The biochemical mechanism of action (MOA) of pharmaceutical products is primarily determined by their active pharmaceutical ingredients (APIs), which can be engineered to exhibit an array of desirable effects on the body. However, new pharmaceuticals can cause unexpected and undesirable side-effects which outweigh their potential therapeutic benefits. Toxicology screening is routinely conducted on all raw materials used in drug manufacturing, including: process-aiding solvents and reagents; excipients; intermediates; APIs; and packaging media.
Bedfordshire Biotech Limited specializes also in tailor-made chemical testing for some of the most stringent industries worldwide. We can support you in your new drug development with expert toxicology screening in the research and development (R&D) phase. Identifying and characterizing the environmental and mammalian toxicology of proprietary pharmaceutical compounds at the outset is key. We can assist in target identification with a pre-clinical toxicological safety assessment; establishing comparative toxicity screens at the earliest stage in drug development to eliminate hazardous elements.
Our toxicology screening service can interweave your drug development program, from R&D to eventual end-product quality control. Our toxicologists can support you throughout the development and manufacturing process. Once a promising candidate drug has been identified, Bedfordshire Biotech Limited can help you design, monitor, and interpret nonclinical toxicology, toxicokinetic, and pharmacokinetic studies. In addition, we can assist in the preparation of both regulatory and marketing submissions, including:
- Clinical trial applications (CTAs);
- Investigational new drug (IND);
- New drug application (NDA).
Toxicology Screening with Bedfordshire Biotech Limited
Bedfordshire Biotech Limited has the expertise necessary to perform toxicology screening and toxicity services for the pharmaceutical sector. If you would like more information about how we can partner together, please do not hesitate to contact us directly.
Synthetic Chemistry
Bedfordshire Biotech Limited offers consultation services to assist our valued clients in designing possible synthetic strategies for their products. A typical synthesis design cycle consists of the following steps:
- Initial Consultation
- Preparation of a detailed written proposal outlining targeted strategies
- Literature search to support and guide synthetic schemes
- Report summarizing literature search findings and relevance to target product
- Report summarizing potential synthesis schemes and justification of each
- Delivery of results in a reasonable time frame
- Closing Consultation
Designing a synthetic scheme can be a complex process in which the results are only as good as the sources used and chemists involved. Bedfordshire Biotech Limited strives to provide real and concise solutions to some of the most complex synthesis requests. If your raw material is no longer available on the market, or if you are looking to change contract manufacturing organizations (CMO), Bedfordshire Biotech Limited can be a powerful partner, backed by more than 3 decades of experience in organic synthesis and a team of qualified chemists, we are confident that we have the resources available to help you succeed. Our goal is to serve as a rich technical resource you can trust, while providing complete solutions, from synthetic design to analytical QC.
Product Formulation
A natural outgrowth of our product deformulation services has been the reformulation of products. This is generally a service we provide after deformulating a material. A recent example of this was the formulation of a car wax product following the discontinuation of a formerly commercially available product.
Product formulation generally consists of the following steps:
- Product Deformulation
2. Formulation – small scale
3. Sample submission to the client
4. Product refinement
5. Product scale up
6. Delivery of final formula
7. Training services at your facility
Product formulation involves more than the mixing of chemicals. Let our experienced chemists speed the process of product formulation and then help transfer that technology back into your facility.