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On-demand webinar

Navigating challenges in HPAPI development and manufacturing

HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.

Watch this webinar discussion for free!

Highly potent drugs have become a major component of the new chemical entity (NCE) small molecule drug pipeline with significant growth over recent years. High potency active pharmaceutical ingredient (HPAPIs) now account for more than half of clinical small molecule NCE drugs. This growth is driven by significant advance in oncology treatments and the development of targeted precision medicines. This is an exciting area but also one that requires specialist expertise and equipment to support development and manufacture of high potent drugs.

The considerations in developing and manufacturing HPAPIs include product containment, personnel protection and management of cross contamination risk. Although the process requirements for HPAPIs are typically no different to less toxic APIs however the toxicity of HPAPIs demands specialized facilities and equipment to ensure the safety of personnel and the environment. Containment strategies are critical, with a need for state-of-the-art engineering controls, personal protective equipment, rigorous procedures and specialist training. Cross-contamination risks further intensify the complexity of HPAPI handling which require robust cleaning procedures and verification.

The handling of High Potent Active Pharmaceutical Ingredients requires an experienced CDMO partner who has the knowledge, infrastructure, and commitment to safety necessary to overcome these challenges. Thermo Fisher has more than 30 years experience in this space.

Key takeaways

  • HPAPI toxicity and safety requirements
  • Containment approaches during HPAPI development and manufacturing
  • How to mitigate the risk of cross-contamination.

Listen to our speakers answer further questions too.

OUR SPEAKER

Karl Doherty, Director of Business Management, API

Karl has been with the commercial group of Thermo Fisher since 2019, working with emerging pharma and large pharmaceutical clients, supporting the development lifecycle taking projects from early clinical through to commercialization. Prior to joining Thermo Fisher Karl worked with a number of companies with a specific focus on the design and operation of facilities managing the development and manufacture high potent API.

Dr. Joe Galati, Senior Director of Global Toxicology Services, API

Dr. Joe Galati is the Senior Director of Global Toxicology Services and has 20 years of experience in the pharmaceutical industry, in the field of occupational toxicology and patient/product safety. Involved in evaluating the toxicity of compounds (active pharmaceutical ingredients, intermediates, contaminants, etc.) in order to assign appropriate toxicity categorizations/bands, determine low potency versus high potency, and develop occupational exposure limits for worker safety, as well as threshold of toxicological concern/permitted daily exposure/acceptable daily exposure values for patient safety. Also involved in identifying whether the handling of compounds complies with the requirements for Good Manufacturing Practice in a multi-product facility and advising on potential drug product quality/regulatory concerns, such as cytotoxic, cytostatic, hormone, sensitizer, and others. A full member of the U.S. Society of Toxicology, as well as the Society of Toxicology of Canada, with a Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto. Also, an author of several peer-reviewed publications, and a presenter at various international scientific meetings, conferences, and universities, in North America and Europe.

Aengus Grant, Quotation Manager, Thermo Fisher

Aengus has over 17 years of experience in the pharmaceutical industry, initially as a chemical engineer in production and then in process technical transfer and new product transfer/introduction. He joined Thermo Fisher Scientific in 2016 as a quotation manager.  In the last 5 years he has worked supporting quotations including assessing technical fit, materials quotations and project/production planning for new products for customers of both standard and high containment.  Aengus holds a BSc in chemical engineering and also holds professional accreditations in Chartered chemical engineer, European engineer and Professional Engineering.

ABOUT US

Thermo Fisher Scientific is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help pharmaceutical and biotechnology customers accelerate innovation and enhance productivity throughout the drug discovery, development and production process. We provide a broad range of products including chromatography and mass spectrometry solutions and end-to-end pharma services solutions for every drug development journey.

FAQs

FAQs

Is the webinar free? 

Yes – there is no charge to watch the webinar, either live or on-demand. 

When will the webinar take place? 

29th November 2023 at 3.00pm GMT. 

Can I watch it later? 

The webinar will become available to watch on-demand shortly after the live webinar takes place. 

What are the benefits of attending live? 

You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session. 

How long will the webinar be? 

This webinar will last up to an hour. 

What do I need to watch this webinar? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.