Drug Development

Articles

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

The Punctuated  Evolution of Computer Software Validation

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Shiri Hechter is senior lab operations manager for Nelson Laboratories

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Considerations for Method Validation

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Dissolution testing is experiencing a refresh thanks to a variety of market drivers.

Building Up to a Bright Future

Doris Rottenbusch is the team manager for technology and process transfer at Vetter Pharma Fertigung GmbH & Co KG.

Adherence to detail and thorough project management are required for successful tech transfer and scale up.

Scale-up and Tech Transfer: From Development Lab Studies to Commercial Production

Podcasts

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Drug Solutions Podcast: Novel Excipients in Drug Development

Meg Rivers is the former senior editor for 

An expert from Aptamer Group reveals the potential of Optimers (a type of aptamer) in the realm of drug delivery, including its targeting capabilities, scalability, and key differences between Optimers and antibody-drug conjugates. 

Drug Solutions Podcast: Drug Delivery Systems: Optimer’s Therapeutic Targeting and Scaling Capabilities vs. ADCs

Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point. 

Drug Solutions Podcast: Cell Therapy Development: Advances, Trends, and the Challenge of Retention

Feliza Mirasol is the science editor for 

Videos

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

Drug Digest: Development and Scalability of ADCs and CGTs

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

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Process Development Struggles with Molecular Diversity

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Process and Scaling