Development

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.

Articles

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

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

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.

Process Validation Sets the Stage for Ongoing Manufacturing Quality

Makoto Sadamitsu is a principal scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Shunsuke Omori is scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Ohta is a principal scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Click here to view a PDF of this article.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. 

Continued Process Verification and the Drive to Digitize the Process Validation Lifecycle

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.