Custom Manifolds for ATMP Manufacturing: What You Need to Know Before You Order

Advanced Therapy Medicinal Products (ATMPs) demand precision and sterility at every stage of manufacturing. One often overlooked but critical component is the custom single-use manifold. Get this wrong, and you risk batch failure, compliance issues, or costly redesigns.

Here’s what you need to know before placing your next order:

1. Map Your Process Flow First A well-designed manifold starts with understanding your process. Are you feeding a bioreactor? Managing cell harvest? Preparing for fill-finish? Mapping out your flow will help avoid dead legs, pooling, or pressure issues later.

2. Select Materials Based on Function and Compatibility Consider temperature resistance, sterility method (gamma or EO), chemical compatibility, and extractables/leachables. Not all tubing and connectors behave the same.

3. Don’t Overcomplicate It Custom doesn’t mean complex. Simple, modular assemblies are easier to validate, sterilize, and scale. Avoid unnecessary components unless functionally essential.

4. Plan for Scalability If you’re in early clinical stages, make sure the manifold design can be scaled without major changes. BioProcess Solutions can help you think ahead so your clinical setup won’t hold you back at commercial scale.

5. Document Everything Ensure you get CoAs, sterilization certificates, and other related documentation with every order. This saves time during audits and tech transfers.

Need help designing or validating a manifold for your ATMP process? We offer free design consultations and rapid prototyping.

Contact our team at info@intobioprocess.com