The pharma lab in times of cell & gene therapies

PharmaLab will take place in Neuss, Germany, from 21 to 23 November 2022 – firstly with new conference tracks focusing on cell, tissue and gene therapies and secondly with tracks focusing on current developments such as ICH Q14 and ICH Q2(R2) as well as a keynote on the new USP chapter <477> User-Determined Reporting Thresholds (UDRT). The three-day congress will provide important and new information on:

• Optimisation and Automation
• Validation of Analytical Methods and Life Cycle Management of Analytical Procedures
• Alternative and Rapid Microbiological Methods
• Endotoxin and Pyrogen Testing
• Quality Control of Cell- and Gene Therapies/ATMPs

Among others, the following topics will be addressed: On the first conference day, the focus will be set on the:

• revision/development of the ICH Q14 and ICH Q2(R2) guidelines
• quality control of ATMPs
• current rapid methods in microbiology and pyrogen testing – e.g. using MAT.

Some highlights of this day will be:

• ICH Q2(R2)/Q14: Mission accomplished?
• USP <1220> and the Proposed Revision of <1058>
• Alternative Pyrogen Methods: FDA Case Studies
• Next Generation Sequencing: Current Trends and Perspectives for Pharma and Biotech
• Bioactivity Testing for Cell and Gene Therapy Products

The second day will be dedicated to laboratory optimisation and automation, rapid microbiological control of cell and gene therapeutics and the current status of testing for endotoxins using the LAL test or the rFC.

Some highlights of this day will be:

• Qualification of Automated Laboratory Systems including Required Computer System Validation
• Custom Made iPSC-Derived Macrophages as an Efficient Tool for Next Generation Pyrogen Testing
• LER Challenges and Their Solutions – A Case Study
• Viral Safety – Evaluation of Eukaryotic Cell Bank Purity with a Special Focus on Adventitious Agents and Replication Competent Viruses
• Short Shelf Life and Sterility Testing – Challenges of Cell Based ATMP Market Supply

As in 2018 and 2019, the Pre-Conference Workshop on 21 November will focus on current trends in mycoplasma detection. Among others, the following topics will be discussed:

• Recent revision proposal of Ph. Eur. chapter 2.6.7 “Mycoplasmas”: What is proposed to be changed and why?
• Pitfalls and Issues on Mycoplasma Testing According to Pharmacopoeial Requirements
• A Regulator’s View on ATMPs
• Validation of DNA Extraction Robots – The Balance between GMP Annex 11 v. Actual Best Performance
• Alternative Adventitious Agents Detection Methods in Biopharmaceuticals: A Proposal for a Structured Best Practice Approach for their Evaluation, Validation and Implementation

With more than 90 speakers and more than 90 presentations, Pharmalab appropriately offers a unique opportunity to familiarise oneself with the current state of regulations, science and tech­nology.

This article was originally published in European Biotechnology Magazine Autumn Edition 2022.