Pharma giant AstraZeneca has submitted data to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its antibody duo AZD7442.
Medicines for rare and paediatric diseases have been successfully enabled through the EU’s incentives framework. The number of medicines in development has risen significantly since the introduction of the legislation (3,678 applications for orphan designation by end 2020).
Cell and Gene Therapy Processing?Personalised tumour treatments are expensive. This particularly applies to individual cancer therapies based on gene-modified T cells. Currently, they are produced manually or, at best, in a partially-automated process. In a collaboration project ProCell for Patient, two hospitals are currently working with Optima Pharma to develop an automated unit for the decentralised production of a CAR-T cell product in treatment centres.
Richter-Helm is a leading and expanding Germany-based contract development and manufacturing organization (CDMO). Richter-Helm provides excellent services in the continuously growing market of pharmaceutical biotechnology. Offering a broad range of microbial manufacturing, development and analytical services, Richter-Helm will bring customer projects to the next level.
Lengnau will become the newest site in Thermo Fisher Scientifics biologics manufacturing network. The site is to be completed in 2022 and its staff of 200 will join the company.
The success of any adoptive cell therapy lies in how effectively and selectively engineered immune cells interact and kill cancer cells. Functional phenomics enables insights that can dramatically accelerate the development of next-gen cell therapies. evorion biotechnologies brings functional phenomics to pharma and biotech partners via exclusive access to a unique, proprietary pipeline for in-depth multi-modal analysis of thousands of cell-cell interactions at single-cell resolution.
BionTech SE, which has been very successful in the field of corona vaccines, is starting phase II tests with its colorectal cancer candidate BNT122.
This whitepaper provides insights into why it is critical to manage, optimize and streamline a supply chain to mitigate risks, such as those brought on by the COVID-19 pandemic.
Small-volume biopharmaceutical processes continue to grow as more biopharmaceutical, cell therapy and gene therapy companies develop products. A 2021 Association for Regenerative Medicine (ARM) report states that there are 1,085 cell, gene and tissue-based therapy developers worldwide. These companies are engaged in many small-volume (<10L) processes including early-stage drug development and autologous therapies.