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Strategies to Accelerate Development and De-risk Gene Therapy Manufacturing



WEBINAR

With its potential to treat a broader set of indications, the number of gene therapies under development is increasing. Concurrently, the need for accelerated and de-risked pathways to manufacturing is vital to delivering these critical therapies to patients. Having a robust process and analytical development (PAD) plan in place from the start is imperative, not only to drive the reduction of timelines, operation risks, and COGs but also to enhance patient safety.

Working with an experienced PAD team, who has the expertise, know-how, and capabilities to guide you in developing robust processes and analytical methods is instrumental to the success of your gene therapy.

Join our viral vector PAD experts as they showcase strategies for developing robust processes and analytics for efficient and de-risked manufacturing.

In this webinar, you will learn how we use bench scale studies to:

  • Accelerate development timelines
  • Optimize processes to maximize yields
  • Understand product quality attributes
  • Facilitate transfer and scale-up to production

Speakers

Hugh Murray

Hugh Murray

MilliporeSigma

Upstream Scientist

Hugh Murray is an upstream scientist for viral vector CDMO in Carlsbad, CA. With more than a decade of industry experience, Hugh has expertise in designing, optimizing, and scaling up mammalian cell culture processes for GMP manufacturing. He is passionate about using statistics and predictive modeling to incorporate data-driven decision-making in his development strategy processes. Hugh has a B.S. in genetics from UC Irvine.

Michael Born

Michael Born

MilliporeSigma

Senior Scientist

Michael Born is a senior scientist, analytical development for viral vector CDMO in Carlsbad, CA. Michael has been in the biopharma industry for more than 11 years and is accomplished in developing analytical methods, supporting process development, and transferring assays. He is passionate about bringing gene therapies to the rare disease community through testing critical quality attributes and demonstrating product safety and efficacy to regulatory agencies. Michael has a B.S. in bioengineering from SDSU and an M.S. in biotechnology from Northwestern University.

Dayne Callum

Dayne Callum

MilliporeSigma

Senior Scientist

Dayne Callum is a senior scientist, purification process development at our viral vector CDMO in Carlsbad, CA. She has more than 27 years in the biotechnology industry and specializes in the optimization and scale-up of clarification, chromatography, and TFF processes. Dayne has been instrumental in identifying facility fit and equipment constraints to de-risk and streamline technology transfer to manufacturing.

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