Biologics have transformed the healthcare industry, offering innovative solutions through monoclonal antibodies, vaccines, and recombinant proteins. But the road to producing these therapies is not without its complexities.
We spoke with Laura Jeannel, the expert behind CfPA’s “cGMPs for Biologics” course, to better understand the importance of mastering biologics manufacturing standards. Ms. Jeannel addresses the critical components that this course covers, revealing its importance in influencing the future of biologics, healthcare, and the careers of pharmaceutical and biotechnology experts.
Cobblestone: Why is it essential for professionals in the pharmaceutical and biotechnology industries to undertake a dedicated course on cGMPs for Biologics?
Laura Jeannel: This course is important because it is specifically designed to address the unique challenges that biologics in the pharmaceutical and biotechnology industries face. Biologics, which encompass products like monoclonal antibodies, vaccines, and recombinant proteins derived from biological sources, require stringent manufacturing standards to ensure their safety, efficacy, and consistency. This course provides professionals with the specialized knowledge and expertise necessary to excel in this field, making it an indispensable resource for their careers.
Cobblestone: What can participants expect to learn from this course?
Laura Jeannel: Participants will gain a comprehensive understanding of GMP fundamentals and advanced topics, covering areas such as manufacturing, facility design and controls, and quality management systems. They’ll also learn how to ensure the consistency and safety of biologic products, explore process validation, and understand strategies for managing FDA and EU Regulatory Inspections for complex products effectively.
Cobblestone: Could you elaborate on the key learning objectives of this course?
Laura Jeannel: Certainly. The course covers several essential learning objectives. Participants will learn the key principles of biologics and biopharmaceuticals, gain knowledge of FDA/EU quality and regulatory expectations, and explore the history of biologics and industry advancements. They’ll also focus on areas such as CMC/Manufacturing, Quality Assurance, Quality Control, Supply Chain, Facilities, and Regulatory submissions for a phase-based approach and novel technologies.
Cobblestone: How does this course help individuals navigate the complexities of biologics and biopharmaceuticals?
Laura Jeannel: This course provides pragmatic lessons learned and insights into the latest technologies and processes within the biologics field. It also equips participants with the skills to streamline and enhance Quality Management Systems. By completing this course, individuals will be well-prepared to handle the unique requirements of the FDA and EU GMP regulations as they pertain to biologics manufacturing.
Cobblestone: Why is understanding FDA and EU GMP requirements so crucial in the context of biologics manufacturing?
Laura Jeannel: FDA and EU GMP requirements are critical because they ensure that biologic therapies are produced to the highest safety and efficacy standards. By comprehending and adhering to these regulations, professionals in the biologics industry contribute to advancements in healthcare and improved patient well-being. This knowledge is essential for anyone involved in the production of safe and effective biologic therapies.
Coblestone: What can participants look forward to in terms of attending the course?
Laura Jeannel: This course offers a well-rounded learning experience, including case examples, Q&A sessions, and dedicated discussion forums. We’ve designed it to be interactive and engaging, ensuring that participants can ask questions and engage in practical discussions.
Cobblestone: How does this course address the latest trends and advancements in the biotech industry?
Laura Jeannel: We aim to keep our course content up-to-date by incorporating the latest trends and advancements in the biotech industry. This ensures that participants are well-informed about the digitalization of the biotech sector and the evolving landscape of biologic therapies. Our goal is to empower professionals with the knowledge they need to thrive in this dynamic field.
Cobblestone: Thank you, Laura, for your time.
In this insightful Q&A interview with course instructor Laura Jeannel, we’ve gained a deeper understanding of the vital role this course plays in the pharmaceutical and biotechnology industries. With its specialized focus on biologics, this course equips professionals with the knowledge and expertise needed to ensure the safety, efficacy, and consistency of these cutting-edge therapies. It’s clear that staying updated with the latest regulations and advancements in this dynamic field is essential for anyone involved in producing safe and effective biologic therapies, contributing to the betterment of healthcare and patient well-being.
Click here to learn more about our accredited 8-hour course on “cGMPs for Biologics.”.
Laura Jeannel is a Senior Quality Consultant for Farbridge Pharma Consulting, and an experienced Quality Assurance professional with over 20 years’ experience. During her career, she has led major pharmaceutical companies in establishing, executing and continuous improvement for sustainable Quality Management Systems. Ms. Jeannel has been responsible for the launch of multiple complex projects in pharmaceuticals, biologics, cell and gene therapy and medical devices. She is a recognized trainer for key Quality Systems and pragmatic solutions for building positive partnerships for continuous improvement.
