Symyx Biopharmaceutical Product Development for Quick Time-to-Market

Symyx is a contract development and manufacturing organisation (CDMO) delivering biopharmaceutical product development with highly optimised and robust formulations.

The company’s services offer a fast, reliable route to clinical trials. It has more than a decade of experience working with some of the smallest biotechnology start-ups and largest pharmaceutical companies.

Symyx combines formulation expertise, high-productivity research technology and current good manufacturing practice (cGMP) manufacturing capability in a single facility.

Biopharmaceutical product development

Symyx uses its expertise in formulation science, high-productivity research and biopharmaceutical product development to solve complex formulation problems ranging from proteins to peptides to antibodies. We develop highly optimized and robust formulations, so that clinical trials test the efficacy of the drug, not the limitations of the formulation.

Pharmaceutical development using parallel experimentation technology

Symyx utilizes microscale, parallel experimentation technology to quickly deliver information on our clients’ small-molecule candidates. Symyx scientists deliver critical solubility and solid-form selection information using microgram amounts of API, investigate a broad range of conditions for comprehensive accelerated stress testing and compatibility studies, and rapidly identify key process parameters for route selection and process optimization using array-based studies.

CGMP fill and finish manufacturing

Symyx integrates formulation development and CGMP fill and finish to enable 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.

Biological and chemical process development

Symyx can help you quickly identify and optimize key process conditions and parameters to speed and ensure successful development.

Biological:

• Clinical manufacturing process: develop a scalable formulation process to take laboratory methods to clinical production
• Lyophilization scale-up: ensure the method piloted in the laboratory scales up to clinical manufacturing

Chemical:

• Array-based experimentation: investigate a broad parameter space for route selection and process development for catalytic and other organic transformations
• Crystallization development: identify key organic solvents

Liquid, solid and lyophilized formulation studies

Optimize liquid, solid and lyophilized formulations for improved delivery, and investigate the effect of excipients on drug substance and other parameters.

Biological:

• Formulation development: broadly screen surfactants, pH, tonicity modifiers, bulking agents and other variables and optimize accordingly
• Long-term stability studies: two months to multi-year
• 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

Chemical:

• Forced degradation: identify conditions that cause API degradation in liquid and solid formulations
• API compatibility: identify incompatible excipients and drug products

Preformulation molecular studies

Investigate the physical and biological properties of a molecule, identify key stresses and degradation products, create stability-indicating assays and select the feasible formulation for early clinical trials.

Biological:

• Physical characterization: structure, thermal denaturation, solubility, viscosity
• Stability indicating assays and stress testing: array of orthogonal physical and chemical methods to identify degradation products
• Clinical formulation selection: liquid or lyophilized

Chemical:

• Liquid formulation: solubility and stability over a range of pH, excipients (PEGs, Tweens, etc.) and biosimulated fluids
• Solid-form selection: identify new polymorphs, optimal counter-ions for salt selection and optimal organics for co-crystallization

Clinical GMP fill and finish manufacturing

Deliver liquid and lyophilized drug product in quantities suitable for preclinical and early clinical supply.

• 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: a wide range of in-house and contracted analytics