Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Insights into molecular behaviors and predictive capabilities are bringing numerous benefits.

Molecular Modeling in Formulation Development

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

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

Videos

Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Converting to Continuous Manufacturing with CONTINUUS Pharmaceuticals at CPHI Barcelona

Dr. Nikunj Patel is a senior director of PBPK Consultancy Services in the Simcyp division of Certara. Nikunj helps clients with advanced PBPK modeling to expedite internal decision making, support biowaivers via virtual bioequivalence assessments, and develop model-informed regulatory strategies for novel products, generic formulations, scale-up and post-approval changes (SUPAC), and justification of dissolution specifications. He has more than more 13 years’ experience in computer-aided drug design and PKPD modeling, including 10+ years’ experience focusing on PBPK modeling.

Ellen Leinfuss is senior vice president and chief commercial officer for Certara’s Simcyp Division. Simcyp is the global leader in mechanistic modeling, employing its Simcyp Simulator physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) immunogenicity, immuno-oncology, vaccine, and gene therapy modeling and simulation platforms. Ellen has worked for Certara for eight years, serving for several years as chief marketing officer for the corporation. She has a BA in chemistry and an MBA in marketing.

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

Advancing Oral Drug Development Using MIFD

Jennifer Markarian is a contributing editor for 

Machine learning provides real-time data for process control of high-shear wet granulation.

AI Algorithms Find Use in Pharma Equipment

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing. 

Envisioning Digital Pharma Manufacturing

Decreasing vein to vein time saves lives.

High-titre Vector Producing Cells

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

Building Up to a Bright Future

Meg Rivers is the former senior editor for 

Podcasts

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

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.