Alcami to Expand Laboratory and Sterile Manufacturing Support with In-House Filter Validation

Filter validation can become a bottleneck in sterile drug manufacturing when third-party testing queues extend for months. For pharmaceutical and biotech teams coordinating technology transfer and fill-finish, that uncertainty adds complexity to an already demanding schedule. Alcami is preparing to introduce in-house filter validation, bringing a critical activity into the same organization supporting your manufacturing program. Once available, the capability will reduce reliance on external filter validation providers and enable closer coordination between laboratory testing and manufacturing planning. It will support Alcami's sterile manufacturing clients and will also be available as a standalone laboratory service.

Why filter validation matters

For products that rely on sterilizing filtration before aseptic filling, filter validation is a regulatory requirement, and filter performance is a critical part of the manufacturing process. Validation evaluates the selected filter's suitability for the product and process, including its ability to retain a bacterial challenge under relevant conditions.

This is particularly relevant to sensitive formulations, including certain biologic therapeutics destined for vials or prefilled syringes. Addressing filter validation early helps teams account for the work as they plan their path to manufacturing.

What the capability includes

Alcami will bring together microbiological testing and existing extractables and leachables expertise to support comprehensive filter validation programs, including:

• Bacterial retention
• Compatibility
• Extractables and Leachable
• Filter integrity

Bacterial retention and filter integrity testing

Bacterial retention testing at our Research Triangle Park laboratory evaluates the filter's ability to retain a bacterial challenge. Testing uses Brevundimonas diminuta, a small bacterium commonly used for this purpose. Filter integrity testing is also performed to assess the filter's physical integrity following the challenge.

Extractables and leachables support

The filter is one of the highest risk manufacturing components for leachable compound risk, due to its large surface area and exposure to the entire batch. Our Wilmington laboratory provides complementary extractables and leachables support, including evaluation of substances that may leach from the filter into the product during filtration. These activities ensure the filter is not generating patient risk though addition of unknown compounds to the final drug product.

The advantage of bringing validation in-house

When filter validation is managed separately from manufacturing, sponsors must coordinate an additional provider's scope and schedule. Long external queues can make that coordination more difficult, particularly as manufacturing milestones approach.

With filter validation available within Alcami, teams can discuss testing needs alongside formulation development, technology transfer and sterile fill-finish. This creates an opportunity to align validation activities with the broader program and reduce the coordination burden associated with a separate testing provider.

The result is a more integrated approach to preparing for sterile manufacturing, with laboratory and manufacturing capabilities available through one partner.

Discuss your filter validation needs

Whether you are planning a technology transfer or preparing for an upcoming sterile fill-finish program, Alcami can help you evaluate how filter validation fits into your project scope and timeline.