Author Archives: Gareth Macdonald

Quality cell banks de-risk regenerative medicine development, says consultant

Minimizing variability in cells used to make regenerative medicines is vital but challenging according to an expert, who says a quality cell bank is key. Cell and gene therapies have the potential to revolutionize medicine and allow physicians cure previously untreatable diseases. But developing a process that produces a stable, consistent product is a technical challenge. A major challenge is that the starting materials – the cells from which the medicines are produced – need to be carefully handled says…

Some cold chain issues with Pfizer’s COVID vaccine but US confident of supplies

US military officials say several trays of Pfizer and BioNTech’s COVID-19 vaccine needed to be replaced after being stored at excessively cold temperatures. Details of the replacement were disclosed yesterday during a press conference about efforts to roll out the vaccine. General Gustave F. Perna, who is running the US’ Operation Warp Speed (OWS), said some vaccine sent to California and Alabama was replaced after it was stored at a temperature lower than the recommended 70°C. “We had two trays…

Production begins at vector suite Catalent set up for Passage Bio

Catalent has started making viral vectors to support trials of PBGM01, a gene therapy for the rare lysosomal storage disease GM1 being developed by Passage Bio.  The US contract development and manufacturing organization (CDMO) set up a dedicated manufacturing suite at for Passage at its facility in Harmans, Maryland in August. Work since then has focused on bringing the suite online and validating it for the production of the AAVhu68 vector. The vector is used to deliver a modified DNA…

AstraZeneca’s $39bn Alexion buy will add meds and manufacturing capacity

AstraZeneca says buying Alexion will generate saving of $500m a year thanks to manufacturing and commercial synergies. AstraZeneca announced it would buy Alexion for a total consideration of $39 billion at the weekend, citing the latter’s capabilities in immunology as the primary driver for the deal. Coverage has focused on products Alexion will add to AstraZeneca’s pipeline with the monoclonal antibody-based blood disorder treatments Soliris (Eculizumab) and Ultomiris (ravulizumab) being the obvious examples. In its Q3 call Alexion said it…

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…