About Event

Why Attend the 14th Highly Potent Drug Manufacturing Summit?

In pursuit of CMC excellence in oncology and other therapeutic areas requiring high potency compounds, the Highly Potent Drug Manufacturing Summit is returning with a dramatic transformation to reflect the growing needs of the industry.

For 14 years, we’ve united some of the most knowledgeable experts across pharma, biotech, CDMOs, generics, and regulatory bodies who are all keen to shape the future of high potency drugs.

This year, we’re taking on a strategic approach to tackle the challenges that surround manufacturing safety, regulatory compliance, and innovation in drug development and delivery to seek incredible outcomes.

Key Sessions You Can’t Miss:

Join 90+ Vice Presidents, Directors, and Heads of CMC, Tech Operations, Process Chemistry, Drug Substance and Product, EHS, and Industrial Hygiene to...

CREATE
compound-specific assessments for optimal decision-making of route design in process chemistry to minimize the number of highly potent steps in API development with Biogen

IDENTIFY
the precise composition of ADCs for the ideal delivery format to tackle challenges with conjugation platforms and streamline transition into clinical trials with Johnson & Johnson

INCORPORATE
the usage of Lyoprotect bags in early R&D for controlled exposure during lyophilization to reduce any risks of cross-contamination from open transfer systems with AstraZeneca

ESTABLISH
robust systems for quality assurance of pilot plants and shared facilities to ensure GMP compliance and protect workers from handling OEB4+ compounds with Bayer

STANDARDIZE
occupational exposure bands with partnering CDMOs for transparency across multiple R&D sites to align expectations in occupational health and safety with Bristol Myers Squibb

FULL EVENT GUIDE

Who Will You Meet?

Our long-awaited, reputable forum is your golden ticket to join and network with 90+ Vice Presidents, Directors, and Heads of...

- - CMC,
  - Tech Operations,
  - Process Chemistry,
  - Drug Substance and Product,
  - EHS,
  - and Industrial Hygiene

...all under one roof – with the shared interest of integrating process development, green chemistry, and equipment selection to achieve GMP compliance for high potency compounds.