Small molecule drugs - infrastructure and expertise
The development and production of small molecule drugs requires diverse expertise, tailored infrastructure and a structured approach to selecting and optimising the best drug candidates. Early combination of biological evaluation with chemical synthesis and structure optimisation is crucial. Later stages ensure formulation, administration and efficacy of the drug in the body. In addition, it's essential to develop processes for industrial-scale production in compliance with regulations.
The scientific process from identifying the active substance to a finished clinical product is typically iterative, requiring interdisciplinary collaboration for optimal problem-solving and success. With the advent of digital technologies, AI/ML hybrid modeling can streamline chemical synthesis method design- and process development.
Oligonucleotide drugs have been on the market since the late 1990s, but interest in them has recently exploded, with mRNA vaccines being a current example. The building blocks of these drugs, modified oligonucleotide bases, are designed and produced in a similar manner to chemical drugs. There are significant opportunities here to develop new customized drugs in a very efficient manner.
RISE supports throughout the process
Drug development spans from early discovery phases to late-stage development and commercial products, encompassing development, pharmaceutical production, and documentation according to quality and regulatory requirements.
At RISE, we have expertise across the entire chain. We can assist with process development, analysis (GMP/GLP), formulation, and production (GMP) of pharmaceutical products for clinical trials. We can test and assess the potential risks and toxicity of drug candidates and ensure that substances meet the safety margins required for market approval.
We are experienced in chemical process development, scale-up, synthesis, and reformulation of drugs with sometimes high chemical complexity and challenging physicochemical properties, from both small and large company perspectives.
Examples of expertise and infrastructure that can be tailored to the customer's needs
- Development strategy and checklist for supporting drug projects in the preclinical phase
- Synthesis route development and process design
- Conjugation chemistry and customized building blocks
- Customized oligonucleotides
- Advanced solid-phase analysis and crystallization
- Safety management of powders, high-potency intermediates, and API
- Analytical development and quality control
- Preclinical safety studies, including GLP tox, bioanalysis, and pharmacokinetics
- In vivo pharmacological and disease models can be set up upon request
- Broad expertise and technology base for formulation development, including advanced formulations (nano- micro-), tailored release, delivery, absorption, and capsule machine
- Process development and GMP production of API and IMP for clinical development
- Regulatory CMC management system (including QC and QA) for API and IMP
The need for new small molecule drugs will persist for the foreseeable future. Chemical drugs offer numerous advantages, such as improved CNS bioavailability, lower risk of immunological side effects, patient-friendly administration methods, and lower manufacturing costs compared to many biological drugs.
Additionally, stricter EU regulations demand the development of safe, effective, and environmentally friendly high-quality drugs. This necessitates new methods and approaches, including leveraging the possibilities of digitalization, to intensify production processes and develop sustainable and eco-friendly pharmaceuticals. This transition and development are areas in which we at RISE are deeply involved and can offer our customers and partners.
Contact us for further dialogue
Want to discuss your specific challenges in chemical drugs? Get in touch!
