Author Archives: Gareth Macdonald

US FDA says platforms can speed COVID-19 jab development

COVID-19 focused drug and vaccine firms need to keep a close eye on the US FDA according to lawyers who predict manufacturing and trial rules will continue to change. The US Food and Drug Administration (FDA) issued its latest guidance for firms developing vaccines against SARS-CoV-2 – the virus that causes COVID-19 – last week. The document sets out what trial data vaccine firms will need to supply. It also makes clear developers will have to seek approval the traditional…

Instant caRNA? Tesla touts RNA bioreactor it is developing with Curevac

Curevac and car maker Tesla claim their development RNA production tech is less labour intensive and more deployable than alternatives. The technology – described as a Bioreactor for RNA in vitro Transcription – allows the DNA templates from which the RNA is produced to be used multiple times. It is also automated, which Curevac and Tesla say will minimize handling steps and make manufacturing processes more robust. The firms contrast their technology with current systems, which involve “many separate manufacturing…

CRISPR follows plant announcement with share offer

CRISPR Therapeutics will build a manufacturing facility in Framingham, Massachusetts to make cell therapies for trials and commercialization. The facility will accelerate its clinical development efforts according to CRISPR, which said it plans to hire up to approximately 100 full-time employees. CRISPR said the plant is being designed to provide GMP manufacturing in compliance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines. CEO Samarth Kulkarni stressed that the facility will not replace the…

CHO over? Biopharma and MIT team on alternative cell line R&D

Biogen, Amgen, Pfizer, Genentech and Sanofi have teamed with an MIT-led group aiming to develop new biomanufacturing cell lines and methods. The collaboration – known as the AltHost Consortium – will share research to explore innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Lead researcher Christopher Love from MIT likened the collaboration to the early days of the biopharmaceutical industry. “When biomanufacturing first emerged as a field, shared knowledge across laboratories was…

Emergent to add gene therapy capacity through $75m plant expansion

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector. The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts. At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000. Emergent said the investment will establish a multi-suite production operation with 1,000…

US FDA warns Takeda about Hikari plant

The US FDA has warned Japanese drug firm Takeda about its plant in Hikari, Japan after an inspection conducted last November. According to a letter from the regulator, inspectors who visited the site identified a number of problems with the facility’s quality control unit. The agency wrote, “Our inspection found that your Quality Unit (QU) did not take appropriate steps prior to resumption of aseptic manufacturing after a shutdown that included multiple significant activities that compromised cleanroom control.” It also…

Grifols to up capacity in North Carolina; starts making Covid-19 therapy

Grifols SA says it will spend $351.6 million to build a plasma facility and logistics center in Clayton, North Carolina. The investment – which was announced by the office of North Carolina Governor Roy Cooper – will create 300 jobs when the facility is operational. Operations at the new site will be focused on fractionation, the process of separating different components from blood plasma harvested from donors across the US. Grifols said the additional capacity will help cater for growing…

Mesoblast planning capacity hike if GVHD candidate is effective against COVID-19

Mesoblast says extra capacity will be needed to scale-up production of its GVHD candidate Ryoncil for use against COVID-19. When Australia’s Mesoblast raised $90m last month it said most of the money would be used to scale up production of its graft versus host disease (GVHD) candidate Ryoncil (remestemcel-L). CEO Silviu Itescu expanded on this last week, telling analysts the funds would be used to increase production of remestemcel-L in light of the coronavirus pandemic. “The proceeds from this offering…

Immobilize growth factors to cut cell therapy COGS say researchers

Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research. Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018. The surge in cell therapies entering the clinic is the “result of years of pioneering research by America’s biopharmaceutical research companies,” according to PhRMA. It also reflects the…

Oxford Biomedica to make AstraZeneca’s coronavirus vaccine for trials

Oxford Biomedica will make trial supplies of AZD1222 – AstraZeneca’s SARS-CoV-2 candidate vaccine – under a deal agreed this week. The cell and gene therapy contractor will make the adenovirus vector-based vaccine at its recently established manufacturing facility – known as Oxbox – at the Oxford Science Park in Oxford, UK. The agreement – which is for one year – will see Oxford Biomedica supply AstraZeneca with multiple batches of vaccine, the majority of which are expected to be produced…