Development

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

Articles

The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. 

Single-Use Technologies Prove Effective for Viral Vector Process Development

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals.

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals.

Robert Rhoades is managing partner at Validant.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

Assessing Manufacturing Process Robustness

Agnes Shanley is senior editor of Pharmaceutical Technology.

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control. 

Getting More Scientific About Cleaning Validation

Francesca Speroni is project leader at PTM Consulting and is a member of the AFI process validation working group.

Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco and is a member of the AFI process validation working group.

Maurizio Valleri is in Pharmaceutical Technology at Menarini and is a member of the AFI process validation working group.

Mauro Silvestri is in Manufacturing Technology at Angelini and is a member of the AFI process validation working group.

Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing and is a member of the AFI process validation working group.

in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Alessia Garavaglia is in Good Engineering Practices at Grünenthal and is a member of the AFI process validation working group.

 at Mipharm and is a member of the AFI process validation working group.

Rosa Terribile is in QA at Mipharm and she is a member of the AFI process validation working group.

Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific and is a member of the AFI process validation working group.

Enrico Modena is in R&D at PolyCrystalLine and is a member of the AFI process validation working group.

Stefano Selva is in Pharmaceutical Technology at Recordati and is a member of the AFI process validation working group.

Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche and is a member of the AFI process validation working group.

Cesare Armetti is an AFI member and participates in the AFI process validation working group.

 is an AFI member and participates in the AFI process validation working group.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Ensuring Smooth Tech Transfer of Bioprocess Operations

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Mapping a Route for Cell and Gene Therapy Process Development

Getting the science right helps biopharma startups overcome development and commercialization challenges.

Science Focus Fuels Successful Process Development for Startups

Clifford J. Sachs is managing consultant, Tunnell Life Sciences Consulting.

A properly designed validation program will detect variation and ensure control based on process risk.