Discussing developments on Highly Potent APIs with industry expert, Richard Arnett for the HPAPI USA conference 2019
Ahead of the 2019 HPAPI USA Conference taking place in Boston on 21st – 22nd October, SMi caught up with Richard Arnett, Manager, Industrial Hygiene, Pharmascience who is speaking on Day Two of the agenda. Richard shared his thoughts on how the industry has developed and briefly touched on what he will be discussing in October. At this year's HPAPI USA Conference, emerging manufacturing technologies will be one of the key points to be discussed, along with containment issues, disaster management, Oncology Antibody-Drug Conjugates (ADCs) and staff training procedures.
Snapshot of Richard’s Interview:
What key differences have you noticed in the last year regarding significant developments in Highly Potent APIs?
“Three main points: Higher potency, particularly for OSD products Lower ADE, often poorly soluble and tougher to clean APIs Closer scrutiny by regulatory agencies. For example Health Canada is now more closely aligned with the EMA and there’s now a more harmonised approach, with a mutual recognition agreement in place which sets the bar to the appropriate level, not just with the regs/GMP’s, but also through compliance/enforcement ensuring that the appropriate controls are in place to mitigate cross-contamination risks…”
What do you see as the greatest challenge for you to overcome personally in the Highly Potent API field currently?
“Changing the culture from traditional ‘open processes’ to closed processing with reduced reliance on PPE & thus reduced worker-product exposure risk. I often hear ‘what’s the risk – the workers are wearing respirators’– and there remains a perception that this is adequate… But what about when the airborne concentration might exceed the assigned protection factor of the respirators? Or what about the exposure risk when the respirators are removed?...”
Richard will be joined at the conference by a number of key figures in the HPAPI industry including Rakesh Dixit, Vice President of R&D Global Head, MedImmune; Vice President of R&D Translational Sciences – Biologics Safety Assessment, AstraZeneca; Janet Gould, Senior Managing Toxicologist, SafeBridge Consultants USA and many more.
For the full speaker interview, event details and speaker line-up, it is available to download at www.hpapi-usa.com/openPR6
Proudly Sponsored by BSP Pharmaceuticals | LONZA | Minakem | SafeBridge Consultants
Highly Potent Active Pharmaceutical Ingredients USA
Conference: October 21st – 22nd
Workshops: October 23rd
Venue: Sheraton Boston Hotel, USA
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About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
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