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Commercialising the Supply Chain

Commercialising the Supply Chain. Ian Machan Machan Consulting. machan consulting www.machan.co.uk. Introduction. Provide an overview of a number of topics Feedback session to identify those important to you Why consider how to Supply your product? Can it be supplied in large quantities?

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Commercialising the Supply Chain

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  1. Commercialising the Supply Chain Ian Machan Machan Consulting machan consulting www.machan.co.uk

  2. Introduction • Provide an overview of a number of topics • Feedback session to identify those important to you • Why consider how to Supply your product? • Can it be supplied in large quantities? • Can you and you investors make a profit with it? • “I’m going to sell the IP, why bother?” machan consulting www.machan.co.uk

  3. Scaling up from Lab to production • Laboratory experiments to one tenth, and then full size processing. Is it scalable? • Do you use the same process, but bigger? • Advanced thinkers in the industry are viewing this as a key competitive advantage area. Crossing over ideas from other industries and using more science machan consulting www.machan.co.uk

  4. Deciding to make or buy • A decision based on: • Fundamentals, such as science, technology or IP • Practicalities, such as the scale of the process • Fixed cost/variable cost implications • Location of your knowledge, market, raw materials • Where in the world? machan consulting www.machan.co.uk

  5. Deciding on a facility • A facility that allows scale up • A facility that will meet Regulatory inspection • A facility that is affordable, or acceptable to funding stakeholders • A facility that can grow • A facility where 50% + will be support! machan consulting www.machan.co.uk

  6. Regulatory and Quality Systems • Regulatory Bodies: MHRA, EMEA, FDA, ICH, Japan • What they require of your product • What they require of your processes • What they require of your Supply • What they require of your people e.g. QPs machan consulting www.machan.co.uk

  7. Validation of processes and supplies • Validation is about proving that processes, equipment, materials and supplies do what you say they should do • Creating a Master Validation Plan • Assistance from the ISPE Biopharmaceutical Baseline guide machan consulting www.machan.co.uk

  8. Production process understanding and optimisation • Understanding your process on a large scale basis • Optimising your process so that you succeed with goods right first time • Inter and intra batch process consistency • Using Process Analytical Technology (PAT) or final product testing machan consulting www.machan.co.uk

  9. Recruiting, managing and supervising a factory • In a study of US Biopharma manufacturers, 90% of the people employed were in production compared with 7% in the R and D function* • Frequent failures identified by Inspections are insufficient skills, experience, and supervision of production people • Recent Employee legislation has intensified * Source : Windows on the workplace 1997 machan consulting www.machan.co.uk

  10. Maintenance of process and utility equipment • To provide a consistent process, the equipment must: • Remain in calibration • Operate as validated, with change controls • Be cleanable and cleaned • Half of the equipment may be support/non-process kit machan consulting www.machan.co.uk

  11. Product formulation and pack design • Why worry about it? • Marketing people will want tablets • Producing a Pack design that appeals to Physicians and/or the patient • Distribution channels and marketing channels • Conditions of transport and shelf life machan consulting www.machan.co.uk

  12. Business Resource Planning • Planning how to align your Business resources to the Market demand • Based around forecasting/collecting demand • Based around planning your supply • Matching the two, short and long term • Reacting in a controlled way to changes in either demand or supply machan consulting www.machan.co.uk

  13. Non-Healthcare Regulations • Health and Safety Executive • Environmental • Waste disposal and effluent control • Packaging directives • Working Time Directive machan consulting www.machan.co.uk

  14. Technology Transfer • Moving a product from a manufacturing site is neither straightforward nor quick • Forward planning by registering two sites is one option • Crossing over methods, processes and systems requires planning, but can be lucrative • Planning on transfer as a business strategy machan consulting www.machan.co.uk

  15. IT Systems • Looking forward, paper based systems are dead • Electronic signatures on Electronic Batch Records • Electronic drug submissions through the CTD • Statistical Process control on key processes • Electronic support systems machan consulting www.machan.co.uk

  16. Contracting Supplies and production • Buying the right materials • Buying in the quantities you now need is different • Ensuring quality of supplies • Ensuring continuity of supply: single or dual sourcing • Ensuring a competitive cost: Global sourcing machan consulting www.machan.co.uk

  17. Thank you Ian Machan Machan Consulting Contact: +44 (0) 7780 646142 E-mail ian@machan.co.uk machan consulting www.machan.co.uk

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