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

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

Articles

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.

The most safe and effective therapies demand the highest data quality. 

Driving Data Quality and Ensuring Compliance Using Modern CDS Solutions 

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabas Solutions LLC, who ran the overseas QMM pilot project.

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

Advances in contamination control are being to mitigate the presence of pollutants in drug products.

Examining Contamination Control

Wai-Chi Man is IC/SP product marketing manager at Thermo Fisher Scientific.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.



Automating Glycoprotein Analysis for Vaccine Manufacture

Kenji Tabata, PhD, is senior vice-president, head of Discovery Intelligence, Applied Research & Operations, at Japan-based pharmaceutical company Astellas.

Advancing digital transformation can significantly reduce R&D costs and shorten drug discovery timelines.