Development

Claudia Berdugo-Davis, PhD, is director of Process Development, Catalent Biologics.

Danielle Wittenwyler, PhD, is manager, Manufacturing Science & Technology, Catalent Biologics.

Articles

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Streamlining and Standardizing Process Characterization

Chris Spivey is the editorial director of 

Lives are saved when time from vein to vein decreases.

Therapeutic Biologics and the Need for Speed

Decreasing vein to vein time saves lives.

High-titer Vector Producing Cells

Bojiao Yin is director of Vector Process Development at ElevateBio.

Mercedes Segura Gally is vice-president of Vector Process Development at ElevateBio. 

Jimmy Xin is scientist at Vector Process Development, ElevateBio. 

 is scientist at Vector Process Development, ElevateBio.

There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.

Tactics and Strategies for Designing an Ideal Lentiviral Vector Platform

Rozaleen Dash is a post-doctoral fellow in the Department of Chemical Engineering at the Indian Institute of Technology (Delhi). 

 was a research associate at the DBT Centre of Excellence for Biopharmaceutical Technology at the Indian Institute of Technology under the guidance of Professor Anurag S. Rathore, Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

A novel mathematical approach for fitting concentration-response curves is proposed that offers a more accurate estimation of potency data.

Mathematical Modeling of Cell-based Potency Data for mAb Biotherapeutics

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

Process Development and Control for New Modalities

Feliza Mirasol is the science editor for 

A simplified downstream process can save time and costs but requires enabling technologies.

Considerations for Simplifying Downstream Processes

Meg Rivers is the former senior editor for 

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Deciding Where to Outsource in Biopharma Development and Manufacturing

Mili Pathak is principal scientist, Process Science, R&D, at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Prashant Pokhriyal is associate scientist at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Ronak Patel is principal scientist, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

Laxmi Adhikary, PhD, is senior vice-president, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

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