Quality/GMPs

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

Margaret M. Faul is vice-president, Drug Product Technologies, Process Development, Amgen.

Carl L. McMillian is vice-president, Toxicology, Drug Disposition, PK/PD, Eli Lilly and Company.

Pierre Boulas is executive director, Product and Technology Development, Biogen.

Reginaldo A. Saraceno is director, Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals.

Mary Devlin Capizzi is partner, Faegre Drinker Biddle & Reath LLP.

Maureen T. Cruz is senior manager, Science, Regulation and Policy, Faegre Drinker Biddle & Reath LLP.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.  

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Chase Waller works in quality, both at AbbVie Inc.(North Chicago, IL).

Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

Zahid Muhammad works in quality at Merck & Co., Inc. (West Point, PA).

John Bennett works in quality at Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT).

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software. 

Assessing Data Integrity Risks in an R&D Environment 

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19. 

FDA’s “Gold Standard” Critical for Biopharma R&D

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

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

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Proposing a New Method of Detecting Pinholes in Single-Use 

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Technology Innovations Improve Process Chromatography Performance

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

FDA Publishes Guidance on Drug-Drug Interaction Studies for a Therapeutic Protein

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

Drug Safety Summit Discusses Impact of COVID-19 on Pharma Supply Chain 

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Using Process Modeling to Troubleshoot a Bioprocess

Benton Cartledge is associate research scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Jason Carmichael is assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Nathan Haag is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Eric Hansen is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Travis Lato is an assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Predicting Extractables and Leachables from Container Stoppers

Editor of Pharmaceutical Technology Europe

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Regulating Raw Materials Testing

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

Glycoengineering Shows Promise for Enhancing Antibody Therapeutics

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Quality Control/Quality Assurance