Manufacturing metric tons of HPAPIs: what does success look like?

Overview

Moving from lab to large scale builds upon all the competencies required for handling HPAPIs. Particular attention must be paid to safe handling, containment systems, to protect workers from exposure and cross-contamination prevention.

In the third webinar of our series, we invite you to take a closer look at Evonik’s large-scale production site in Lafayette, Indiana located in the U.S. Your guides Ben Larson, Theresa Ledbetter, and Robert Farner will talk you through the many considerations needed to handle a multi-ton HPAPI production. You will get insights into challenges and lessons learned which have helped build a successful HPAPI CDMO business.

This webinar is suitable for anyone in external manufacturing outsourcing, procurement, engineering, EHS, industrial hygiene, quality assurance, or project management, who is interested in learning more about large scale HPAPI manufacturing.

Key learnings for participants of this webinar:

The hidden risks of handling HPAPIs – items that may be overlooked or misunderstood
Tips and tricks for successful highly potent API manufacturing
Real-life examples, photos and case studies

Experts featuring this session

Theresa Ledbetter
Director of Key Account Management and Sales
Evonik Health Care
Vita

Theresa Ledbetter has worked for Evonik for more than 15 years in production, supply chain, and business development roles. She is currently the Director of Key Account Management and Sales for Evonik Health Care.

Theresa has a background in chemical and pharmaceutical engineering from the University of Michigan, and throughout her career she has supported the successful technical transfer and scale up of more than 20 commercial GMP processes, ranging from pilot to 4000-gal scale manufacturing.

Robert Farner
Production Manager Drug Substance
Evonik Health Care
Vita

Robert has over 30 years’ experience in the development, scale-up and optimization of processes for specialty chemicals, drug substances and intermediates. This includes work with highly potent APIs, acutely toxic materials, and highly reactive compounds. Robert also provided leadership for a project that converted a development facility into a GMP and HPAPI-capable kilo laboratory.

Robert’s current role as a production manager at Tippecanoe Laboratories provides ongoing challenges with first-time scaleup of highly potent compounds at 20 to 100 kg scale.

Robert holds a B. S. degree in Chemistry from Purdue University.

Ben Larson
Manufacturing Director Tippecanoe Laboratories
Evonik Health Care
Vita

Ben has over 20 years' experience in the engineering, design, construction, and operation of pharmaceutical manufacturing facilities.

Over his career he has experience designing, building, and operating various scales of HPAPI production units at multiple facilities. This includes working with equipment providers, operations training and qualification, hazard review and communication, and audit readiness.

Ben is passionate about safety culture and also enabling technologies that support novel therapies to meet the patient's ultimate needs.

Ben holds a B.S. degree in Engineering from Purdue University.

Related webinars in this series

This is the third and last webinar of our 3-part webinar series entitled "Handling HPAPIs: From toxicological risk assessment to metric ton manufacturing". Join us to follow the journey of a highly potent molecule, starting from toxicological assessment to initial tech transfer and development onto large scale (metric ton) commercial manufacture.

To learn more about the two other webinars in this series please click on the respective webinar below. To register for multiple webinars of this series simply select them in the registration form.