Development

Dijana Hadziselimovic is laboratory manager, Technical Services, at STERIS, Saint Louis, Mo.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Articles

This article explores a grouping strategy for therapeutic peptides incorporating theoretical and experimental methodology and results to define a practical and scientifically justified cleaning procedure.

Cleaning Process Design for Peptide Therapeutics

The agency has published final guidance documents regarding validation and development of analytical procedures.

FDA Releases Guidance on Analytical Procedures

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

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Videos

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality and other highlights from his part of the session, "Process Validation for CAR-T Products: A Continuous Journey."

Highlighting CAR-T as an Important Modality (PDA/FDA Joint Regulatory Conference 2023)

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)

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

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

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

Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.

Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.


Evolution of Analytical Procedure Validation Concepts: Part II

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.


Evolution of Analytical Procedure Validation Concepts: Part I

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

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?

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.