Encap Drug Delivery, UK

Encap Drug Delivery, UKencap-logo

Lead contact: Dr. Paul Higgins

Email: PHiggins@encapdrugdelivery.com

Web: www.encapdrugdelivery.com

ENCAP was established in 1989 to exploit an emerging new oral drug delivery technology - liquid and semi-solid filling of two-piece hard capsules (LFHCs). The company has grown organically and steadily over the years and is now recognised as the world leader in this field. ENCAP comprises around 50 employees, 5 of whom are formulation scientists, 7 are analytical chemists, 6 are quality control, 4 are quality assurance and 12 are production staff. To date over 20 licensed products have been manufactured. In addition to the mnufacturing business, ENCAP has established a well respected Development Services organization. The company is widely acknowledged as the world leader in this area and provides clients with fully integrated analytical and formulation development services and clinical trial manufacturing. The company has a wide range of expertise including Analytical, Formulation, and Process Engineering and Manufacturing skills. ENCAP covers all aspects of QC and analytical testing and have recently opened a new microbiological testing lab. ENCAP has the capability to develop analytical methods and routinely carry out testing to US and European pharmacopeal standard. We can also structure a stability program tailored to each product, carry out all necessary tests and provide fully qualified reports. ENCAP operates to cGMP, holds an MHRA Licence for Investigational Medicinal Products (IMP's) and is able to meet the stringent quality requirements set by the world's most demanding regulatory bodies. Furthermore, ENCAP were inspected by the FDA in March 2008 and in November 2008 their Oakbank Park facility was deemed acceptable by the FDA, based on the finished drug product that ENCAP were inspected for.

Short profile of the staff members who will be undertaking the work:

Dr. Victor Young is the Head of Formulation and Development, with 25 years of pharmaceutical experience, including 20 years of encapsulation at ENCAP. He has undertaken various roles at ENCAP, including Quality Control Manager, Production Manager and Formulation Development Manager, and is a Member of the Royal Society of Chemistry (MSRC), with a PhD in Chemistry.

Alyn McNaughton is the Head of Analytical Development, supervising validation and stability teams at ENCAP. He has a MSc in pharmaceutical analysis and over 16 years of analytical chemistry and pharmaceutical development experience. He has over 10 years of analytical method transfer, development and stability testing within liquid-fill technologies at ENCAP.

Kenneth Milne is the Head of Quality Control at ENCAP. He has 30 years experience in the pharmaceutical industry in various analytical roles such as pre-formulation, analytical method validation and transfer, stability testing and Quality Control.

Joe Darling is the Quality Assurance Manager, supervising QA officers and validation teams at ENCAP. The main responsibilities of the QA team are carrying out audits, control of GMP documentation and approval of protocols, reports, and stability data. He is a Member of the Royal Society of Chemistry (MRSC) and holds a BSc in Applied Chemistry. He has 22 years experience in the pharmaceutical industry including 6 years at ENCAP, and recently qualified as a QP (Qualified Person) for commercial and investigative medicinal products (IMPs) for capsule products.

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