The evolution of therapeutic modalities drives the adoption of single-use technologies.

Review of SUT Adoption in Biopharma Manufacturing

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

 Automating the Future of Fill/Finish

Topic

Articles

Bio-Rad Laboratories’ Pioneer Antibody Discovery Platform is an antibody discovery service specifically designed to develop best-in-class biologic candidates.

Biologics-Oriented Antibody Discovery Platform

Webcasts

Webinar Date/Time: Thursday January 19, 2023 at 11am EST | 10am CST | 8am PST


FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Consent Decree Against Oklahoma Drug Compounder Enters Federal Court

Meg Rivers is the former senior editor for 

Podcasts

In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Henderson, key account manager of Vetter.

Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 2

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care. 

Nurturing Manufacturing Agility

Emmes’ new facility is designed to support clients conducting cell and gene therapy research worldwide. 

Emmes Launches Cell and Gene Therapy Center

Thermo Fisher Scientific’s new facility in Hangzhou, China, is designed to boost biologics and sterile development and manufacturing capabilities in the Asia-Pacific region.

Thermo Fisher Expands Biologics and Steriles Manufacturing Capabilities in China

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 

The R&D analytical solutions will consist of analytical lab services that use USP’s in-house scientific expertise and state-of-the-art facilities at the USP Advanced Manufacturing Technology Lab in Richmond and the USP headquarters facility in Rockville, Md.

USP Advanced Manufacturing Technology Lab Opens for Further Developments in R&D Analytics

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.