Life Sciences

Complete Elemental Testing for Trace Metals & Impurities Comply with quality control standards by leveraging our analytical services to monitor label-claims and demonstrate control of trace-level elemental impurities. Our team provides full-service GMP laboratory capabilities to assess the levels of elemental impurities in your raw materials, in-process formulations, and finished pharmaceutical or medical device products. […]

Chemical Characterization to Ensure Product Safety Utilize our comprehensive approach towards chemical characterization to identify extractables and leachables. These compounds may be organic or inorganic in nature, typically from devices which contain additives. These additives include materials such as lubricants, accelerators, monomers, and high molecular weight oligomers from incomplete polymerization, and residual solvents. Extractables may

Ensure Safe & Effective Manufacturing with Reference Standards We support the development and application of reference standards in a manner that considers the unique requirements of your materials and processes. These standards play a foundational role in determining quantitative data, qualitative data, and calibration, which are critical to achieving scientifically valid results. Our team is

Reliable Stability Studies & Shelf-Life Testing Enhance the shelf life of your drug product and ensure regulatory compliance with our stability testing and storage services. Our team manages state-of-the-art laboratories equipped with stability storage chambers mapped and continuously monitored using a validated, continuous monitoring system. These facilities fulfill requirements for stability studies, shelf-life testing, and

Comprehensive Finished Product Testing and Batch Release Services Ensure your finished product meets critical specifications consistently. Our team is dedicated to verifying the production of your drug product, maintaining its intended use, quality, and performance characteristics. Despite the increasing complexity of therapeutic molecules, derived from diverse synthesis processes, we possess the expertise and infrastructure to

Ensure Your Product’s Quality with Raw Materials Testing Safeguard your drug product quality from setbacks or repercussions, such as manufacturing delays and recalls, with trusted raw materials data. Our raw materials quality control testing demonstrates the identity, purity, and quality of excipients and active pharmaceutical ingredients used in finished product manufacturing. In addition, our experienced

Delivering Insights & Innovation Tailored to Your Program Support the analytical, formulation, and process development of your novel molecules with our custom research and development services. Scientific advances continue to spur the creation of innovative molecules and approaches for the treatment of diseases, and our team is ready to help your innovative drug programs success,

Novel Compound Characterization Testing Understand your targeted therapeutic and prepare your nonstandard program as it advances through discovery and development with product characterization testing. Novel molecules, such as antibody-drug conjugates (ADCs), polymer-drug conjugates, and other combinations, represent a growing market segment. Our team applies our significant experience and capabilities in developing small molecules, biologics, and

Clinical Supply Manufacturing Tailored to Your Needs Overcome complexity and variability in manufacturing clinical trial materials for nucleic acid therapeutics by partnering with our highly experienced team in state-of-the-art facilities. Our flexible solutions prioritize preserving materials and bringing your compound to market faster while meeting all current quality, health, and safety standards. Leverage our extensive

Advanced Nucleic Acid Process Development Producing satisfactory nucleic acid therapeutics is rapidly evolving, often challenged by molecular stability and technical complexity. Our expert team and state-of-the-art facilities offer specialized support and innovative approaches. We have experience developing novel processes outside the common platform processes used by established contract manufacturing organizations (CMOs) making oligonucleotides by solid