Proven Large Molecule Drug Product Development
With a science-driven approach and modern equipment, we support a wide range of large molecule drugs, including proteins, peptides, monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), and microbiome or other bacterially derived products.
We offer streamlined drug development services to support your programs from candidate selection through commercialization. We are your integrated services partner, providing capabilities that include preformulation screening, formulation, and process development through clinical supply manufacturing and beyond.
Driving Forward Biotherapeutic Selection
Conduct complete analytical characterization to identify the qualities and behaviors that will shape your drug substance and drug product development. Our team characterizes your biologics’ purity and identity, posttranslational modifications, protein aggregation potential, and other parenteral quality attributes.
Gain targeted insights and support lead selection and optimization with our custom bioanalysis services. We offer comprehensive quantitative bioanalytical services across different drug development stages in parallel with our other analytical, formulation development, and manufacturing capabilities.
Biologics Development & Drug Product Optimization
Utilize stage-appropriate analytical methods to address well-defined parameters and prepare for subsequent activities in your biologic drug product development. Our experts provide analytical development techniques and validation to inform downstream experiments.
Design and optimize your product’s formulation across various stages of the development process. We provide comprehensive support, from early developability assessments and preformulation to the optimization of dosage form and delivery.
Make a smooth transition into pivotal clinical phases with our process development services. With numerous variables at play, our integrated lab network leverages a dynamic, responsive approach to unforeseen challenges. We carefully characterize the manufacturing processes for scale-up and robustness, then transfer these to one of our GMP facilities.
Overcome complexity and variability in biologics manufacturing of clinical trial material by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your available material and bringing your compound to market faster while meeting all current quality, health, and safety standards.
Safeguard your drug product’s quality and delivery to the end user with our trusted clinical packaging, labeling, and kitting services. With our assortment of advanced technologies and manual capabilities, your project seamlessly transitions into the clinic. We treat each product with the time and attention it deserves to achieve the highest quality possible, no matter the scale.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.