While the rapid development of COVID-19 vaccines helped to wind down the pandemic, it also brought to light the many challenges involved in ramping up the production of injectables that must be made in sterile, aseptic environments. Several companies struggled to compress what’s normally a year-long process into a matter of months.

Pitfalls can be avoided, however, by improving planning processes and adopting new technologies to streamline manufacturing. As manufacturers expand beyond small molecules and first-generation biologics into more complex molecules such as gene therapies and mRNA vaccines, they’ll need to embrace these new tools.

Topics include:

  • How virtual reality, robotics and other advanced technologies can improve the efficiency and safety of the manufacturing process
  • The latest in in isolator-based technologies designed to protect against contamination
  • Learnings from the COVID-19 vaccine ramp-up that can be applied to the future production of sterile injectables

Featured Speakers

Michelle Logan

Vice President and General Manager, Drug Product North America
Thermo Fisher Scientific

Michelle Logan is Vice President and General Manager for Drug Product North America at Thermo Fisher Scientific, which includes all Steriles and Solid Dose manufacturing sites across the United States, Puerto Rico and Canada. With over 20 years in the pharmaceutical industry, she joined Thermo Fisher in 2017 through the Patheon acquisition and has held multiple leadership and operations roles within the organization including Vice President and General Manager of Thermo Fisher’s Greenville, N.C. site which is among the company’s largest sites. Prior to joining Thermo Fisher, Michelle led the Quality organization for medical device company, Coeur, Inc., and was part of the External Manufacturing Quality organization for GlaxoSmithKline. Michelle graduated from UNC Chapel Hill with a BS in Biology.

Thomas Becker

Quality Director and Qualified Person
Recipharm

Thomas Becker is Quality Director and Qualified Person for vaccines at our facility in Wasserburg. Thomas, who also has a PhD in chemistry from the Friedrich-Alexander University in Erlangen-Nürnberg, has more than 20 years’ experience in the pharmaceutical industry, most notably in aseptic production of liquid and lyophilised injectable drug products and vaccines. Prior to joining Recipharm, he held several senior positions including site quality head and director regulatory compliance over a span of 14 years.

Vincent Quiles-Pelletier

Quality Management and Head of Steriles
Recipharm

Vincent is Director, Quality Management and Head of Steriles at Recipharm. He’s in charge to support all the company’s sterile operations across 12 of its facilities as well as overseeing all quality functions. With almost 25 years of experience in the pharmaceutical industry, Vincent has an in-depth understanding of quality requirements and ensuring customer projects are delivered to the highest standards. He has a PhD in Pharmacy from the University of Pharmacy, Tours, France.

Jason Winfield

Head of Engineering
Civica Rx

Jason is a biopharmaceutical leader (biotech, small molecule, and vaccines) with extensive cross functional experience with complex and challenging environments. He is skilled at initiating metric-driven quality enhancements, process improvements and operational efficiencies resulting in increased capacity and reduced costs. His specialties include strong strategic and analytic skills, interpersonal relationships, ability to articulate complicated scenarios in a succinct manner, and developing, supporting, and encouraging team collaboration for peak performance.

Alex Fox

Manufacturing Technical Specialist
Grand River Aseptic Manufacturing (“GRAM”)

Alex Fox plays an integral role at Grand River Aseptic Manufacturing with the formulation, filling and lyophilization of sterile injectable products. He is an expert on GRAM’s equipment and technology which includes a Bausch+Ströbel vial filler, SKAN isolator, and IMA lyophilizer. Alex made an impact when the company was called upon to support the U.S. government’s Operation Warp Speed efforts and COVID-19 pandemic response. GRAM partnered with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine. Alex was on the front line when GRAM sped up operational readiness by six weeks to provide fill/finish services for Johnson & Johnson’s COVID-19 vaccine at its large-scale facility in Grand Rapids, Michigan.

Alex joined Grand River Aseptic Manufacturing in 2013 as a Production Operator before his promotion to Production Supervisor, then to Manufacturing Technical Specialist. He graduated from Michigan State University with his Bachelor of Science in Natural Science. Alex continues playing a critical role in implementation of manufacturing processes and equipment as the company expands on its large-scale facility with an additional Bausch+Ströbel vial filler with SKAN Isolator and a new modular VarioSys® syringe and vial filler.

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