2004D-0118 - International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E)
FDA Comment Number : EC2
Submitter : Mr. Thomas Hogan Date & Time: 06/10/2004 04:06:13
Organization : Johnson
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
19 May 2004

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rm. 1061
Rockville, Maryland 20852

RE: Draft Guidance - Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
[Docket No. 2004D-0118]

Dear Sir or Madam:

Johnson & Johnson is pleased to have the opportunity to comment on the ICH Q5E - Step 2 document on "Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process".

We only have one significant comment related to the definition of comparability and the reference to the terminology of 'highly similar' throughout the document.

The term 'highly similar' can not be quantified/qualified in the comparability exercise, since the claim of comparability is based on the assessment of the product profile (pre- and post-change) in terms of quality, safety and efficacy. Comparability for a given product is the exercise which will demonstrate that pre- and post-change products have a 'similar profile' in terms of quality, safety and efficacy. This use of the term 'similar profile' is also consistent with the definition of comparability included in Section 1.4 of the CPMP Guidance document on Comparability - Quality Issues (CPMP/BWP 3207/00/rev1, Dec 11, 2003).

Therefore, Johnson & Johnson recommends to revise the definition of comparability used in the glossary and propose to use an alternative wording for 'highly similar' which would read as follows : 'product with a similar profile'. Additionally, throughout the document where the term 'highly similar' is used, it is recommended that the term be replaced with 'similar profile'.

We appreciate the Agency's consideration or our comments and are committed to collaborating with the Agency to developing improved versions of the guideline.

Should you have any questions, please do not hesitate to contact me.

Sincerely,

Tom Hogan
Senior Director
Worldwide Regulatory Affairs
Chemistry, Manufacturing & Controls
Centocor Inc.
200 Great Valley Parkway - Building 5
Malvern, PA 19355-1307
Tel: 610 240-8163
Fax: 610 240-4009
E-mail: thogan4@cntus.jnj.com