How Aseptic Filling Can Make Up Lost Time in a Drug Development Program

Pharmaceutical companies have spent the past eight months strategizing and waiting for clinical trials to resume. Now that product development has resumed, aseptic filling is a crucial step — and possible bottleneck — to regaining lost time.

Whether companies are looking for a contract manufacturing organization (CMO) or bringing filling operations in-house, this webinar will help to drive faster decision making around the establishment of a manufacturing strategy.

Featured speakers will be looking at how companies can prepare themselves to get filling started quickly, covering topics like:

• The influence of filling technologies on key quality and performance metrics
• The benefits of selecting standardized containers and closures
• The importance of creating user requirements, specifications and batch documentation

This webinar will share examples of how Vanrx and Singota have worked with customers to advance drugs through the clinic and establish filling operations.

Speakers

John Harmer, Vice President, Marketing, Vanrx Pharmasystems

After more than 30 years in the pharmaceutical industry, John Harmer has experience in just about every aspect of drug development and manufacturing. In addition to aseptic filling, he has worked in API production and process development, device development, clinical trial logistics and regulatory submissions for novel therapeutics. Harmer understands the timelines and challenges of the drug development process and is a valuable technical resource for Vanrx’s customers.

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Brent Lieffers, Senior Director of Operations, Signota Solutions

Brent Lieffers has nearly 30 years’ experience in the pharmaceutical industry, from API manufacture through aseptic filling to final drug product packaging, in operations ranging from small clinical to large commercial-scale production. His contributions in multiple startups have included technology transfer, equipment selection and validation, regulatory submission preparation, and managing both regulatory and client inspections. Lieffers has strengths in continuous improvement, process optimization and cross-function/facility harmonization. Lieffers received his Bachelor of Science from Pepperdine University.

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