From Conception to Completion: Delivering Drugs of the Future Dana Shears Presspart Manufacturing Ltd Email: dana.shears@presspart.com
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Biography Mr. Dana Shears has spent the past 5 years with Presspart Manufacturing Ltd., part of the Heitkamp and Thumann Group, currently as the Sales Director for Presspart Nemo. He is responsible for sales and business development of MDI canisters and actuators within the Americas and global coordinator for the group’s pharmaceutical and medical plastics business. Prior to joining Presspart, Mr. Shears held business development and marketing positions with Bespak, Honeywell, AAI Pharma and Nypro. Mr. Shears received his B.S. Degree in Engineering from West Virginia University in 1981. In addition, he has furthered his business studies at Tulane University, Kellogg and Cranfield School of Management. Company Profile Presspart and Presspart Nemo specialise in high precision, metal and plastic components and drug delivery devices for the pharmaceutical industry. With over 35 years’ experience in supplying deep-drawn metal MDI canisters, MDI valve components, plastic actuators and new drug delivery devices, both divisions constantly study, refine and optimise their processes to ensure optimum quality and performance for customers. Presspart and Presspart Nemo are leading suppliers and partner to many of the world’s largest pharmaceutical producers.
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Abstract 1) Contract manufacturing Vs In house manufacturing – a changing landscape? With increasing costs and stricter regulatory restrictions, many pharmaceutical, medical and healthcare companies are choosing to outsource their manufacturing processes to contract manufacturing organisations (CMO’s) in order to improve productivity and efficiency. CMO’s can provide innovative and value added processes. Further advantages of a small-scale manufacturer are the increased flexibility and reactivity and the ability to converse with the whole supply chain. 2) Lean manufacturing approach Lean manufacturing ensures waste is reduced and value created for the customer. In an increasingly competitive market, CMO’s that continually adopt lean manufacturing concepts are better positioned to deliver. Presspart Nemo’s recent turnkey manufacturing project highlights how the manufacture of a drug delivery device within a lean environment can ensure the product is fit for purpose and meets client expectations for design for manufacture, cost, timing and overall value. 3) Regulatory landscape (quality,compliance) A major concern to any pharmaceutical company considering outsourcing is the quality and compliance standards of the CMO. Compliance with ISO 13485:2003, ISO 9001:2008, ISO 14001:2004, ISO 15378:2006 and EU/FDA Good Manufacturing Practices (cGMP) ensures the highest standards are adopted within a CMO and ultimately provide product quality reassurance. 4) Future trends Contract manufacturing can provide a competitive advantage for many pharmaceutical, medical and healthcare companies. Companies that integrate management of CMO’s into their business model have the opportunity to reduce capital expenditure and attain greater flexibility.
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