GMP Release Testing
GMP release testing is a critical quality control process that ensures manufactured therapeutics meet predetermined specifications before release. Prolytix provides GMP release testing for clinical and commercial drug substances and drug products.
Receive your quote directly from the manufacturer.
GMP release testing involves physical, chemical, and microbiological tests to confirm that manufactured therapeutics meet predefined specifications. Prolytix performs GMP release testing on bulk, final product, and in‑process materials.
Testing is conducted in a fully compliant, FDA‑inspected facility using validated analytical methods and predefined GMP release testing protocols.
These services support product quality and regulatory compliance from early clinical development through commercial release.
Brochures
Process development, analytical development, and GMP testing and release services
Explore the analytical and bioanalytical services Prolytix provides to support large molecule drug discovery and development, from product characterization through GMP release. Capabilities include analytical method development, critical quality attribute testing, process development, stability testing, and bioanalytical assays such as pharmacokinetics, anti-drug antibody, neutralizing antibody, potency, and thrombin generation assays. Prolytix also offers GMP-compliant release testing and lifecycle management of critical reagents.
Resource details:
Resource type: Product brochure
Page count: 2
Read time: 3 mins
Move beyond static validation with lifecycle bioassay management
Wednesday, July 29 at 16:00 BST | 17:00 CEST | 11:00 EDT | 08:00 PDT
Bioassays play a critical role in biologics development, supporting decisions across assay development, validation, CMC strategy, regulatory readiness, and long-term product lifecycle management. However, as biologics programs become more complex and regulatory expectations continue to evolve, traditional one-time validation approaches may no longer provide the flexibility or confidence required to maintain strong assay performance over time.
In this SelectScience® webinar, Dr. Ryan Dorfman, Chief Operating Officer at Prolytix, will explore the industry shift toward lifecycle bioassay strategies and why organizations are moving beyond static validation as the endpoint.
Drawing on more than 25 years of experience across the biopharmaceutical, diagnostics, and analytical testing industries, Dorfman will discuss the ongoing challenges of one-time validation, how regulatory expectations are evolving, and what teams should consider when building a practical roadmap for lifecycle bioassay management.
The session will conclude with a live Q&A featuring additional Prolytix experts Matthew Whelihan, Ph.D., Vera Bretton, and Richard Pouliot, bringing perspectives from R&D, bioanalytical assay development, GMP testing, and quality control.
Attend this webinar and gain insight into how lifecycle strategies can support stronger bioassays, improved regulatory readiness, and more consistent decision-making across biologics development programs.
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Webinar details
- Cost: Free to attend
- Location: Online
- Duration: 60 minutes
Registration is required to secure your place. If you register but can’t attend live, you will receive a link to the on‑demand recording once it becomes available.
