Author Archives: Gareth Macdonald

Reliance on antiquated tech a business risk for CGT sector

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Cell and gene therapy firms should swap outdated human error prone processes for innovative, flexible technologies, says consulting group CRB. The conclusion is based on the ‘Cell and Gene Therapy Industry Report,’ which included a survey of executives at firms developing advanced therapy medicinal products (ATMP). The goal was to look at the technologies and manufacturing methods used in the sector and the results suggest the sector has yet to find the best way of making products at commercial scale.…

November 16, 2020

Repligen up on COVID-19 and gene therapy related demand

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COVID-19 related demand helped Repligen in Q3 with the emerging gene therapy sector also providing a revenue boost. The processing technology firm’s revenue reached $94.1 million for the three months ended September 30, up 35% year-on-year. Gross profits also increased, climbing 40% to $54.5 million. Repligen attributed the gains to increased demand for its technologies from companies working on SARS-CoV-2 vaccines or related therapeutics. CEO Tony Hunt told analysts “We estimate that COVID programs accounted for approximately 55% of our…

November 10, 2020

Test continuous manufacturing tech with real processes, says expert

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Continuous processing technologies and methods should be tested with actual production processes says Tom Ransohoff from CDMO 4th Dimension Bioprocess. Continuous-mode manufacturing has been a hot topic for the drug industry for the past few years but, as yet, few companies have fully embraced the approach and even fewer have switched from fed-batch production. But the change is coming according to Tom Ransohoff, COO at recently founded CDMO 4th Dimension Bioprocess, who told delegates at the BPI East conference in…

November 9, 2020

Pfizer building clinical trial supply plant as part of €300m Ireland expansion

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Pfizer will build a plant in Ringaskiddy, Cork to support its clinical trials as part of a €300 ($355) million investment in Ireland. The US drug giant announced it would expand capacity in Ireland this week, explaining the investment included the initial stage of a project to construct the clinical trial supply facility at its existing Ringaskiddy site. A spokesman told us “This type of activity is highly specialized manufacturing working with our global research and development group. The initial…

November 6, 2020

CRISPR, reagents, cell lines: PerkinElmer buying Horizon Discovery

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PerkinElmer will buy Horizon Discovery Group for $383 million to add CRISPR gene editing and RNAi tech to its offering. As well as gene editing, the deal will also add Horizon’s reference standards, screening technologies and manufacturing cell lines to PerkinElmer’s portfolio. Buying Horizon will enable PerkinElmer to better address market needs says Alan Fletcher, vice president and general manager of life sciences. “A combined PerkinElmer Horizon offering positions the Combined Group as a provider of complete workflows for researchers…

November 3, 2020

Catalent bones up on CGTs with Skeletal Cell Therapy buy

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Catalent has agreed to buy Bone Therapeutics’ manufacturing unit – Skeletal Cell Therapy Support SA – and make trial supplies of the candidate bone disease cell therapy, ALLOB. The contract development and manufacturing organization (CDMO) will pay €12 million ($14 million) for Skeletal Cell Therapy Support SA (SCTS), which operates a 3,800 square meter manufacturing facility, development lab and warehouse at the Brussels South Charleroi Biopark, in Belgium. The site produces Bone’s allogenic cell therapy candidate ALLOB, which has been…

October 29, 2020

Sartorius revises 2020 forecast on bioprocess solutions and lab services growth

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Sartorius has raised its guidance citing growing demand for bioprocessing tech and lab services and the positive impact of acquisitions. Group revenue for the nine months to the end of September was €1.68 billion, up 23.9% on the comparable period last year. Bioprocess Solutions generated €1.28 billion, up 27.7%, while laboratory products and services brought in €391 million, up 13%. Sartorius said a general increase demand and the positive impact of recent takeovers were the major drivers. The COVID-19 pandemic…

October 23, 2020

EMA committee nod for Orchard’s Libmeldy positive for AGC Biologics

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AGC Biologics looks set to start making Orchard Therapeutics’ Libmeldy after an EMA panel recommended the gene therapy be approved. The agency’s the Committee for Medicinal Products for Human Use (CHMP) recommended approval last week, explaining Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene) slows down progression of the lysosomal storage disease, metachromatic leukodystrophy (MLD). Orchard CEO Bobby Gaspar welcomed the recommendation. He said it “brings us closer to delivering a one-time, potentially transformative therapy for eligible…

October 21, 2020

Single-use tech helps give emerging biotechs flexibility says Macrogenics

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Flexibility is vital for growing biopharmaceutical companies says Macrogenics, which used single-use tech to accelerate development of its Phase III manufacturing plant. Like many younger biotechnology companies, Macrogenics initially focused on product development rather than investing in production capacity. The Maryland firm was incorporated in 2000, however, it did not set up its first manufacturing facility until 2005. The plant was designed to manufacture candidates for Phase I/II trials and had limited capacity. Initially it could only carry out four…

October 19, 2020

Tech used for new Ebola drug key to COVID-19 fight, Regeneron

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Regeneron says rapid response technologies pioneered to combat Ebola are helping accelerate efforts to create COVID-19 countermeasures. Last week Regeneron won US FDA approval for Inmazeb (atoltivimab, maftivimab and odesivimab-), its treatment for Zaire Ebola. The product is made from three monoclonal antibodies that target the Ebola glycoprotein, preventing the virus binding and infecting cells. Regeneron created Inmazeb using the same rapid response manufacturing platform it is currently using for RGEN-COV2, its COVID-19 treatment candidate. Shawn Lawrence, senior director, cell…

October 16, 2020