HALIX offers complementary services for clients when managing the product life cycle of their biopharmaceutical products.
Regulations specify that pharmaceutical raw materials, intermediates and final products need to be tested to ensure their identity, purity and potency meet the required specifications. This means several tests and assays may need to be performed as part of a pharmaceutical GMP manufacturing project.
For example, cell banks and virus seeds need to be qualified, raw materials need to be tested according to relevant pharmacopoeia, intermediates need to meet exacting specification and final products need to be rigorously tested for safely and potency.
HALIX performs in process testing and the most critical testing in-house, using state of the art methods and highly trained personnel. For additional specific testing requirements we have built up an audited network of partnerships with world class quality control laboratories. In this way we can ensure the delivery of a comprehensive and fit for purpose bill of testing.
HALIX can assist you in designing your quality control strategy, offering the opinions of our experts to help you to create a bill of testing (BoT) for your product and process.
Our project managers are there to ensure timely delivery of test results as part of the manufacturing cycle, so that release of products meets pre-agreed timelines.
HALIX Full Service Offering.
When outsourcing to HALIX you get a full service package of expert development activities, high quality GMP manufacturing services and a comprehensive QC package. Our in-company qualified persons can release your product for use in a clinical trial.
Our experts and partners can offer their advice and opinion in case of open questions concerning the required tests and assays for your product. We can support your product with the right validation level for various preclinical and clinical phases.
Contact our team of experts
Please contact our team to learn more about how we can support you, or to discuss your requirements.