Getting to Clinical Trials Faster with a Better Formulation: Symyx CDMO
July 1, 2009
Symyx CDMO (contract development and manufacturing organization) provides a faster, more reliable route to clinical trials by delivering drug product manufactured with a highly optimized and robust formulation. We have over a decade of experience working with the smallest biotechnology start-ups and the largest pharmaceutical companies. Symyx combines formulation expertise, high-productivity research technology, and CGMP manufacturing capability in a single facility.
Biopharmaceutical Development and CGMP Manufacturing
Symyx has the subject-matter expertise and technologies to integrate the development and manufacturing of preclinical and clinical trial–ready formulations. We are uniquely positioned to tackle complex formulation problems in the context of specific client constraints. We ensure that when our clients take a formulation to clinical trials, they’ll be testing the efficacy of the drug candidate rather than the limitations of a formulation.
Symyx integrates formulation development and CGMP fill and finish, enabling direct transfer of liquid and lyophilized processes to early clinical manufacturing. We offer both manual and automated aseptic fills in a sterile environment that meets US and EU standards. Our facility provides in-process, release and stability testing services with a range of CGMP analytical techniques.
Partner with Symyx for …
Preliminary Formulation Studies: Investigate the physical and biological properties of a molecule, identify key stresses and degradation products, and create stability-indicating assays.
Preformulation Studies: ()
Formulation Studies: ()
Physical characterization: structure, thermal denaturation, solubility, viscosity
Stability indicating assays and stress testing: an array of orthogonal physical and chemical methods to identify degradation products
Clinical formulation selection: liquid or lyophilized
Formulation Optimization Studies: Optimize liquid and lyophilized formulations for improved delivery, and investigate the effect of excipients on drug substance and drug product that lead to the selection of a formulation for preclinical and clinical trials.
Formulation development: Broadly screen surfactants, pH, tonicity modifiers, bulking agents, and other variables and optimize accordingly.
Long-term stability studies: two months to multiple years
Drug substance compatibility: Identify potential degradants and interactions with excipients and container/closure systems.
Lyophilization cycle development: Develop a scalable process for next phase manufacturing.
Process Development: Quickly identify and optimize key process conditions and parameters to speed and ensure successful development.
Process Development: ()
Clinical manufacturing process: Develop a scalable formulation process to take laboratory methods to clinical production.
Lyophilization scale-up: Ensure the method piloted at laboratory scales to clinical manufacturing.
Clinical GMP Fill and Finish Manufacturing: Deliver liquid and lyophilized drug product in quantities suitable for preclinical and early clinical supplies.
CGMP Fill and Finish: ()
Operation flexibility: both manual and automated fills
Manufacturing requirements: meets both US and EU standards
Lyophilization: direct method transfer from development to manufacturing
Release and stability testing: wide range of in-house and contracted analytics
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