As an HPAPI project proceeds through the development lifecycle and into clinical trials, the understanding of the risks associated with the potent compound increases and risk mitigation generally becomes less difficult. Although many challenges exist for high-containment API manufacturing, the variability and uncertainty associated with each compound present the greatest risks.*
Gregory Sowell, Principal Scientific Manager, Small Molecule Process Chemistry, from Genentech will be presenting on day 1 this May, and will be exploring the management of highly potent projects from early development stages. Dr. Sowell has over 25 years of pharmaceutical experience in small molecule process development and manufacturing. He has been at Genentech for the past 10 years where he leads a team of process chemists as well as heads the small molecule GMP API manufacturing facility.
Below is a summary of Gregory’s presentation:
‘Practical Approach to HPAPI Manufacturing in Early Development’ – Day 1 | 09:50.
– Designing, building and working in a multiproduct kilo lab environment
– Risk analysis of entire synthetic process based on factors including process safety and industrial hygiene
– Important link between surrogate testing of equipment, training staff and process specific equipment needs
– Ensuring proper transfer of safety information to CMOs
The opening presentation on day 2 will be presented to you by Vincenzo de Sio, Especialista, from Cristalia Produtos Quimicos Farmaceuticos, and will be looking into the waste and containement considerations of highly potent APIs.
Alongside the risks which are associated with the handling and containment during the manufacturing of HPAPIs, there are also risk mitigation and containment measures which need to be taken post-production. Waste disposal of potent ingredients poses further issues and considerations, in terms of the handling of the hazardous residues. Further processes also need to be implemented in order to prevent environmental contamination.
Below is a summary of Vincenzo’s presentation:
‘Waste management for Highly Potent APIs’ – Day 2 | 09:10.
– Risks after manufacturing processes: Liquid and solid residues of HPAPIs and related risk of contamination
– Waste disposal and waste treatment: How to handle a hazardous residue and how to avoid environmental contaminations
– Deactivation systems and procedures: Why and how to transform a hazardous compound in less toxic substances
Further information is available at: www.highlypotentapi.com/pmagpr
SMi presents the 2nd Annual:
Highly Potent Active Pharmaceutical Ingredients (HPAPI)
Date: 21st – 22nd May 2018
Workshops: 23rd May 2018
Location: Holiday Inn Kensington Forum, London UK
For all media inquiries contact Pavan Solanki on Tel: +44 (0)20 7827 6048 / Email: email@example.com
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