Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges

Introductory Module 1

FREE to Attend | Live & Recorded

Introduction to CMC analytics for biologic, cell & gene, vaccine and biosimilar products

• Introduction to CMC analytics
• Overview of the challenges during development and manufacturing
• Highlight important guidelines you should be aware of

Day 1

DD MMM 2023 | Session 1 |  120 mins | 13:00 PM UK

Current CMC regulatory requirements and hot-button issues for biological and cell & gene products

• Why do biological product CMC requirements differ from those of chemical products?
• Why are there different safety concerns about biological product and process related impurities?
• Which specific worldwide regulations detail CMC study requirements for biological and cell & gene products?
• What are the relevant ICH Guidelines such as ICH Q5A, ICH Q5B, ICH Q5C, ICH Q5D, ICH Q5E, ICH Q6B.
• What CMC analytical data packages are required for regulatory approval of all biological and cell & gene products?
• When should these CMC studies be done during the product development lifecycle?
• How are these CMC studies impacted by accelerated clinical programs?
• Which of these CMC data are generated in GMP vs R&D labs?
• What is the risk of CMC data generated by non-GMP AD/PD R&D labs?
• What are commonly implemented quality practices for CMC AD/PD R&D labs?
  

DD MMM 2023 | Session 2 |  120 mins | 3:15 PM UK

Phase-appropriate analytical method lifecycle expectations for biological and cell & gene products

• What is the difference between method qualification and method validation?
• When is a method qualification acceptable, and when is a method validation necessary?
• What is required for the verification of compendial methods?
• What are the most important elements a correct method qualification/ verification/validation study?
• Which method validation parameters are usually designed incorrectly for biological and cell & gene products?
• What are the requirements when making changes in analytical methods at any phase?
• What are the key elements of method tech transfer studies (changing from lab A to lab B)?
• What are the key elements of method bridging studies (changing from method A to method B)?
• How are changes staged for methods being used in stability protocols?
• What are key considerations when using contract testing laboratories for analytical methods?

Day 2

DD MMM 2023 | Session 1 |  120 mins | 13:00 PM UK

Specifications, reference standards, and critical assay reagents

• What are the key characteristics of any biological and cell & gene products that require control and consistency?
• Where can you find the analytical methods currently being used for various biological and cell & gene products?
• What four critical elements are needed for the establishment of meaningful, reliable specifications?
• What are some of the types and uses of biological reference standards and materials?
• What is the tiered approach to biological product reference standards?
• What are the critical elements of bridging biotech physiochemical vs potency reference standards?
• What are the current expectations for characterisation, comparability, and control of HCPs?
• Which process impurity reference standards are required for recombinantly-expressed products?
• How should critical reagents/materials be managed to better assure consistent method performance?

DD MMM 2023 | Session 2 | 120 mins | 13:00 PM UK

Phase-appropriate stability and comparability requirements for biological and cell & gene products

• What are the phase-specific requirements for biological and cell & gene product stability studies?
• How is the stability-indicating profile of a biotech product experimentally established?
• What data are required in the validation of stability-indicating methods?
• Why are stability data the main indicator of performance variability in validated methods?
• What are the critical logistical elements of a stability protocol at any phase of development?
• What are target, accelerated, stressed and forced conditions for biological and cell & gene products?
• Why can’t biological and cell & gene product shelf life be extrapolated from accelerated stability data?
• What is the core paradigm to follow when making changes to biological processes?
• What is the tiered approach to comparability studies for biological products?
• What are the important procedural elements of an analytical comparability study?
• How do comparability studies change relative to the phase of product development?

Nadine Ritter – CMC, Analytical Expert – Biologics & Advanced Therapies

 

Nadine M. Ritter, Ph.D., obtained her master’s and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years.

 

Dr. Ritter entered the biopharma industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer, and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for in vitro diagnostic product submissions, responded to FDA comments, contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of an R&D analytical lab.

 

Dr. Ritter then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements.

 

In 1999, she created the first public training class specifically focused on biological product stability programs, which later grew into an award-winning CMC analytical training course. She conducts in-depth training workshops on all aspects of CMC analytics for biologically-derived products, updating class materials and reference documents each month.

 

Since 2002, Dr. Ritter has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA).

 

In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. Through Global Biotech Experts, she can bring in affiliate support from elite consulting colleagues with extensive experience in process development and validation, manufacturing facility PAI and GMP inspections, and technical writing for R&D and GMP applications.

Throughout her career, Dr. Ritter has contributed to the success of over 120 international IND/IMPD and BLA/MAA filings and Post-Approval Change Protocols. She has engaged in numerous PAI readiness audits and due diligence inspections and has remediated analytical, regulatory and laboratory compliance problems around the world. She is on the CMC scientific advisory boards of several international biopharmaceutical companies.