Author Archives: Gareth Macdonald

Rooster Bio and Sartorius team to streamline hMSC production

Cell bank firm Rooster Bio has teamed with Sartorius to find ways of scaling-up production of stem cell-based regenerative therapies. The collaboration will combine Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools. The aim is to provide “robust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes, allowing product developers to significantly speed up their development timelines,”…

Pall investing $114m, adding 1,100 jobs, on back of COVID single-use demand

Pall Corporation will invest $114 million to increase global production capacity for single-use bioprocessing systems in response to COVID-19 related demand. The firm will add capacity at its facilities in Medemblik in the Netherlands, Hoegaarden in Belgium, Bad Kreuznach in Germany, Ilfracombe and Newquay in the UK, Fajardo in Puerto Rico, and Pensacola in the US. Pall cited “industry demands driven by COVID-19” as the driver for the investment adding that it expects to create 1,100 jobs globally now through…

Bayer joins Wacker and Fareva in CureVac’s COVID-19 vaccine network

CureVac has hired Bayer to help develop mRNA-based medicines including the COVID-19 vaccine candidate, CVnCoV. Under the deal – financial terms of which were not disclosed – Bayer will provide development support, manufacturing, guidance on clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance. A CureVac spokesman told Bioprocess Insider “The present agreement does not include manufacturing on Bayer´s side. However, Bayer is currently evaluating all options to support manufacturing of CureVac’s COVID-19 vaccine.” The agreement specifies that…

Fujifilm invests in third viral vector plant citing ‘surging’ demand

Fujifilm says surge in demand for viral vectors prompted decision to invest in third development and production plant. Fujifilm announced plans to invest $40 million to set up the new plant in in Watertown, Massachusetts last week. The Japanese conglomerate’s contract services unit – Fujifilm Diosynth Biotechnologies – will run the facility when it comes online. In a press statement the CDMO’s CEO Martin Meeson said, “We are strategically establishing this facility in the greater-Boston area where there is a…

WuXi to make COVID-19 vaccine at shelved Bayer hemophilia drug plant

WuXi Biologics will make components of COVID-19 vaccines and other biologic products at the facility it bought from Bayer. The Chinese CDMO acquired the plant in Wuppertal, Germany last month in a deal valued at around €150 million ($185 million). Bayer had originally planned to use the Wuppertal plant to produce recombinant factor VIII products. However, in November 2018 the firm announced it would not commission the facility. A Bayer spokesman told us “the decision was based on a review…

COVID-19 has spurred long-lasting innovation, says expert

Biopharma must learn from COVID-19 and make sure it has capacity to respond to future pandemics, according to biobanking firm GoodCell. SARS-CoV-2 has killed more than 1.6 million people worldwide and sickened millions more in the 12 months since it was first detected. The virus has disrupted almost every industry and prompted Governments to introduce strict measures to try and slow its spread. But the virus has also been a catalyst for innovation. From the use of internet conference technologies…

Singapore sets sights on soaring stem cell demand

Singapore’s A*star wants to use micro-carrier tech to capture a share of the global stem cell manufacturing market. Demand for stem cells has increased markedly in recent years, creating a significant opportunity for those willing to innovate to help industry address its manufacturing challenges according to Steve Oh from A*star. “In a bid to do that, the Singapore government invested $80 million in three programmes to manufacture living cells as medicines,” Oh told delegates at the Cell and Gene Therapy…

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…