Robust Analytical Support for Manufacturing and Release
Advancing complex biologics requires more than standard testing. It demands analytical strategies that align with your therapy, your phase, and your regulatory pathway. Our in-house, GMP-compliant testing services are designed to help you reduce time to release, maintain product integrity, and scale with confidence.
What you can expect:
- Complex Therapy Specialized Testing: These therapies are often complex and require specialized analytical methods to ensure safety, efficacy, and quality.
- Regulatory Guidance: Regulatory agencies have specific requirements for testing and characterization therapies.
- Ensure Product Quality: These services help ensure that the final product meets the required standards for safety and efficacy.
Testing Modalities
Bringing advanced therapies to market demands testing strategies built for your product’s complexity. Whether you are working with monoclonal antibodies, viral vectors, vaccines, or cell therapies, our modality-specific services help you meet safety, efficacy, and regulatory expectations at every stage of development.
Viral Vector Testing Services
Confidently advance gene therapies with testing tailored to the needs of viral vectors such as AAV and lentivirus. From characterization through lot release, our in-house CGMP services support consistent quality, regulatory alignment, and scalable development.
Monoclonal Antibody Production Services
Accelerate your monoclonal antibody (mAb) development with end-to-end support for discovery, cell line development, process optimization, and clinical manufacturing. Our integrated approach helps you reduce timelines, maintain quality, and advance confidently from early development to first-in-human studies.
Vaccine Testing
Design and execute vaccine studies with the flexibility and scientific rigor needed to support regulatory submissions. Our in vivo testing capabilities cover both short- and long-term challenge studies across multiple species, helping you generate the data required for confident decision-making and timely progression to the next phase.
Cell Therapy
Advance your cell therapy with testing strategies tailored to the unique needs of gene-modified and unmodified stem cell therapies, whether allogeneic or autologous. Our integrated quality control approach supports product safety, efficacy, and regulatory compliance, helping you move confidently from early development to commercialization.
Real-time, secure access to your data
Our innovative Apollo™ platform gives you secure, cloud-based, real-time access to your sample data, milestones, and documents. With it, you can submit sample submission forms, track samples, and exchange documents all in one place, ensuring accuracy and saving time.
The Future of Cell Therapies: Are You Using the Best Tools for Success?
Cell therapies are some of the most advanced modalities in modern medicine, potentially transforming outcomes for previously untreatable diseases. However, cell therapies require cutting-edge approaches to ensure their safety, efficacy, and scalability. Next Generation Sequencing (NGS) is the modern solution best suited to the complexities of developing donor-derived cell therapies, offering many advantages over traditional Polymerase Chain Reaction (PCR).
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Next Generation Sequencing for Adventitious Virus Testing
Innovative next generation sequencing approaches can detect live viral contaminants in cells, and regulatory bodies are encouraging its use as a replacement for in vivo assays.