Life Sciences

Prepare Your Drug Product with Process Development Prepare your product for advancing into the clinic and beyond with our integrated approach to the drug development process. We help you develop downstream purification processes, repurification, UF/DF, compounding, and challenging formulation processes. Our approach focuses on gaining a deep molecular understanding of the API while maintaining a […]

Optimizing Biologic Formulation Development Accelerate your biological product with our comprehensive formulation development support. Partner with us for a faster, easier, and more effective drug development process. Our Design of Experiment (DOE) approach integrates everything you need for efficiency and success, including Assessing samples under accelerated stress conditions Selecting stable drug formulations with sufficient solubility

Comprehensive Analytical Testing & Development Advance your biotherapeutic entities by partnering with our team to develop stage appropriate analytical methods. We secure your downstream testing success with our precise Quality by Design (QbD) approach, in-depth understanding of macromolecule physicochemical properties, and state of the art analytical instrumentation and columns.After establishing method feasibility, our team optimizes

Complete Materials Characterization of Your Biopharmaceutical Any changes to your biotherapeutic drug development process, from the expression system to manufacturing process, impacts your product’s chemical stability, conformational stability, and resulting activities. It is important to characterize your biologic to de-risk downstream development. Utilizing state-of-the-art equipment, our experienced scientists use stage-appropriate analytical, biophysical, and compendial testing

Customized & Reliable Clinical Supply Manufacturing Advance your program with reliable, compliant clinical supplies by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your drug substance materials and bringing your compound to market faster while meeting all current quality, health, and safety standards. Leverage our extensive GMP clinical

Overcome Pharmaceutical Formulation Challenges with Specialty Technologies Specialized pharmaceutical technologies play a crucial role in formulating and developing drug products, especially when conventional methods fall short. Selecting the right technology can be challenging. Our experienced team helps you find the right tool for the job. We first assess the suitability of complex drug development approaches

Expert API Formulation Development With decades of practical formulation development experience and a keen attention to detail, we create pharmaceutical formulations that are safe and efficacious. Our development process produces optimal drug product formulations within the boundaries informed by preformulation characterization data, including solid form, solubility, stability parameters, and target pH range. Our strategies withstand

Pharmaceutical Analytical Development Accelerate your drug development program by leveraging our analytical development services. We create robust, phase-appropriate methods to address well-defined parameters and prepare for future pharmaceutical product development activities. Our experts offer techniques and validation for solubility, dissolution, stability, and solid form definition. We’re experienced in evaluating and, if necessary, redeveloping existing methods

Accelerate Preformulation Development Gain a better understanding of your molecule’s unique attributes through strategic prediction, experimentation, and measurements. Our preformulation studies characterize and analyze critical properties of your molecule to inform preclinical development. By assessing how your drug behaves under various conditions and environments you’ll be able to narrow down which candidates have greater odds

Collaborations to Innovate API Development Push the boundaries of what’s possible in drug development with support from our experienced team. Our team provides research and development capabilities tailored to your specific molecule and therapeutic applications. We leverage a network of nationwide laboratories to better understand the unique chemical, pharmaceutical, and business attributes your compounds have