Improve Fill-Finish Yield for Today’s High-Value Drug Products

The number of biologics and complex drug products entering clinical trials and the market is rising, and many of the active ingredients are either incredibly expensive or time-consuming to produce. High-value drug products, like these, can cost upwards of $500,000 for only a liter of drug product, the same volume that many fill-finish CDMOs will tell their clients to expect to lose during their drug manufacture.

The standard volume losses many manufacturers consider “acceptable” are no longer sustainable, especially for small-batch, high-value therapies. This webinar addresses product loss in aseptic fill-finish and outlines practical ways to preserve more drug product.

Why does product loss occur in aseptic fill-finish, and how can a CDMO overcome material constraints to preserve as much drug product as possible for clients with rare or expensive APIs? In this webinar, the featured speakers will examine the key drivers of product loss during sterile fill-finish and outline practical, experience-based solutions to mitigate them. Attendees will gain insight into how equipment selection, process parameters and operational techniques can be optimized to preserve valuable drug product, while also maintaining quality and regulatory compliance.

The session will also highlight commonly used, but high-risk, approaches that can ultimately do more harm than good. Finally, attendees will learn about an innovative fill-finish approach that can further increase product yield in small-batch fills and provide actionable guidance to help you reduce waste, control costs and maximize yield.

Register for this webinar to learn how fill-finish strategies can reduce product loss, protect yield and support compliant manufacturing for high-value drug products.

Speakers

Tyler Rush, VP of Manufacturing, Special Projects, Sharp Sterile Manufacturing

Tyler Rush is a results-driven leader with extensive experience in the cGMP operations environment. Rush has over 37 years of experience working in drug development and manufacturing.

Before joining Sharp Sterile, Tyler worked as a Senior Director of Manufacturing Operations, where he provided strategic direction, oversight and technical leadership to manufacturing, contract manufacturing, materials management and facilities operations. Prior to this role, Rush served as an Associate Director of Operations, where he managed all aspects of reagent manufacturing, consumable cartridge manufacturing, QC, materials management and facilities.

Tyler earned his BS in Biology at Denison University in Granville, Ohio.

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Xufeng Sun, VP, Manufacturing Science and Technology, Sharp Sterile Manufacturing

Xufeng Sun is a proven leader in complex formulation and tech transfer for the development of injectable products. Sun has over 15 years of experience in pharmaceutical development. He oversees a team of engineers for filling and formulation, as well as formulation and lyo development.

Xufeng joined Sharp Sterile as the Director of Formulation and Tech Transfer after 12 years working in pharmaceutical development, where he managed a pharmaceutical development team, led injectable drug product development and technical transfer to fill/finish sites. Xufeng was promoted to Vice President of Formulation and Tech Transfer at Sharp Sterile in 2021.

Xufeng has a Doctorate in Organic Chemistry from Rensselaer Polytechnic Institute, and an MS and BS in Analytical Chemistry from Xiamen University.

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