Author Archives: Gareth Macdonald

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…

Orgenesis signs muscle-derived stem cell pact with Revatis

Orgenesis has added muscle-derived stem cells to its offering through a manufacturing joint venture with Revatis. The partnership will supply developers of autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells (mdMSCs). The firm told us “The objective is to spin-off Revatis technology developed in the vet field into the human field; the JV  is currently planned to be  called “REVACEL. “After technology transfer, REVACEL will conduct development of muscle derived MSCs first and then as sourcing of…

Establish gene therapy tech early says Daiichi as it inks Ultragenyx deal

Daiichi Sankyo has licensed a commercial-scale gene therapy manufacturing technology from Ultragenyx Pharmaceutical in a $200m deal. The Japanese firm will use Ultragenyx’s HeLa producer cell line and HEK293 transfection system for adeno-associated virus (AAV) manufacture in its gene therapy development programs. Masayuki Yabuta, head of Daiichi’s biologics division, set the deal as part of a wider investment in the firm’s gene therapy business. “In order to provide these drugs to patients in the future, manufacturing technology must be established…

Takeda, CSL and others working on plasma-derived COVID-19 therapies

Takeda says COVID-19 therapy accord will work on TAK-888 and other plasma-derived meds developed by its partners. The Japanese drug firm teamed up with CSL Behring, Biotest, BPL Group, LFB and Octapharma this week. The aim is to turn blood plasma from recovered patients into treatments for COVID-19. The initial focus will be TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine. But a Takeda spokeswoman told us the idea is to work on all in-progress development efforts. “Companies collaborating as part…

In-house advanced therapy production paves way for smaller facilities, expert

Cell and gene facilities will get smaller according to an expert, who says automation and the vogue for in-house manufacturing will drive the change. Traditional biopharmaceutical manufacturing has relied on processes or platforms that can be used to make a range of products. For example, CHO-based expression systems are used to make many of the best-selling therapeutic proteins. While the specific processes differ for each product, the technologies and methods are common. The platform approach has influenced facility design. Most…