HPAPI Summit hones in on pharmaceutical manufacturing risk

By Jenni Spinner

- Last updated on GMT

(koto_feja/iStock via Getty Images Plus)
(koto_feja/iStock via Getty Images Plus)

Related tags HPAPI API Fda Manufacturing Safety Merck Eli lilly Takeda

The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.

Like many industry events, the 11th annual Highly Active Pharmaceutical Ingredients (HPAPI) Summit​ is returning to an in-person format. Outsourcing-Pharma spoke with Jennifer Small (brand director of process innovation and pharma manufacturing for show organizer Hanson Wade) to learn more about the event, and the content the agenda offers for industry professionals.

OSP: Please share your perspective on the growth and changes in the HPAPI market since the last time the Summit convened in person.

JS: Plenty has changed over the past three years since the HPAPI community last met face-to-face in 2019. There has been a boom in new high potent capacity facilities, including millions of dollars invested in new facilities and expansions from Sanofi, Sterling, Lonza, and many others in recent times. Several new facilities are boasting ADC production capabilities, with the approval of four ADCs in the US during 2021 & 2020; growing the HPAPI market since the last time the Hanson Wade HPAPI community met in person.

With an increasing number of highly potent and hazardous pipelines being developed within the pharmaceutical industry, internal & external manufacturing capacity is becoming stretched, hence the importance of forums like this one to understand the most efficient, regulatory compliant, and robust manufacturing routes. Lastly, it’s no secret that the pandemic and other factors have caused supply chain havoc, leading our community to reassess a single-use approach, and develop new cleaning procedures.

OSP: The show itself has changed a bit since its inaugural event in 2012. Could you please tell us about some of the history of the HPAPI Summit​, and the new features you’ve added for the 2022 program?

JS: The HPAPI Summit first started as an intimate forum 11 years ago, launched shortly after the inaugural iteration of Hanson Wade’s World ADC Summit, as the first and only event dedicated to industrial hygiene in Highly Potent APIs. Whilst this first event boasted an audience of 50 people, we have since grown to a multi-functional senior audience of over 200. The Summit is now dual-tracked to tackle industrial hygiene, EHS & Occupational Toxicology within potent products as well as the technical and strategical aspects of High Potent & Hazardous Production such as Process Development, Manufacturing, Outsourcing & Tech Transfer.

The program has also expanded beyond small molecule APIs, to include drug conjugates, hazardous large molecules, and new modalities, as the production hazardous of these evolving pipelines come to light.

OSP: As your website reflects, the programming will focus on risk management (i.e. “De-Risking Highly Potent APIs & Hazardous New Modalities”). Could you please tell us a bit about why this topic is so important an area to tackle?

JS: To paraphrase a recent interview with HPAPI presenter Elizabeth Vancza, who is Associate Director of Occupational and Environmental Toxicology at Merck & Co; we don’t know what we don’t know. With some of the newer modalities, we're combining drugs & technologies that are already known, leading to a false sense of security, when we need to understand that sometimes the sum of the parts does not equal the whole.

We need to explore how these can act in a synergistic way and have additive effects to truly understand the risk of these new modalities and what the safety implications are going to be.

When it comes to more traditional small molecule APIs, we will be exploring ultra-high potent OEB 5 substances, and how to manage risk and cost in the production of these next-generation HPAPIs.

OSP: Could you please tell us about some of the speakers on the schedule, and what they might bring to the table?

Jennifer Small (brand director of process innovation and pharma manufacturing, Hanson Wade)

JS: One speaker physically bringing something to the table, is the Director of Engineering, MRL, New Technology Development & Potent Containment at Merck, John Roosa. John is presenting on creating and utilizing an interactive virtual reality environment in Merck’s recent facility design and is bringing along a few VR headsets for the audience to try out at the event!

A few other program areas we’re eagerly awaiting are our scale-up and tech transfer sessions led by AbbVie and Pharmascience, a tox panel on Exposure Risk Vs Potency from AstraZeneca & Merck & Co, and a co-presentation on Industrial Hygiene’s role in utilizing ventilation to form sustainable laboratories from Brian Schmidt, Global Lead Occupational Hygiene and Andrea Guytingco, EHS Business Partner at Takeda Pharmaceuticals.

We’re glad to be hosting a world-leading lineup this year, with quality presentations from the likes of Eli Lilly, Merck, Takeda, AstraZeneca, CSL Behring, US Pharmacopeia, Bayer, AbbVie, Academia, and Generic companies, alongside our partnering solution innovators including ILC Dover, SafeBridge, WuXi STA, Affygility Solutions and many others.

OSP: What other programming on this year’s Summit agenda would you like to highlight?

JS: Every year we hear a winning highlight for our attendees is the workshop sessions. Small interactive working groups focused on three key challenges that our community has highlighted as priority areas to solve. This year the following topics have been selected and are set to have many thought-provoking discussions, exercises, and even games set up to tackle:

  • Nitrosamine Impurities (led by US Pharmacopeia)
  • Understanding Human Error in EHS (led by MeiraGTx)
  • Applying Traditional HPAPI Principles to Large Molecules (led by Merck & Co.)

Looking a little further ‘out-of-the-box’ we’ll also be drawing process safety inspiration from the Radiopharmaceutical & Gene Therapy fields with case studies from MeiraGTx (Head of Environmental Health & Safety) & Bayer (Scientist External, CMC).

Finally, for the first year in its history, the 11th HPAPI Summit is CPD certified, which we felt was an important step to ensuring high-quality actionable content, allowing our attendees to ensure their knowledge and certifications are up to date.

OSP: This year’s program is in person, rather than virtual—could you please tell us why organizers decided to return to face-to-face and the benefits of attending an in-person event?

JS: No matter the format, we always pride ourselves on providing quality insights from an industry-driven, peer-led speaker faculty. However, nothing can compare to the additional learning opportunities gained from conversations in networking sessions, over lunch, in the expo area, or just at your table with your fellow attendees. The lack of these candid conversations, reaching beyond what’s been approved by legal to share, has stagnated innovation over the past two years and it is integral we provide a ripe platform for these conversations to happen again.

We’re excited to be hosting many networking opportunities across the three-day conference in June, including a complimentary evening drinks reception for all attendees to enjoy reconnecting with their community this Summer.

OSP: Did you have anything else to add?

JS: We hope to see as many faces, old and new, as possible join us in Boston this June 28 -30. Hence we are running an ‘early bird’ discounted rate for registration. This is expiring shortly so confirm your place today to ensure your seat at the best possible rate.

The 2022 HPAPI Summit is scheduled in Boston, from June 28 to June 30. Learn more or register here.

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