Q&A with SKAN AG speaker released for HPAPI 2020
The 4th annual Highly Potent Active Pharmaceutical Ingredients conference will take place on the 11th – 12th May in London. The event will involve key profiles from leading pharma organisations to meet and discuss HPAPI manufacturing, where delegates will gain a better understanding of the oncology market and ADC production which is one of the main forces in the HPAPI industry.
The two-day conference will also explore the challenges in the industry, such as determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.
Ahead of the conference, SMi caught up with SKAN AG’s Senior Consultant, Aseptic Processing & Containment Richard Denk, to review his insights on how the HPAPI market is developing, the importance of the 2020 conference, along with containment issues and challenges.
Snapshot of Richard’s interview:
In your opinion, what are the current market drivers of the HPAPI industry?
"BioPharmaceuticals, Oral Solid Dosage Forms, API`s and the development of new novel medicines are one driver for the HPAPI Industry other drivers are regulatory requirements from the EMA. Since the EMA published the Guideline on setting health exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, every product requires a PDE “Permitted Daily Exposure” and is calculated by experts. Beside Occupational Safety Requirements, GMP Requirements now also drive the expansion of Containment solutions".
As a containment expert, what would you say is the importance of a meeting on Highly Potent APIs? What major issues would you say are important to discuss in 2020?
"There are several important topics to cover in 2020. Within containment, for 20+ years we have been discussing protecting the operators from the hazardous substance. As a result, a lot of Containment Solutions and Transfer Systems are developed and many of them are successfully in use. Almost all of them have one common challenge that the operator has to get close to, the Containment connection of the hazardous substance. This could be for example on a flexible bag solution where the operator has to do some manipulation to make the Containment work. As one of the topics I`d like to highlight automation of containment for keeping the operator away from the hazardous substance..."
There will also be 2 interactive half-day post-conference workshop held by Justin Mason-Home, Director, HPAPI Project Services Limited, on the 13th of May to focus on “Practical Steps for Delivering HPAPI Projects.” as well as David Embrey, Managing Director, Human Reliability Ltd. On “A roadmap to enhancing organisational safety in HPAPI manufacturing: A Human factors perspective”.
For the full interview, speaker line-up and more information on the conference and registration, visit: http://www.highlypotentapi.com/PHARMAnewshqpr4
