Author Archives: Gareth Macdonald

Sinovac raises $500m to fund Coronavac trials and production

Sinovac Biotech has secured financing of $500m to fund further development of its candidate COVID-19 vaccine. The funding – which gives investor Sino Biopharma a 15% stake in the Beijing biotech – will be used to support clinical development of Coronavac, a vaccine that uses inactivated forms of COVID-19 to induce immune responses. Sinovac is conducting large-scale clinical trials of the vaccine in Brazil – the study was suspended in October before resuming last month – and Indonesia. In November…

Cell therapy process control requires a rethink, says expert

Autologous cell therapy production is a challenge and control strategies developed for protein drugs may not work, says an expert. The biopharmaceutical industry has been making therapeutic proteins for forty years. The unit operations and methods are well established and effective. Firms know how to control production to ensure the finished medicine is of appropriate quality. Industry has less experience making therapies from cells harvested from patients and this is a problem according to Rachel Yost, senior process engineer at…

Moderna working 24/7 on COVID-19 vaccine manufacture and supply

Moderna is confident its supply and distribution chains are robust enough to support COVID-19 vaccine scale up and roll out. The vaccine – mRNA-1273 – consists of mRNA coding for the SARS-CoV-2 spike protein inside a lipid nanoparticle. It is seen, along with jabs being developed Pfizer and AstraZeneca, as one of the best hopes for combatting the pandemic. So when clinical trial data released in November showed mRNA-1273 was 94.1% effective at protecting people from SARS-CoV-2, the news was…

64x claims cell screening tech is breakthrough for global vector supplies

64x bio says a new cell screening technology has the potential to make viral vector production more efficient. The San Francisco-headquartered biotechnology’s “VectorSelect” platform is a high throughput screening technology designed to help viral manufacturers identify high yield production cell lines. 64x bio says the system’s key feature is “genetic barcoding,” which links information on viral vector productivity to the parent cell allowing users to screen millions of candidate production cell lines at once. The aim is to help firms…

Rubius touts shelf life of cancer therapy, citing manufacturing process

Rubius Therapeutics has shared details of the manufacturing process for RTX-321, a candidate cell therapy for HPV positive cancers that it says is a “truly” off the shelf product. The US biotech made the claim in an IND filed with the FDA earlier this month. It said the “filing for RTX-321 included, for the first time, frozen drug substance as part of the manufacturing process, resulting in a truly off-the-shelf cellular therapy with a potential shelf life of up to…

Iovance plant on track for 2022 and lifileucel BLA set for next year

Iovance Biotherapeutics says its new cell therapy plant in Philadelphia is on track to begin commercial production in 2022. The firm updated on development of the facility at the Navy Yard complex in Philadelphia during its Q3 earnings call, telling analysts clean rooms are due to be operational for clinical trial supply production in 2021. Iovance announced plans for the $125 million Philadelphia facility in May last year, explaining it would be used to make autologous TIL products including lifileucel…

Catalent reiterates confidence in the gene therapy sector

Gene therapies will help drive growth says Catalent, which reiterated its confidence despite recent setbacks in the sector. The contract development and manufacturing organization (CDMO) spoke about its growing gene therapy business during its first quarter earning call last week, explaining it is seeing ongoing “elevated demand” for this type of work. Revenue generated by Catalent’s biologics business – which covers biopharmaceutical manufacturing as well as cell and gene therapy production – was $377.1 million in the first quarter of…

Reliance on antiquated tech a business risk for CGT sector

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.…

Repligen up on COVID-19 and gene therapy related demand

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…

Test continuous manufacturing tech with real processes, says expert

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…