GXP

Practical Considerations for Demonstrating Drug Substance Uniformity for Biological Products | IVT

Selection and sizing of the filter Materials of construction for the DS containers and tubing for transfers Filtration equipment procedures Filter preparation to reduce extractable and leachable components  Container-closure integrity.  One aspect that must not be overlooked is the DS uniformity (or homogeneity). When designing validation studies, it is also important to consider the stringent regulatory expectations for ensuring batch uniformity and integrity of drug products (1). The DS may be filtered into single or multiple vessels. In the former case (single agitated vessel),...

This content is only available to IVT members.
Get help maintaining your knowledge in Acceptance Criteria. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.