Life Sciences

Reliable Fill-Finish Manufacturing of Biologic Clinical Supplies Manufacture your GMP clinical supplies with confidence when you partner with our team. No matter your modality, be it a protein, peptide, vaccine, or mAbs, our team has the expertise, infrastructure, and resources to fulfill your clinical supply needs. We offer solutions customized to your current progress, whether […]

Enteric Coating Process Development Control the release of your biologic by coating the intermediate drug product with protective layers called enteric coating. These coatings inhibit the release of your biotherapeutic in low pH environments where they are vulnerable to degradation and agglomeration. Our team identifies the appropriate enteric coating for your biologic and prepares your

Purification Processes & UF/DF Prepare your biologic for advancement with downstream ultra filtration (UF) and diafiltration (DF) purification processes. Whether your project requires a one-off buffer exchange to support early-stage formulation development or a full-scale process development endeavor intended for transfer to GMP facilities, our team prepares your manufacturing and fill finish processes to optimize

Injectable Formulation Development Developing injectable formulations presents challenges in ensuring biologic stability at therapeutic doses and seamless compatibility with devices and administration. To overcome these obstacles, we prioritize safeguarding your biotherapeutics stability and solubility, creating a product that best serves your patient population and market opportunity. Achieve targeted drug delivery with our team’s expertise in

In-Use Clinical Compatibility Test the compatibility of your materials and equipment with your biotherapeutic to ensure dosing and limit immunogenicity concerns prior to patient administration. Our team addresses many factors that impact in-use compatibility, such as varying materials used in IV bags, tubing, syringes, and filters. Other factors, such as chemical composition and manufacturing processes,

Enhanced Solutions & Suspensions Formulations Elevate your biological formulation with the optimal solution or suspension dosage forms for your product. We know first-hand the importance of amplifying a compound’s potential, researching every avenue for optimal responses, and delivering a gentler dosing experience your end customers deserve. Even if your biologic or large molecule is difficult

Structural Assessments and Proactive Aggregation Monitoring During early drug development, it is critical to determine if your biologic protein is prone to self-association. Protein aggregation can cause activity loss of the drug substance and post immunogenicity risks on administration, threatening your drug development process. Formulation, processing, and contact material changes have the potential to trigger

Assess Your Biologic’s Stability with Purity Testing Gain lasting confidence in your drug’s composition with identity testing in the form of separation and quantitation – a trusted purity test backed by chromatographic, electrophoretic, and spectroscopic instrumentation. These analytical characterization assessments are valuable for contributing to a larger formulation or process endeavor and acting as a

Trusted Clinical Supplies for Gels, Creams, & Ointments Our integrated product development and manufacturing teams have the speed, flexibility, and eye for quality needed to advance your semi solid dosage form successfully through clinical phases. Focused on providing a seamless transition from research to clinical supply manufacturing and packaging, our experts leverage their depth of

Clinical Manufacturing of Pharmaceutical Liquid Suspensions & Solutions Clinical stage drug development programs require a unique mix of speed, flexibility, and quality. Our integrated product development and manufacturing teams are structured to help you seamlessly transition from research and development to clinical supplies manufacturing and packaging. Our facilities and equipment meet international quality standards and