testing facility in Philadelphia, US to cater for growing demand for the cell and gene therapy sector. The new test center expands the campus that WuXi ATU – a subsidiary of WuXi AppTec – established late in 2020. A company spokesman told us “The new Philadelphia facility will enable us to triple our capacity for critical tests related to the characterization of lentivirus and adeno-associated-virus (AAV) products such as replication competency (RCL and RCAAV assays)…

December 7, 2021

Resilience buys cell free synthesis tech firm SwiftScale Biologics

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Resilience has bought cell-free protein synthesis tech firm SwiftScale Biologics in a deal designed to support novel therapeutic research. The San Diego based contractor – officially called National Resilience – announced the acquisition late last week, citing growing biopharmaceutical industry interest in cell-free protein synthesis as the prompt for the deal. Resilience CEO Rahul Singhvi suggested the approach could help industry overcome some of the hurdles that complicate commercial manufacture and scale-up. “Biologics production today is limited to what can…

December 6, 2021

Fujifilm to invest $500m+ in UK CDMO business

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Fujifilm Corp has confirmed £400 ($532) million of a previously announced investment program will be spent expanding its CDMO operations in Billingham, UK. According to a plan unveiled today Fujifilm will double the sites development and manufacturing capabilities, establish both a viral gene therapy facility and a mammalian cell culture facility and create up to 350 jobs. Fujifilm Diosynth Biotechnologies will also build a cell culture facility and ramp up antibody-based therapeutics production capacity through the addition of four 2,000…

December 2, 2021

COVID-19 to shape mRNA vaccine and therapeutic sector for years to come

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COVID-19 established mRNA vaccines as an effective therapeutic option and – says a technology expert – has set the blueprint for how they will be made for the foreseeable future. Developers were working on mRNA-based medicines before 2020 with Alnylam’s polyneuropathy treatment Onpattro (patisiran) being one of the first such therapies to win approval. However, the COVID-19 pandemic prompted a period of rapid growth for the market – particularly mRNA vaccines – that shows little signs of slowing according to…

November 24, 2021

Generate Biomedicines raises $370m to advance AI drug discovery tech

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Generate Biomedicines has raised $370 million to further develop its artificial intelligence (AI) drug discovery technology, expand its team and build labs. The Cambridge, Massachusetts biotech completed a series B round last week, attracting investment from founding backer Flagship Pioneering and the Abu Dhabi Investment Authority (ADIA), the Alaska Permanent Fund and Altitude Life Science Ventures. Generate said the money will allow it to “advance and evolve†the platform and “scale the organization with top-tier scientific and computational talent.†It…

November 22, 2021

COVID drove innovation in consumables sourcing and inventory management

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COVID-19 has changed how drugs and vaccines are made according to experts who say limited raw material supplies and manufacturing capacity have forced industry to innovate in sourcing and inventory management. The pandemic has disrupted the global supply of consumables and technologies according to Josh Speidel from Latham BioPharm Group, who said on BioProcess Insider’s recent State of the Industry webinar that delivery timelines have increased significantly. “The pandemic has put immense pressure on the global manufacturing capacity†adding that…

November 19, 2021

eBook: Vaccines Revisited — The Past, Present, and Future of Nucleic-Acid Vaccine Production

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The quarterly BioProcess Insider eBook series launched in 2021 to investigate specific modalities and business strategies driving the biopharmaceutical sector based upon trends and discussion points presented in the Insider’s pages. Two of the four quarterly publications — this one included — have focused on the vaccine industry. If the series had launched in 2019, cell and gene therapies might have warranted a double edition, or perhaps investments in antibodies and antibody fragments would have driven a bispecific focus. Five…

November 16, 2021

COVID hit cell and gene therapy trials and suppliers but experts see signs of recovery

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COVID-19 disrupted cell and gene therapy trials as well as the contractors and suppliers that support them, according to experts. SARS-CoV-2, the virus that causes COVID-19, impacted all parts of biopharma. For example, the focus on vaccines highlighted manufacturing capacity limitations while increased demand for consumables and raw materials put pressure on suppliers. The pandemic also disrupted R&D to the extent that some developers put projects on hold according to Amelie Boulais, head of market entry strategy at Sartorius, who…

November 16, 2021

Lose the LIMS? Bristol Myers says QC labs of the future need to be digital

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Drug quality control labs of the future will need to be more closely integrated with manufacturing operations and make greater use of data management tech and automation, says an industry expert. Quality control is a vital part of ensuring drugs are safe, effective and can be produced consistently. However, despite understanding this importance, manufacturers have often focused on improving manufacturing processes rather than QC labs according to Steve Muller from Bristol Myers Squibb (BMS), who says firm’s looking to digitize…

November 1, 2021

Regeneron says tech was key to rapid COVID-19 mAb cocktail dev

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Efforts to combat COVID-19 were aided by a platform-based approach says Regeneron, which cites its mAb and cell line technologies as key to the process. REGEN-COV, Regeneron’s antibody cocktail reduces the risk of COVID-19-related hospitalization and death by 71 percent and lowers viral loads faster than a placebo according to data recently published in the NEJM. REGEN-COV is a combination of casirivimab and imdevimab. It was developed in less than a year, which is much faster than comparable therapies. Typically,…

October 28, 2021