Overview
Bio Clinton offers GMP, biopharma and non-GMP specialty chemical custom ingredient research and development services by generating robust, practical and cost-effective processes for the preparation of specialty chemicals, excipients, and pharmaceutical ingredients. With decades of experience in problem-solving, our wide-ranging, global R&D team is highly skilled at timely development of scalable processes that focus on simplicity, robustness, and suitability for purpose. Throughout the years, we have provided GMP, biopharma and non-GMP specialty chemical custom ingredient solutions to a vast array of industries around the world.
Capabilities
- GMP excipients and pharmaceutical intermediates
- Non-GMP specialty chemicals with extensive experience in many different types of chemistry including chlorination, alkylation, Grignard chemistry, organo-metallic chemistry, hydro fluorination, halogen exchange, polymerization, etc.
- Biopharma substances and intermediates for antiviral, cancerostatic and cardiovascular drug substances and for their key intermediates in the areas of Nucleotides, Nucleosides and their analogues.
Bio Clinton boasts comprehensive analytical capabilities including but not limited to purity testing, structural conformation, impurity identification and quantification, physical properties, stabilities, performance-based testing, comparative studies of products and raw materials. These analytical capabilities support our R&D teams as well as providing services to many well-known external partners.
Our Approach
Bio Clinton’s GMP, biopharma and non-GMP specialty chemical custom ingredient research and development services are composed of 5 main phases:
1. Initiation phase
During this phase all your specific needs for the customized excipients, chemicals or raw materials are described and verified with our capabilities. This will already involve extensive communication between our respective departments. We will move to the next phase when we have established a joint fit.
2. Development phase
A dedicated project team will initiate small-scale development to meet your needs. You will receive development-phase raw materials for your internal evaluation. This phase may include multiple steps to achieve the desired result. After your approval we will move to the upscaling phase.
3. Upscaling phase
The development-phase product is handed over to our process development teams for larger-scale production trials. Together with you, we will assess if this trial product still meets your requirements. Small adjustments based on your evaluation can still be incorporated in this phase.
4. Validation phase
In this phase, the manufacturing process is validated according to our internal procedures based on the defined requirements, GMP or non-GMP manufacturing standards. Upon successful completion of our validation and clearance of the product, it can move to commercialization.
5. Commercialization phase
The newly developed excipients, chemical or raw materials are embedded in our regular organization and will be supplied according to the agreed conditions.
All R&D activities will provide technical packages as
needed. Examples may include a full
dossier to support regulatory filings, Drug Master Files (DMFs) available upon
request for select GMP products, technical packages including design criteria
for building a full-scale plant, etc.
If you have a special request for a custom GMP, biopharma and non-GMP specialty chemical research and development, please CONTACT US.
