Author Archives: Gareth Macdonald

Single-use tech “unstoppable” if suppliers can meet soaring demand, says GSK

COVID-19 has further increased already soaring demand for single-use tech according to a GSK expert who says boosting supply is key. Most biopharmaceuticals are made in stainless steel systems. But the past decade has seen interest in using disposable single-use systems increase. Initially the focus was in clinical supply. However, as Weibing Ding, director of GSK Pharma in King of Prussia, Pennsylvania told BPI East virtual conference delegates, a growing number of companies are trialing single-use systems for commercial-scale production.…

Pfizer to make Vivet’s Wilson disease gene therapy for Phase I/II trial

Pfizer will make a candidate gene therapy for the liver condition Wilson disease under an agreement with Vivet Therapeutics. The US pharmaceutical firm will make supplies of the candidate – known as VTX-801 – for a Phase I/II clinical trial due to start early next year. Wilson disease is characterized by the accumulation of copper in tissue. It is an inherited disorder caused by mutations in the gene encoding the ATP7B copper transporter. VTX-801 is an AAV liver tropic capsid…

Biopharma set for COVID-related single-use shortages, says survey

Biopharma faces delays obtaining single-use systems according to a survey that suggests disruption caused by the COVID-19 pandemic and increasing demand will result in shortages. Single-use bioprocessing technologies now dominate the pre-commercial manufacturing space according to research by Bioplan Associates. The organization quizzed 130 executives at biopharma firms and contract development and manufacturing organizations (CDMOs) and 150 tech suppliers and found that demand for single-use systems (SUS) has continued to increase in recent years. According to Bioplan managing partner Eric…

Catalent investing $130m to up US gene therapy capacity

Catalent will add five additional Phase III through to commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland. The US contract development and manufacturing organization (CDMO) cited growing customer pipelines and an increase in demand as the driver for the investment. Randy Hendrickson, VP Commercial Operations, Catalent Cell & Gene Therapy told us: “Upon completion in the first half of 2022, the facility will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing,…

VMIC to help Oxford Biomedica up capacity for AstraZeneca AZD1222 deal

Oxford Biomedica will make extra production suites at its Oxbox facility available to AstraZeneca to service an expanded coronavirus vaccine manufacturing agreement. AstraZeneca originally hired UK-based contract development and manufacturing organization (CDMO) Oxford Biomedica for the commercial production of the vector-based COVID-19 vaccine candidate, AZD1222 in May. Last week, the Anglo-Swedish biopharmaceutical firm paid an additional £15 million ($20 million) upfront to reserve up to three more manufacturing suites for 18 months. The deal can be extended by mutual agreement.…

Catalent cites biologics as growth driver and forecasts COVID gains in 2021

Catalent says investments in biologics – particularly in the cell and gene therapy space – drove Q4 gains and positioned it as the “go to” COVID CDMO. Catalent’s revenue for the three months ending June was $947.6 million, up 31% on the comparable quarter last year. The contract development and manufacturing organization (CDMO) made a number of purchases in the cell and gene therapy space in recent years. In February, it bought Masthercell from Orgenesis and in 2019 it acquired…

Mesoblast talks Ryoncil, COVID-19 and manufacturing capacity

Mesoblast has sufficient capacity to launch Ryoncil for GVHD but will need to scale-up if the cell therapy works against COVID-19. The Australian firm outlined its manufacturing plan for Ryoncil and other candidates last week during its Q4 call. Ryoncil (remestemcel-L) is a candidate cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The product recently received the green light from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC), which recommended it be approved…

New technologies can solve downstream bottlenecks says expert

Biopharma needs to embrace new downstream processing technologies to overcome its manufacturing issues, according to an expert. Industry is reluctant to adopt new downstream technologies because firms prefers systems with which staff are familiar, said Alois Jungbauer from the Austrian Centre of Industrial Biotechnology at the University of Natural Resources and Life Sciences. He began by asking delegates at the BPI Europe virtual conference in July: “Why is chromatography so popular? “It’s the high selectivity. It’s the high resolution. We…

Automation can help biopharma enjoy the benefits of continuous processing says CPI

Automation can eliminate downstream bottlenecks and help pharma cut costs says the team behind a continuous downstream processing system at the UK Centre for Process Innovation. Manufacturing biopharmaceutical is a complex, time consuming and costly process. Most products are produced in batches – production runs through a series of steps and then ends. Batch production is reliable and able to make consistent product. However, it can be slow and expensive according to Stuart Jamieson, head of research at the CPI,…

Agilent predicts $750 million global oligo market by 2025 and ups capacity

Agilent Technologies has announced plans to more than double nucleic acid-based drug production capacity at its facility in Frederick, Colorado. The research, development and manufacturing company said it will invest $150 million to add 25,000 square feet of capacity. Agilent cited the growing market for “oligos” as the driver for the investment, predicting it will grow in double digits and be worth more than $750 million by 2025. Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said, “Adding this higher-volume…