Boosting Drug Development
New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?
Platform-Specific Risk Assessment of SARS-CoV-2 Vaccines Using FMEA
Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.
Exploring the Therapeutic Value of Blood Components
Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
A Unified Approach for Scaling Bioprocess Unit Operations
A unified scale-up approach, as presented here, can be applied to any unit operation.
Meeting Fill/Finish Challenges for COVID-19 Vaccines
CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.
Conducting Effective Audits During and Post Pandemic
With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.
FDA Inspection Shutdown Increasingly Delays Approvals
FDA puts applications on hold as the agency limits alternative oversight methods.
How Pharmaceutical Innovation is Saving the World
Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.
A Hopeful but Dangerous Phase
A complicated vaccination rollout and mixed messages may derail the pandemic endgame
