Author Archives: Gareth Macdonald

Sino Biological to build manufacturing and CRO services unit in Texas

Shenzhen stock exchange-listed Sino Biological has leased land to build a bioprocessing center and CRO in Levit Green, Houston. The new facility – which will be at a site leased from the real estate investment, development, and property manager Hines – will focus on product manufacture and the provision of contract research services. The aim is to provide drug industry sponsors and academic researchers working in the region with access to “bioreagents and CRO services” says Rob Burgess, Sino Biological’s chief business…

Cell and gene therapy regulations moving in right direction says ARM

PDUFA VII will help clarify CMC requirements for cell and gene therapy firms according to the Alliance for Regenerative Medicine (ARM), which says regulations around such products are moving in the right direction. The Prescription Drug User Fee Act (PDUFA) VII – legislation that enables the US FDA to collect use fees from drug developers and strengthens the agency’s review capabilities for small and large molecule drugs and advanced therapeutics – covers the fiscal years 2023 to 2027. Cell and gene…

Making facilities commercialization-ready is next big challenge for CGT sector

Bulging late-stage R&D pipelines suggest many in the cell and gene therapy sector are preparing to go market. For such firms, having the right manufacturing infrastructure will be vital for commercial success, says Ken Green from Vertex. Commercializing a cell or gene therapy is a complex process. Once a therapy is approved, the developer has to manufacture it and bring it to market in a stable and sustainable way. “The big question for us as an industry is how are…

Cell and gene sector expanding at ‘astonishing pace,’ say researchers

Kymriah and Yescarta may have finally established the commercial viability of cell and gene therapies, but it is advances in manufacturing and distribution that define the market, according to new analysis. The research – published in the journal Cytotherapy in October – looked at innovation in cell and gene therapy research, in particular in cancer which has been a very active area for developers according to the authors. “With the early successes of ex vivo–expanded, autologous tumor-infiltrating lymphocytes (TILs) in patients…

Catalent cuts full year forecast citing COVID, currencies and costs

Catalent has cut its 2023 forecast after lower COVID-19 related product demand, inflation and currency headwinds impacted Q1 biologics revenue. The contract development manufacturing organization (CDMO) reported revenue for the three months ended September 30 of $1.02 billion, roughly the same as it was in the comparable period in 2021. Meanwhile, net income fell 52% to $61 million. The contribution from Catalent’s biologics business – which includes large molecule drug development and manufacturing as well as cell and gene therapies…

Finding CHO cell lines for mAbs too slow, say researchers

Chinese hamster ovary cells may be the foundation of modern biopharmaceuticals but the process of finding high-producer clones is too labor intensive, according to new research. The study – published in the Journal of Bioscience and Bioengineering in March – examined how the biopharmaceutical industry is using CHO cells and identified clone selection as a remaining challenge for the industry “CHO cells are widely used for constructing expression systems to produce therapeutic proteins. However, the establishment of high-producer clones remains a laborious and…

Supply chain weight grows as CGTs reach ‘critical inflection point’

Cell and gene therapy developers should start planning manufacturing and supply chains at least three years ahead of commercial launch, according to new analysis. The research – by consulting group McKinsey – said the cell and gene therapy sector is at a “critical inflection point” with regards to bringing products to market and sought to identify steps likely to increase the chance of a successful launch. And the key finding is that products for which the supply chains are planned…

FDA creates advanced therapies ‘super office’ to meet higher demand

The US FDA office tasked with overseeing cell and gene therapies has been renamed and reorganized in response to increased submissions. The changes – details of which were published in the Federal Register last week – saw the ‘Office of Tissues and Advanced Therapies’ become the ‘Office of Therapeutic Products (OTP)’ and will be designated as a ‘super office’ that will manage its program at a macro level. The changes – which came into effect on September 16 – will…

Process tech data standards would help biopharma digitize, Siemans study

Drug makers need data standards to realize the full benefits of digital manufacturing tech, according to new analysis. The research – by German technology conglomerate Siemens – focused on how digital systems are reshaping the production of medicines with the authors quizzing executives from 31 firms in the UK and Ireland about changes over the past two years. And the key finding is that biopharmaceutical firms need data standards according to the authors, who cite integration as a major challenge…

Gene therapy firms must consider patients when choosing rAAV production systems

Gene therapy developers need to carefully assess their choice of production platform to make sure it best fits likely demand, clinical timelines, and target patient population size. The advice comes from a study in Current Opinion in Biotechnology that looked at the pros and cons of currently available recombinant adeno-associated viral vector (rAAV) based production systems. The authors compared transient transfection (TT) – which is the most widely used rAAV manufacturing methods – with baculovirus expression vector (BEV) based systems…