Development

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Which Batch Size for Validation and Stability Studies?

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

Steven J. Lynn is executive vice-president, pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Verifying Compendial Methods

Toni Manzano, toni.manzano@aizon.ai, is chief science officer and co-founder at Aizon.

Qualified algorithms enable validation of machine learning models that can be used for process optimization. 

Qualifying AI Algorithms in Pharmaceutical Manufacturing

Genezen has opened its new process development and analytical lab for viral vector production.

Genezen Starts Up Operations at Lenti- and Retroviral Vector Process Development Lab

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

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.