Symeres has long-established expertise in non-GMP scale-up for IND-enabling studies, ensuring that our clients can confidently navigate the transition from laboratory-scale synthesis to clinical phases while minimizing costs and risks.
The well-documented processes we provide significantly reduce the inherent risks associated with scaling up of production. Our team of experienced chemists specializes in process optimization, delivering efficient and effective non-GMP scale-up procedures.
During non-GMP scale-up, we focus on a series of key parameters in the evolution from drug discovery to development, notably encompassing the development of the most suitable solid form, analytical packages, and batch records. Our systematic approach guarantees that impurity profiles are carefully monitored and controlled, mitigating potential regulatory concerns, and securing the safety of the final API. At this stage, time and budget are critical, and scale-up optimization necessitates adherence to a phase-appropriate strategy with quality and safety standards without compromise, a principle we consistently uphold.
Non-GMP scale-up forms part of a bigger picture of IND-enabling activities, and at Symeres we can also build robust packages around solid-state chemistry, formulation, and ADME-Tox. These can be combined in a tailored package as part of our developability roadmap.
Our commitment to adhering to industry regulations and guidelines, coupled with our comprehensive documentation practices, provides clients with the confidence that their non-GMP scale-up activities will meet regulatory requirements and facilitate a smooth regulatory submission process and form the basis for subsequent GMP manufacturing of drug substances and drug products.
By leveraging our expertise, clients can expedite the development timeline and accelerate progression to later clinical phases.
Discover Exemplify
We deliver a number of services in partnership with Exemplify BioPharma, a global Partnership Research Organization (PRO) offering end-to-end CMC solutions under one roof.
Exemplify offers:
- Integrated project management across Process Chemistry, Analytical Chemistry, and Formulation Development
- Expert oversight on CRO/CMO selection, contracting, and management
- Comprehensive support with CMC regulatory submissions (IND, IMPD, NDA, MAA)
- Full Quality Assurance and compliance sign-off
- Efficient timeline and budget management
Their newly expanded Formulation Suite also opens the door to enhanced formulation capabilities, strengthening support from early development through to commercialization.
