Author Archives: Gareth Macdonald

Orchard halts plant construction in shift away from ultra-rare diseases

Orchard Therapeutics has ceased work on a manufacturing plant in Fremont, California, reduced investment in some therapeutic programmes and cut its workforce by 25%. The gene therapy firm announced the changes last week as part of a strategic plan to shift focus from ultra-rare diseases to more common conditions. According to a document filed with the US Securities and Exchange Commission, Orchard plans to rely on contract development and manufacturing organizations (CDMOs) while it assesses potential development of in-house manufacturing…

UK Gov teams to aid academic gene therapy developers source vectors

Academics developing gene therapies often struggle to source vectors say the MRC and Lifearc, which plan to set up UK viral vector production network. The Medical Research Council (MRC) – a non-departmental government agency – and Lifearc – a research charity – announced plans for the network and a £16 million ($20 million) fund for the project on May 4. The idea is to provide grants UK-based research organizations can use to expand vector suites or repurposed facilities to make…

Pfizer, Sanofi, Novartis and Merck plants open during pandemic

Biopharmaceutical manufacturing is weathering COVID-19 relatively unscathed thanks to multi-sourcing strategies and newly available transport capacity. The coronavirus pandemic and the social distancing measures used to slow the spread of the virus have seen biopharmaceutical companies suspend trials and revise financial forecasts. Manufacturing, in contrast, appears to have suffered less impact judging by recent comments by leading manufacturers. For example, last week Pfizer CEO Albert Bourla told analysts the firms manufacturing sites and related distribution channels operational are operating “without…

UK tweaks GMP during pandemic and backs vaccine development

The MHRA relaxed its interpretation of GMP which means UK Biopharma firms have a reduced testing burden during the Covid-19 pandemic. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced the move last week, explaining the aim was to let drug firms focus quality system capacity on ensuring supply continuity. Under the plan, firms importing ingredients and finished products will only be required to test to confirm their identity. For other quality attributes importers are permitted to use…

Fujifilm Diosynth reserves space for Gates backed COVID-19 therapies

Fujifilm Diosynth Biotechnologies has agreed to dedicate space at its plant in Hillerod, Denmark to the COVID-19 Therapeutics Accelerator. Fujifilm Diosynth Biotechnologies (FDB) will work with a pharmaceutical partner to support the swift manufacture of a COVID-19 therapy for patients in lower-income countries. According to the contract development and manufacturing organization (CDMO) the deal includes drug substance manufacture along with supporting drug product (DP) and assembly, label and packaging of COVID-19 therapeutics. CEO Martin Meeson told us “Under the agreement,…

COVID-19 an opportunity for outsourcing sector, say leading CDMOs

COVID-19 has increased demand for outsourcing but it is too early to tell what long term impact the pandemic will have, say leading CDMOs. Lonza has received more than 40 inquiries about COVID-19 related projects, says CEO Albert Baehny. He told analysts the pandemic “has already offered some new and important opportunities, which are currently under review.” He added, “Inevitably we cannot engage and collaborate in all of those projects. Instead, we are focusing our efforts on selected key development…

Avectas attracts $20m to scale-up non-viral cell engineering tech

Avectas has secured funds needed to scale-up its cell engineering technology and expand its teams in the US and Ireland. Dublin-based Avectas attracted $20m of equity investment in a series C fundraising round completed on April 16. The firm plans to use the funds to scale up its Soluporation technology and to expand its commercial, regulatory and technical organization within Ireland and the US. CEO Michael Maguire told us “We will accelerate our translation and scale-up by engagement with external CDMOs and…

Refocused Seneca says cell therapy plant will support licensing plan

Seneca Biopharma has completed a stem cell-based therapy manufacturing facility to support clinical trials in Suzhou, China. The initial focus is Seneca’s candidate stem cell therapy, NSI-566, which is in a Phase II trial at the BaYi Brain Hospital in Beijing for chronic ischemic stroke. Thomas Hazel, Seneca’s senior vice president of R&D told us “The facility is designed to support clinical trial needs including our ongoing trial which will provide data this year in chronic ischemic stroke, not commercialization. “We…

Sanofi and GSK will use Flublok and AS03 tech to make coronavirus vaccine

Sanofi is aiming to manufacture hundreds of millions of doses of the coronavirus (SARS-COV-2) vaccine it is working on with GSK and BARDA and is targeting a late 2021 launch. Sanofi and GSK announced the deal on Tuesday, explaining they signed a letter of intent and a materials transfer agreement to assess the technical path to develop and produce a COVID-19 pandemic vaccine. Sanofi spokeswoman Marion Breyer said “Our goal is to initiate Phase I clinical trials in the second…

No official cases but North Korea looks to up coronavirus testing

North Korea has asked for help to increase COVID-19 monitoring capacity and has received reagents needed for testing, according to the WHO. Officially no COVID-19 cases have been reported in North Korea (DPRK). However, only a few hundred people have been tested for SARS-CoV2, the virus that causes the disease, according to World Health Organization (WHO) representative to DPR Korea, Edwin Salvador. “The WHO has been receiving weekly updates from the [DPRK] Ministry of Health on COVID-19. As of 2…