CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars

At the end of the three-day course attendees will:

• Gain a solid understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH, WHO) for recombinant proteins, monoclonal antibodies, and biosimilars, and understand why regulatory authorities treat biologics different than chemical drugs
• Have the tools and understanding to develop and carry out an effective CMC regulatory compliance strategy for the company’s protein-based products
• Understand the strengths and limitations of Quality by Design (QbD) – quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs) and justification of the control strategy – and Quality Risk Management (QRM) for biologic manufacturing processes
• Learn how to avoid major delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy 

CMC Regulatory Compliance is Challenging for Biopharmaceuticals

• Discussion of the increasing diversity of recombinant proteins and monoclonal antibodies (including fusion proteins, bispecific antibodies and antibody-drug conjugates) and biosimilars
• Introduction to the regulatory authority systems (FDA, EMA) in place to regulate the evolving biologic manufacturing processes and products: IND → BLA; IMPD → MAA
• CMC regulatory compliance differences between the two U.S. pharmaceutical laws (FD&C Act for chemical drugs and PHS Act for biologics)
• Why biologics are not chemical drugs – the four (4) major differences in CMC regulatory compliance challenges presented by biologics

Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy 

• Three (3) interactive components to protect patients: CMC, GMP and Quality System
• What the ‘minimal CMC regulatory compliance continuum’ means for recombinant proteins and monoclonal antibodies
• Five (5) key design elements of an effective CMC regulatory compliant strategy, including application of Quality by Design (QbD)/Quality Risk Management (QRM) principles
• Importance of identifying product Critical Quality Attributes (CQAs), and then linking them to the identification of the manufacturing process Critical Process Parameters (CPPs) – sooner than later in clinical development – to establish an effective Control Strategy
• Overbearing pressure on the CMC team with Clinical expediting

Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy

• Applied CMC regulatory compliance strategy for recombinant protein and monoclonal antibody (including fusion protein, bispecific antibody and antibody-drug conjugate) manufacturing processes and products
• Raw Materials → Starting Materials → Production → Purification (Drug Substance) → Formulation → Drug Product → Administered Drug Product
• Challenges of genetic instability with cell culture biopharmaceutical production
• Importance, and limitations, of small-scale studies for understanding/validating biologic manufacturing processes
• Increasing control (qualification followed by validation) over the manufacturing process required as clinical development advances
• Identifying of biopharmaceutical product Critical Quality Attributes (CQAs), and then linking them to the identification of the manufacturing process Critical Process Parameters (CPPs), to justify an effective Control Strategy
• Formulation and container-closure challenges for biologics – impact of components on the biologic (e.g., protein aggregation) and impact of the biologic on components (e.g., glass delamination)
• Extra CMC regulatory compliance challenges of Antibody-Drug Conjugates (ADCs) and Combination Products involving biologics

Demonstrating Biopharmaceutical Comparability After Manufacturing Process Changes

• Challenge for biologics of confirming product comparability after manufacturing process changes – utilizing the three (3) risk-based considerations (nature of change, stage of clinical development, and stepwise approach)
• Difference between a comparability exercise and a comparability contract
• Extreme comparability of biosimilars: limitations of CMC comparison, fingerprinting

Critical Need for CMC Strategy Communication with Regulatory Authorities 

• Avoiding critical delays in clinical development (Clinical Holds) or in market approval (Refusal to File or Complete Response Letters) due to an ineffective CMC regulatory compliance strategy
• Requesting CMC-focused meetings with FDA (Type A-C meetings for innovator biopharmaceuticals; BPD 1-4 meetings for biosimilars) and EMA (Scientific Advice)
• Maximizing the value of CMC discussions with the regulatory authorities for your biopharmaceutical – how to word CMC questions to evoke a reactive response from the regulatory authority
• Review regulatory authority procedures/timing for INDs/IMPDs and for BLAs/MAAs
• Locating the FDA and EMA internal CMC review discussions for biopharmaceuticals on their respective websites

“Course was well presented, thorough and precise.  The lecturer was sharp, and his flow was not slow, let us ask any question we wanted during the presentation”

Sephora L., Senior Manager, Reg Affairs CMC, Pharmalex France

"This was an excellent course. Definitely one of the best I have ever attended. The material was useful, presented well and very interesting."

Pascale J., Technical Manager, Genentech

"This course was well structured with a concise slide presentation and case studies."

Ligong W., Downstream Process Development, Thermo Fisher Scientific

"Much, much better than courses I've taken with other providers. The instructor is obviously and expert in his field and has been "in the trenches". The best part of the course was his pragmatic advice based on experience gained over many years of service in many different scenarios."

Stephanie D., Regulatory CMC Scientist, Cook Research

"This is my 2nd course with this instructor. Great course and he is very knowledgeable."

Dr. Pei M., Analytical Dev. QC Mgr, enGene

"This is one of the better courses I've taken. Course content was very relative to my daily job functions. The instructor was extremely knowledgeable and engaging and provided relevant case studies provided in a way that allowed for those with varying technical expertise to understand."

Melanie K., Proposal Manager, Patheon

"Excellent, Top Tier! The course delivered new and useful information and clarified many of the unknown complexities of these CMC topics."

