ICH Q6B - implications for developers of … Q6B - implications for developers of biopharmaceuticals March 2012 Originally presented by GxPi on 23 November 2010 © GxPi 2012 2 Presentation

ICH Q6B - implications for developersof biopharmaceuticals

March 2012

Originally presented by GxPi on23 November 2010

© GxPi  2012  2

Presentation Overview

“A strategic overview of the considerations that any organisation should apply to its analytical test methodologies and how it is addressing the ICH guidelines. What are the risks that need to be managed? Where does the focus of effort need to be? What resources can be used to achieve the results in a smart, efficient manner? What key measures of success need to be built into the approach – time, cost, retained knowledge? The talk will also look at how the requirements to meet the guidelines evolve with the product during the development lifecycle.”

© GxPi  2012  3

GxPi Overview

“We simplify complex process and technology environments to deliver our customers’

compliance and quality goals in their regulatory framework.

We achieve this through a combination of Services and Products that transfer our expertise

to our customers”.

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ICH Guidelines

“The purpose is to make recommendationson ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.”

Source: ICH Website (www.ich.org)

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ICH Q6B

• Uniform set of international specifications for

biotechnological and biological products to support

new marketing applications

• Used to define the quality of the biological

product, not full characterisation

• To be an integral part of your GMP operations

for the production of the material

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ICH Q6B – Managing risk

What are the real risks?

• Unable to generate standards• Unacceptable variance in material

specification and quality

Which results in.......

• Repeat work required• Additional support work required

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ICH Q6B – Managing risk

• DELAY

• COST

• LOSS OF PROFIT

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ICH Q6B – Development Cycle

• What are the significant differences in the manufacturing techniques, quality and specification of material needed for pre-clinical and clinical phases?

• NONE!

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ICH Q6B – Prioritisation of effort

• Once you have isolated your material......

• The principles of GMP should be applied at all stages of the development:

• Personnel• Materials• Procedures• Operations• Management

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ICH Q6B – People

• People - The biggest impact upon the quality, consistency, repeatability and continuing improvement of the product and associated testing

• GMP culture

• GMP knowledge and experience

• GMP training and rules

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ICH Q6B – Materials

• Materials – There is little point in investing heavily

in science and techniques if starting materials are of

inferior quality....

• Proven, reliable sources of materials

• Appropriate specifications and technical agreements

• Audit, test and records

• GMP!

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ICH Q6B – Procedures

• Procedure – The need to translate the processes of

the lead development scientists into a set of GMP

instructions....

• Repeatable?

• Transferable?

• Scalable?

• A simple process or technique is no less important to

the quality of the end product

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ICH Q6B – Operations

• Operations – The operation for development and

manufacture, specification and testing of the material must be

run as a GMP process, irrespective of size

• Equipment / facility – validated and recorded?

• Methods – validated and documented?

• Batch records to support all material?

• CAPA?

• Change Control?

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ICH Q6B – Development

• Development – Providing a consistent and reliable foundation

for a new Substance / Product that enables an effective and

efficient development program

• Production / extraction process?

• Stability of material (how quickly will the standard denature /

degrade?)

• Outsource to experts where appropriate

• Don’t jump in too soon!

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ICH Q6B – Development (2)

• Development – How do we standardise a novel substance or product?

• As many batches / runs as possible

• Ensure consistency in materials, processes, controls and results

• GMP!

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ICH Q6B – Spec. development

• Good News!

• Advances in analytical technology (e.g. Mass Spec. -characterise proteins, quantify variant form) – USE THEM!

• Biological activity – may take time to identify a precise method (e.g. enzyme or binding)

• Contaminants – Host Cell Protein (HCP), host DNA, endotoxin....

• Drug product – what is the potential impact of the presentation (e.g. Syringe material)?

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ICH Q6B – Spec. Development

So where to best focus your efforts?

• Transfer of information – Development scientists to Analytical team

• Use partners and specialist service providers for testing methods. It is their day job

• Working on the consistency, repeatability and quality of the product

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ICH Q6B – Management

• The biggest risks are often the transition stages

between phases.....

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ICH Q6B – Management

• Management – There must be ownership and understanding of the entire test development process from concept to completion

• Total Quality Management – the smallest error or oversight can invalidate the test method or compromise product safety, quality or efficacy

• This is a project and requires a competent Project Manager to be assigned

• Think like a production operation, irrespective of size of the operation

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ICH Q6B – Quality

• You can’t test quality into the product at the end of

the process......

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ICH Q6B – Conclusions

• GMP processes must be applied from early stages of the product development / test method development program

• Reduce risk by using quality materials, consistency in the starting material process and having validated methods from the start

• The simple routine tasks are as important as the complicated, exciting ones.

© GxPi  2012  22

References

• GxPi website: www.gxpi.com

• Contact name: Mark Stevens

• Email: [email protected]

• Telephone: +44(0)115 924 8475

• Other useful websites:

• ICH: www.ich.org

• BIA: www.bioindustry.org

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