Commercialising the Supply Chain

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Commercialising the Supply Chain

• Ian Machan
• Machan Consulting

machan consulting www.machan.co.uk
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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?
• Im 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
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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
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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
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Non-Healthcare Regulations

• Health and Safety Executive
• Environmental
• Waste disposal and effluent control
• Packaging directives
• Working Time Directive

machan consulting www.machan.co.uk
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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
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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
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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
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Thank you

• Ian Machan
• Machan Consulting
• Contact 44 (0) 7780 646142
• E-mail ian_at_machan.co.uk

machan consulting www.machan.co.uk