Author Archives: Anna Brown

Voices of Biotech: Lets talk women’s well-being

by

The co-CEO’s of the FemTech Association Asia discuss democratizing women’s health and the investment opportunities in Asia.    The latest episode of Voices of Biotech, produced by the Bioprocess Insider Expression Platform, brings you a conversation between the two co-CEO’s of the FemTech Association of Asia. This initiative was founded by Lindsay Davis, co-CEO, in 2021 and is Asia’s first and largest network for organizations and investors in FemTech. The association has over 135 members and 60 start-ups, across nine countries in Asia. Davis…

August 21, 2023

FDA draft guidance aims to improve CGT manufacturing

by

The US Food and Drug Administration (FDA) has published its draft recommendations for managing cell and gene therapy (CGT) manufacturing changes. The new draft recommendations outline actions for sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products. The draft guidance covers the FDA’s thinking on the management of manufacturing changes for CGT products and compatibility studies to assess final product quality. This advice will “improve product quality, expand product supply, or improve…

July 19, 2023

Mentorship key to embedding DE&I into company culture, CGT expert

by

“We want to see women ascending leadership positions and that will be our metric of success,” says Lara Silverman, principal consultant at LIS BioConsulting on the latest Voices of Biotech podcast. In the latest Voices of Biotech podcast, brought to you by the BioProcess Insider Expression Platform, Lara Silverman sheds some light on career paths, mentorship, and taking ownership of your own development. Silverman discusses DE&I in the cell and gene therapy space, emphasising the goal is to get to…

June 14, 2023

Bayer licenses lipid nanoparticle tech for gene therapy

by

Bayer has licensed lipid nanoparticle (LNP) technology from Acuitas Therapeutics to develop in vivo gene editing and protein replacement programs in the liver. Bayer has joined forces with Acuitas Therapeutics, a Canadian biotechnology company specializing in LNP delivery of nucleic acid therapeutics. The partnership grants Bayer, and its affiliate Asklepios BioPharmaceutical (AskBio), access to Acuitas’ LNP technology. Bayer and AskBio will provide the gene editing technologies. “The collaboration will focus on developing and enabling in vivo genome editing CRISPR therapies for…

June 7, 2023

WHO-backed mRNA tech transfer platform looks beyond COVID, says MPP

by

Medicines Patent Pool (MPP) says its collaboration with the WHO helps to empower lower- and middle-income countries (LMIC) to manufacture vaccines and therapies locally. In 2021 the mRNA technology platform was founded by the World Health Organization (WHO) and Medicines Patent Pool (MPP) – a global health advocacy group funded by the multi-government initiative Unitaid. The collaboration, announced in response to the inequality in access to healthcare highlighted by the COVID-19 pandemic, aims to increase health security in LMICs, helping…

May 15, 2023

Expert: Synthetic promoters for transcription the ‘foundation of modern biotech’

by

Synthetic biology could be used to develop a new paradigm in controlling cellular function and specificity, according to a bioprocess engineer at BPI Europe.   Speaking at the event in Amsterdam, The Netherlands this week, David James, professor of bioprocess engineering at the University of Sheffield, told delegates the manufacturability of biotherapeutics can be enhanced by synthetic biology through the design of specific genetic systems. Chinese hamster ovary (CHO) cells are a workhorse in biomanufacturing, used to produce large quantities of…

May 12, 2023

Plasticell and LambdaGen team on off-the-shelf stem cell platform

by

The $650,000 partnership hopes to reduce manufacturing cost and increase immunoactivity for iPSC-derived allogenic cancer immunotherapies. The strategic partnership between UK-based Plasticell and Singapore-based LambdaGen will develop induced pluripotent stem cell (iPSCs) derived chimeric antigen receptor-natural killer (CAR-NK) allogenic cancer immunotherapies. The collaboration is funded by EUREKA GlobalStars, an international research and development funding program. LambdaGen will be responsible for generating the iPSC lines engineered with CARs that enhance the anti-tumor activity of the body’s immune cells. Plasticell will use…

April 28, 2023

Ghanaian consortium to build manufacturing plant

by

President Nana Addo Dankwa Afkufo-Addo has announced the construction of Ghana’s first vaccine manufacturing facility.   Ghana is set to begin construction of its first manufacturing plant this July, with the expectation to be fully operational by January 2024. Under DEKs Vaccine Ltd, a private sector-led consortium of local Ghanaian pharmaceutical firms, the facility will be a fill/finish site, responsible for producing vaccines for rotavirus, cholera, malaria, and pneumonia. It will primarily manufacture malaria vaccines and import COVID components to…

April 26, 2023

Pfizer touts mRNA as alternative to current flu vaccines

by

Pfizer says its mRNA-based influenza program, in collaboration with BioNTech, has potential to succeed current vaccination technologies. With influenza causing 650,000 global deaths every year, developing a more flexible and accurate vaccine is in the interest of global health. Last September, Pfizer initiated a Phase III study of its messenger RNA (mRNA) based flu vaccine, following a 2018 partnership with a then little-know German biotech BioNTech. In 2020, both BioNTech and mRNA were thrown into the global spotlight due a…

April 20, 2023

Biogen licenses Denali’s ATV platform for Alzheimer’s candidate

by

Biogen will develop and commercialise an Alzheimer’s candidate using Denali’s Antibody Transport Vehicle (ATV). Following the original $1 billion deal forged in 2020, Biogen has licensed Denali’s Antibody Transport Vehicle (ATV) Amyloid beta (ATV:Aβ) program through an additional upfront exercise payment, granting Biogen access to Denali’s technology to treat Alzheimer’s disease. Biogen has not disclosed the licensing cost, but Denali has potential to receive additional development and commercial payments, dependent on future sales. Biogen will be responsible for developing and…

April 17, 2023