The successful development and manufacturing of highly potent molecules was the theme of our webinar which took place on 8th September 2016
Hosted by European Pharmaceutical Manufacturer magazine, the webinar has enabled professionals working in the field of highly potent molecules to understand the complexities of safe processing and key considerations when it comes to choosing an outsourcing partner. The presentation was delivered by Colin Newbould, Director of Quality, International at PCI Pharma Services.
Commenting on the theme of his presentation, Colin said: “The pharmaceutical landscape continues to evolve with R&D pipelines continuing to develop new chemical entities for a wide range of disease states. The market has seen a shift towards more specialist medicines such as oncological and neurological products, in turn leading to an increase in the number of potent compounds requiring expert management.
“With the complexities involved in the management of potent molecules and the regulatory requirements to ensure safe handling, it is imperative to use the right partner for successful development and manufacturing of highly potent molecules.”
PCI’s free learning event enabled participants to understand:
- The complexities of processing of highly potent molecules
- The regulatory requirements for the safe handling of highly potent molecules
- Key considerations when choosing a potential outsourcing partner for successful development and manufacturing.
Colin has more than 27 years’ experience in the industry, specializing in pharmaceutical manufacturing and development, quality assurance, and oleochemical research. His current role at PCI is to oversee quality of the regulatory supply chain, ensuring world-class compliance, effective processes, and customer satisfaction. He is also an accredited EU Qualified Person under permanent provisions and, together with his team, supported the regulatory pre-approval and approval inspections of the high potent Contained Manufacturing Facility at PCI’s Tredegar site.
Please feel free to contact the PCI team firstname.lastname@example.org
More about Our High Potent Manufacturing service
Our specialized high potent manufacturing expertise is built on 35 years of experience in potent processing and offers a purpose-built facility utilizing the very latest in containment technology. This enables the safe development and clinical and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m3.