Global Markets

Commercial CAR-Ts: Ensuring lentivirus supply key for J&J and BMS

J&J and Bristol-Myers Squibb have spoken of plans to increase supply of lentivirus as they continue to roll out their respective CAR-T therapies. Bristol-Myers Squibb, meanwhile, achieved commercial chimeric antigen receptor T-cell (CAR-T) success in early 2021 with the approval of both Breyanzi (liso-cel) – which last week was granted second-line approval for relapsed or refractory large B-cell lymphoma (LBCL) by the US Food and Drug Administration (FDA) – and Abecma (ide-cel) for multiple Myeloma. In March 2022, the FDA…

invoX acquires bispecific firm F-Star for $161m

invoX Pharma, a Sino Biopharm subsidiary, will pay $161 million to acquire F-Star, a Cambridge, UK clinical stage company developing bispecific drugs for immunotherapies. F-star’s platform technology pioneers the use of tetravalent (2+2) bispecific antibodies. These antibodies target two different antigens and are paired with a unique set of pharmacology agents to activate an immune reaction in the tumor microenvironment. F-Star has four candidates in clinical trials, three from its tetravalent platform and one next-gen STING agonist. invoX, located in…

From UK to Rwanda: mRNA driving localized manufacturing model

Moderna is bringing local mRNA manufacturing to the UK through a large-scale facility, while BioNTech has broken ground on a modular scalable mRNA plant in Kigali, Rwanda. Is this the start of a localized production trend? BioNTech this morning announced its efforts to bring localized vaccine manufacturing to Africa have reached a milestone with the commencement of construction of a manufacturing facility in Kigali, Rwanda expected to produce around 50 million doses of mRNA vaccine. The news comes eight months…

Sandoz roadmap aims to up biosimilar use 30% by 2030

The 12 goals within Sandoz’ Act4Biosimilars initiative hope to increase the global adoption of biosimilars by at least 30% in over 30 countries by 2030. Novartis’s Sandoz division is a pioneer in the biosimilars space, being the first company to receive approval of a biosimilar in the US through Zarxio, a version of Amgen’s Neupogen(filgrastim), in 2015. It has also been an advocate of these medicines, which have the potential to reduce the cost of medicine for patients and payors.…

Gilead: CAR-T still in infancy but the future is both auto and allo

Investment and innovation will continue to pour into autologous CAR-T therapies even as allogeneic products begin to impact the market, according to Gilead Sciences. Gilead Sciences is a pioneer in the cell therapy space, acquiring Kite Pharma in 2017 months ahead of the FDA approving Yescarta (axicabtagene ciloleucel), the second CAR-T therapy to achieve commercial success. Gilead won approval for a second autologous CAR-T, Tecartus (brexucabtagene autoleucel), in July 2020. Talking at the Bernstein Annual Strategic Decisions Conference last week,…

CEPI’s 100-day vaccine mission takes aim at future pandemics

Every single step of the vaccine process needs shortening says CEPI, which is developing a strategy to produce safe and effective vaccines against future threats in just 100 days. Face-to-face events are well underway, and BioProcess Insider headed to BPI Europe in Vienna, Austria where Anna Särnefält, CMC lead at the Coalition for Epidemic Preparedness Innovations (CEPI), said the key to responding to epidemics and pandemics is preparedness. The 100 Days Mission is a project that aims to  produce safe…

Bavarian Nordic to respond to monkeypox threat with vaccine supply

Bavarian Nordic will supply its smallpox vaccine Imvanex to at least two countries as cases of monkeypox surge in Europe and elsewhere. The surge of cases of monkeypox outside west and central Africa have alarmed health authorities over the past few weeks. While some commentators claim the outbreak is nothing to be too concerned about, some governments have looked to secure vaccinations in order to mitigate against a potential epidemic. There is no official vaccine for monkeypox in Europe, but…

Podcast: Opening the gates for women in biotech

There is no lack of talented women in the biotech space but the gates blocking their progression must be open for them to fully realize their potential, says consultant Nadine Ritter. Companies’ Diversity, Equality, and Inclusion (DEI) policies are too often just an exercise in box-checking, said Nadine Ritter, president and analytical advisor at Global Biotech Experts and long-time member of BioProcess International’s editorial board. “If it’s just virtual signaling on a website then I don’t care… show me the…

Keeping supply chains resilient in times of crisis

Robust risk management can offset supply chain problems that have been further aggravated by COVID-19, says Samsung Bioepis’ Thomas Newcomer. Since the start of the COVID-19 pandemic, the pharmaceutical industry has experienced many unprecedented situations. Disruptions to drug supply chains has become a primary concern across various markets. As much of the industry’s resources has been invested in pandemic response, the pharmaceutical industry has experienced an increase in supply chain or regulatory bottlenecks and in some cases drug shortages. This…

JSR launches services firm for biosimilar development

Newly formed business division Similis Bio will help companies improve efficiency and cost of biosimilar development, says JSR Life Sciences. According to JSR, Similis will provide biosimilar drug developers with solutions to drive development timelines and decrease associated costs. Additionally, Similis will supply partners with data to establish a biosimilar target as well as offering complete analytical and process development packages. The data packages include analytical procedures, product data, process knowledge, and CMC templates from a centralized model created to…