Comprehensive Expertise

Our team excels in developing robust assays tailored to your specific biologics, ensuring accurate measurement of potency and purity. We utilize advanced chromatography techniques and mass spectrometry for detailed characterization, providing the insights necessary for informed decision-making.

Proven Track Record

With over 45 biologics and biosimilars developed, over 100 successful cGMP batches delivered, a commercially approved biosimilar in the U.S. and Canada, and partnerships with leading pharmaceutical and biotech companies, we have established ourselves as a trusted partner in the biologics industry.

Mammalian and Microbial Expertise

We specialize in a diverse range of biologics, including fusion proteins, monoclonal antibodies, antibody derivatives, bispecific and trispecific antibodies, antibody-drug conjugates (ADCs), enzymes, and other innovative biologics. Our extensive experience in both mammalian and microbial systems enables us to deliver high-quality solutions tailored to your specific needs.

Regulatory Compliance

Our FDA-registered facility in the U.S. and our membership in PIC/S, ensure that we adhere to the highest global standards for drug substance production. This positions us to deliver quality biologics for clinical trials worldwide.

Reliable Method Validation
We employ industry-standard protocols for method validation, guaranteeing reproducibility and compliance with regulatory requirements. Consistency across production batches is achieved through stringent quality control measures and real-time analytics during production.

Innovative Formulation Solutions

Developing stable and effective formulations is our priority. We conduct rigorous stability studies in climate-controlled chambers and leverage formulation software for predictive modeling to enhance solubility and prevent aggregation, ensuring optimal performance in clinical settings.

Tailored Delivery Systems

We design and optimize delivery systems that safeguard product integrity. We also utilize automated liquid handling systems to improve efficiency and accuracy in our processes.