iSpeak Blog

Challenges in Bio Process Validation: Current and Next Generation

Jeffrey Gerstein
Challenges in Bio Process Validation banner - ISPE Pharmaceutical Engineering

In this evolving world of bioproducts and novel manufacturing approaches, consideration for the upcoming challenges in process validation requires innovation and collaboration among our collective industry leaders and our regulatory agencies. The pharmaceutical industry can prepare and incorporate new technology designs to produce quality and safe biopharmaceutical products. The manufacturing of life-saving patient medicines and treatments has required both human and technical elements to support processing in the past.

Pharmaceutical leaders and bio process validation experts are working to build on established methods by eliminating risks, ensuring sterility, and studying product quality at each stage. Currently, the industry is developing techniques that involve a continued verification approach to improve bio process production. Breakthrough treatments such as cell and gene therapy call for redesigned facilities and equipment to accommodate the sensitive or sterile elements in this kind of biomanufacturing. A main challenge for biomanufacturers to encounter is remaining knowledgeable and productive with the increasing approval speed of these brand-new therapies.

The 2019 ISPE Process Validation Workshop will take place 20-21 June in Boston, Massachusetts. This interactive and informative event supports industry professionals facing challenges in process validation by using the lifecycle approach to plan new operations. Bio manufacturers strive for operational excellence, regulatory compliance, and new developments of patient therapies. ISPE’s Process Validation Workshop covers all topics concerning experts in facility design, process validation and manufacturing operations for the future.

The 2019 education agenda features topics centered on product quality, ongoing process validation, and trends in agency regulation. ISPE utilizes resources such as expert perspectives from the FDA and tested methods for the implementation of cutting-edge solutions. The pharmaceutical industry is continuously studying new diagnostic technology for new strategies and operations that will help advance treatments.

By collaborating with experienced educators and young professionals eager to contribute their skills, challenges decrease, and the industry can transform. Attendees can experience seminars covering specific topics across multiple stages of process validation and insight from current regulatory agency representatives including:

  • Presentations on process development and design
  • Process Control Strategies
  • Stage 1 Case Studies
  • PV for Continuous Manufacturing
  • Gene and CAR-T Therapy validation challenges
  • Regulatory trends
  • Emerging Challenges for Stage 2 PPQ

In addition, two workshops will be held where attendee can work with break-out groups and work through further refining issues and improved understanding of potential solutions.

The speakers and presenters at the 2019 ISPE Process Validation Workshop in Boston, include personnel on the forefront of these transformative environments and this is a must attend event for anyone associated with Process Validation in any capacity.

I hope you will be able to attend and help us discuss, analyze, and align our regulatory expectations on these critical topics in our ever-evolving industry. Register now to learn and network with industry, academic researchers and regulatory leaders who are on the forefront of this transformation.

Register Now