We provide flexible, custom biologic CDMO solutions based on deep expertise and risk management to optimize your speed and help you reach your key milestones.
Whether you’re preparing for clinic or manufacturing a life-saving therapeutic biologic in multiple countries, protecting your investment with cGMP-compliant testing is critical.
As a product innovator and CDMO with 20+ years of experience, we have produced more than 500 batches of virus within the last decade to support gene therapy development from clinical stages through to commercialization.
When you have a partner with a strong track record and reputable relationships with regulators, you can feel more confident about regulatory process and focus on your drug development.
Our dedicated experts work with you from start to finish to meet your unique needs. And we stay at the forefront of regulatory guidance and share our knowledge so you’re the first to know about new developments.
“The BioReliance® team made the whole regulatory process really easy for us. They kept us informed all the way through.”
BioReliance® End-to-End Solutions is a full-service biologic CDMO offering deep expertise and flexible, custom solutions at all stages of the development and manufacturing process. We’ll balance risk to optimize your speed to market without ever compromising on quality or safety, and support all aspects of your regulatory compliance.
Whatever your development challenge, our experts can design custom solutions to manage risk.
Whatever stage of the pharma or biopharma development process you’re in, our leading cGMP-compliant testing services can help you to get your therapeutic from discovery to release as quickly as possible.
Analyzing data from multiple vendors can take up valuable time. Our product characterization teams make things easy by synthesizing data from multiple analytical methods into one report, streamlining your data to make it more actionable.
Our off-the-shelf mAb assay packages are designed to provide actionable data quicker, for better decision-making. We’ll discuss details with you and assign a dedicated project manager to ensure we meet your unique needs. See how a partnership with us can help bring your biotherapy to life.
We provide a complete range of viral and gene therapy CDMO services based on more than 20 years of experience taking genetic products from development to commercialization. Our comprehensive offering spans clinical and commercial manufacturing, process development, cell, and viral banking, tech transfer, fill finish, secure biostorage, and viral vector testing and manufacturing.
As a full-service biologics CDMO with deep expertise across all stages of biologic development and manufacturing, we pride ourselves on working relationships built around your specific needs. We offer flexible, custom solutions for mammalian cell line and process development, media and feed screening, master cell banking, scale-up, and GMP commercial drug substance manufacturing. With 30+ years of experience in process development and 25 years in GMP manufacturing, we’ve helped to bring more than 260 biologics to market.
Biologics Testing, Product Characterization, and Genetic Toxicology
We deliver brilliant biosafety testing experiences through the entire drug lifecycle. Our comprehensive product characterization program reveals the true identity of your molecule through every phase of development, ensuring your biotherapy’s safety, purity and potency.
Explore our pharma and biopharma testing services in more depth:
Pharma Testing Services
Biopharma Testing Services
Success needs powerful
We build partnerships that deliver excellence and flexibility from start to finish, so you can get your therapies to the patients who need them.