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Update on Penn Pharma. John Roberts, Commercial Director December 2012. The Business. Penn provides an integrated range of services to an international client base. Pharmaceutical Development Manufacturing & Packing Support Services
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Update on Penn Pharma John Roberts, Commercial Director December 2012
The Business • Penn provides an integrated range of services to an international client base. • Pharmaceutical Development • Manufacturing & Packing • Support Services • Headquartered in South Wales since 1986, with 300+ staff (>95% local) on 2 sites. • Trading for over 30 years, Penn is approved by MHRA (UK) and FDA (USA) • Recognised for its export experience, Penn supplies EU, USA, Japanese, Australia and South American markets (Queen’s Award Winners 1993 and 2010) • £30m turnover with objective to double in next 4 years.
Core Services • Pharmaceutical Development • Formulation Development • Analytical Development • Clinical Supplies • Manufacture & Packing • Solid Oral Dose • Creams/Ointments/Gels • Oral Liquids • Clinical Trial Batches • High Containment • Controlled drugs • Support Services • QP Services • Storage & Distribution • EU Portal Importation & Distribution
Penn & Welsh Government Support • Established in Penn, Bucks in 1979 and relocated to South Wales in 1986 with WDA support. • Received consistent export marketing support from WDA, IBW, and more recently WG (e.g. overseas visits, exhibitions, trade missions). • Substantial support for training and development in technical and management skills - Workforce Development Scheme, Skills for Growth Scheme etc. • Most recently, WG provided a capital grant to help fund important further expansion and job creation, as part of a £14m total investment……….
Penn Contained Manufacturing Operations • A bespoke facility dedicated to the development and manufacture of potent, oral solid dose products.
Potent compounds • Drugs with pharmacological activity at doses of 1mg or less • Cytotoxic/cytostatic/immunosuppressive drugs • Teratogenic/embryotoxic drugs • Carcinogenic/mutagenic drugs • Certain hormones • Drugs with a known or estimated OEL of ≤10µg/m3 8h TWA
Business Case for Investment • For many years Penn has successfully developed and manufactured ‘potent’ products requiring the use of ‘contained operations’ to protect both employees and customers. • The number of ‘potent’ compounds requiring oral solid dosage form development and subsequent manufacture at the clinical and commercial scale is increasing, esp. in oncology . • More than 1500 potent compounds in development by the pharma industry. • Shortage of suitable state-of-the art facilities worldwide. • Increasing outsourcing of development and manufacturing, esp. of potent compounds. • Consequently we have decided to invest in a new facility to manufacture oral solid dosage forms within contained operations.