Pharmaceutical R&D is focusing on developing ever more specialized drugs, resulting in increasingly more potent APIs. Therefore, the demand for highly potency drug product manufacturing has been steadily increasing over the years and this trend is expected to continue. With this need comes the importance of various handling procedures, safety controls, and OEL protection. Executing an efficient and optimal highly potent strategy early on can set a strong foundation when it comes time to scale up the manufacture of the highly potent drug product.

During this session, you will learn from industry experts about:

  • Highly potent drug product challenges and strategies from early development to commercialization
  • Small-scale and large-scale equipment (non-GMP)
  • Overview of industry standards and beyond
  • OEL containment and safeguard of facilities, engineering controls, personnel
  • Segregation of manufacturing areas
  • Case Studies

Featured Speakers

Julianna Woo

Senior Manager, EHS
Thermo Fisher Scientific

Julianna Woo has 18 years of experience in the EHS field; 16 of these years have been in the pharmaceutical industry. Prior to joining Thermo Fisher Scientific, she worked at GlaxoSmithKline, Teva, and General Electric. She has a Bachelor Degree in Toxicology and a Master Degree in Occupational & Environmental Health / Industrial Hygiene, from the University of Toronto.  She also has completed the Canadian Registered Safety Professional (CRSP designation). Her focus of expertise is in Occupational Exposures and Industrial Hygiene in the pharmaceutical industry.

Milan Babu

Senior Manager, Pharmaceutics & Process Technology
Thermo Fisher Scientific

Milan Badu has a Ph.D. (Tech) in Pharmaceutical Science and a degree in General Law. He has over 30 + years experience in pharmaceutical product / process development for oral solids, liquid orals, semi solids and ophthalmic. In addition to this, he has experience in developing drug products for Generic, NCE and Life extension of products.

Jonathan Laba

Director, Technical Operations
Thermo Fisher Scientific

Jonathan Laba has over 20 years of experience in the pharmaceutical industry working in various manufacturing and engineering roles within both oral solid dose and steriles.  He has been involved in design through implementation of manufacturing processes utilizing containment and isolator systems.  In his current role, he leads the Technical Operations team at Thermo Fisher Scientific’s Mississauga high potency site.  Previously he has worked with AstraZeneca and Johnson&Johnson, as well as various biopharmaceutical and CDMO clients as a consultant.

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