Home > Resources > Whitepapers > Early engagement and regulatory considerations for biotech

Industrial Impact

Early engagement and regulatory considerations for biotech

March 24, 2023

Biotechnology companies are at the epicenter
of innovative drug development, with discoveries
spanning from small molecules, large molecules,
and biologics to genomic medicines and first-inclass immunotherapies.

Spotlight

MaSTherCell

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market.

OTHER WHITEPAPERS

Growing a circular economy with fungal biotechnology

whitePaper | August 17, 2022

Fungi have the ability to transform organic materials into a rich and diverse set of useful products and provide distinct opportunities for tackling the urgent challenges before all humans.

Automated Extraction of High Molecular Weight DNA

whitePaper | November 14, 2019

SmartExtraction significantly simplifies the entire automated workflow of DNA extraction, setting new standards with regard to efficiency, yield and quality of the DNA.

Are Nitrosamines a Concern for Biologic Manufacturers?

whitePaper | March 30, 2023

The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered atrisk.

Quality Control Solutions for Cell and Gene Therapy

whitePaper | September 10, 2022

Droplet Digital PCR (ddPCR) provides highly precise and absolute quantification of nucleic acids by counting nucleic acid molecules encapsulated in discrete water-in-oil droplets.

U.S. NATIONAL SCIENCE FOUNDATION

whitePaper | August 21, 2022

The “Government Performance and Results Act” and the “GPRA Modernization Act of 2010 require federal agencies to develop strategic plans setting forth long-term goals and objectives. Guidance.

Producing therapeutic peptides using biotechnology

whitePaper | October 20, 2022

We began the project by working to the design of a recombinant bacterial strain selection of a strain capable of producing high concentrations of peptides.