Jim, T., Project Manager, Teva Pharmaceuticals

"Very good course for beginners to Biotech and Biosimilar topics."

Asim A., Manager, Regulatory Affairs, Glenmark Pharmaceuticals

"One of the best I have ever attended."

Emmanuelle V. Quality Product Steward, Bayer

"The course exceeded all my expectations. Great balance between CMC regulatory requirements and the science and hands on experience necessary to establish the implementation plan. The instructor is very knowledgeable and shares his broad experience beyond the book "The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and other Biologics". I am sure this course would be beneficial to anybody working with biopharmaceuticals. I would definitely recommend it and I'll certainly sign up for other CfPIE training courses tailored for the biopharmaceutical sector."

Francisca G., Senior MSAT Specialist, 4 Tune Engineering Ltd.

"This is the most valuable course I have taken in many years. I will be applying what I learned to my current project immediately. The information could not have come at a better time for me. Every section was valuable!"

Duane V., Program Director, Hoffmann-LaRoche

"Great course. Material was well thought out and presented in an efficient and understandable manner. John was a wonderful, knowledgeable proctor. Small classroom format provided ample format for specific questions and individual help."

Seth K., Product Development Scientist, Cook MyoSite

"Course Director is really engaging and knowledgeable. The course provided you with a good overview of the topic for non-specialist"

Francesca Z., Biotech Process Sciences, Merck Serono

"The course was really great, full of valuable information and interesting. The Course Director really keeps attention during whole three days of training. Explanations are clear, interesting, and full of real-life examples publicly available that can be more deeply explored. I reall enjoyed and would recommend to all CMC focused professionals from innovators and generic field."

Suncana B., R&D RA Manager – CMC Documentation, Pliva Croatia Ltd, Member of TEVA Group

The training course was excellent and met all my expectations."

Alexandre S., Director, Silva Regulatory Services Ltda

"Very useful to find a CMC course on biologics that explained the differences from chemical drugs in good detail and had fantastic examples."

Lisa H., CMC Regulatory Director, Hazel CMC Regulatory Solutions Ltd

"I thought the Course Director did an outstanding job of giving a detailed overview of CMC issues. The course was rich with practical information and his examples made the information more interesting. Thanks!"

Dana A., Consultant, The Vaccine Company

"This was the first course that totally deals with all CMC issues from Phase I through to BLA/NDA filing. I would recommend this course to any start-up biotechnology company on how to design your CMC strategy."

Warren D., QA Manager, Progen Industries

"Small classroom format is very beneficial to learning. As a result classroom dynamics were excellent. Participants felt free to ask questions during the presentation and the ensuing discussions were beneficial to all attendees. Also, the course director was approachable and answered each question without dismissing seemingly obvious ones. He understood the diverse disciplines from which the attendees came."

Maureen M., Manager, Regulatory Affairs, Merck Frosst Canada

"The Course Director was excellent and is extremely knowledgeable in regards to CMC for biopharmaceuticals/biologics. He presented various examples from his experience and answered all questions thoroughly."

Nisha P., Associate Manager, QA Compliance, Centocor

"This course provided a thorough broad understanding of the CMC Regulatory process. I would highly recommend this course to any technical person who is involved in preparing CMC documents."

Steven M., Senior Program Manager, Bristol-Myers Squibb

"The organization of the course material gave the proper foundation from topic to topic. Emphasis on critical development issues to avoid delays in the approval of the application were well discussed and rationalized. As someone with no prior Biologics regulatory background I found this a very good introduction to the complexity of the requirements for BLA/NDA submissions."

David L., Director Regulatory Affairs, Forest Laboratories

"Good in-depth course covering all facets of CMC with biopharmaceutical focus - which is hard to find!"

Greg S., QA Manager, GSK

"This course is a precise overview of current CMC regulatory requirements and approaches taken by industry to meet agency regulations. Instructors presentation of the topic under the theme of "CMC continuation" was excellent."

Prakash S., Assoc. Director, Enzon Pharmaceuticals

"Excellent course! Everyone involved in CMC regulatory compliance related matters needs to attend."

Richard S., Group Director – CMC, Hoffman La Roche

"This course was excellent. The amount of information is incredible and the content was laid out very well. Anyone who wants to learn about CMC Regulatory compliance for biopharma & biologics should take this course."

Rodney C., Analytical Validation Specialist, BMS

"The course was very informative and helpful. The only CMC training program I have found that deals with Biologics and Biotech products."

Anne G., CMC Associate, Intrexon

The course covers the Chemistry, Manufacturing & Control (CMC) regulatory compliance requirements and expectations for biopharmaceuticals and biologics in clinical development (i.e., Phase 1 to Phase 3 studies) as well as those having market approval.

The course covers all aspects of CMC regulatory compliance requirements and guidance for biopharmaceuticals and biologics from the FDA, European Medicine Agency (EMA), and International Conference on Harmonisation (ICH).

This course systematically covers all aspects of CMC regulatory compliance concerns, including areas of keen interest to regulatory affairs, manufacturing and development for biologics. On the other hand, the QA/QC Strategy course focuses on all aspects of keen interest to quality assurance and quality control, including control systems and setting of specifications and expiry dating of biologics.