Joe Newcome
Joe Newcome is Vice President of Analytical Sciences at Minaris Advanced Testing, where he leads analytical development, validation, and quality strategies supporting biologics and cell and gene therapy programs from early development through commercialization. With more than 20 years of experience in analytical sciences, quality control, and GMP testing, Joe has worked across a broad range of advanced therapies, including viral vectors, cell therapies, vaccines, and other biologics. His expertise spans potency assay development, biosafety testing, method qualification and validation, and regulatory-compliant analytical strategies. Throughout his career, Joe has supported numerous clinical and commercial programs, helping sponsors navigate increasingly complex analytical and regulatory requirements. He holds a Master of Science in Cell Biology and Biotechnology from the University of the Sciences in Philadelphia.
Company:Minaris
Minaris Advanced Testing is Minaris' dedicated biologics safety and analytical testing business, providing GMP testing services that support the development, manufacture, and commercialization of advanced therapies and biologics. Working with biotechnology, pharmaceutical, and cell and gene therapy developers worldwide, the company helps ensure the safety, quality, and regulatory readiness of products throughout development and commercial manufacturing, with the ultimate goal of helping innovative therapies reach patients.
The company offers comprehensive analytical, biosafety, and quality control testing across a broad range of modalities, including cell and gene therapies, viral vectors, biologics, vaccines, and other advanced therapeutics. Its capabilities include lot release testing, product characterization, method development, qualification and validation, stability testing, microbiology, molecular biology, virology, and regulatory support. As therapies become increasingly complex, Minaris Advanced Testing develops product-specific analytical strategies that help sponsors meet evolving regulatory expectations while advancing their programs efficiently.
With decades of scientific and regulatory experience, Minaris Advanced Testing supports customers from early development through commercialization. Its scientists understand that analytical testing is more than a regulatory requirement. It provides the critical data needed to demonstrate product safety, quality, potency, and consistency.
The company is particularly recognized for its integrated testing capabilities, supporting customers from analytical development through GMP lot release testing. This approach helps reduce complexity, maintain continuity throughout development, and generate the data required for regulatory submissions and commercial product release. As part of Minaris, customers also have access to integrated manufacturing expertise through Minaris Advanced Therapies when broader development support is needed for cell and gene therapies
As emerging modalities such as in vivo CAR-T and next-generation gene therapies continue to evolve, Minaris Advanced Testing is expanding its capabilities to meet new scientific and regulatory demands. By combining specialized expertise, global GMP testing infrastructure, and a commitment to quality, the company helps developers bring safe, effective therapies to patients with confidence.
