Pre-formulation Design
Before initiating pharmaceutical formulation activities, pharmacologists conduct pre-formulation studies to characterize and determine the physicochemical properties of the drugs. Knowledge of the relevant physicochemical and biopharmaceutical properties determines the appropriate formulation and delivery methods for preclinical and Phase I studies. For biological drugs, pre-formulation studies include a screening process to find the most optimal conditions to support downstream processing and to ensure the best conditions are selected in terms of CMC properties, which will prove beneficial for further drug product development processes. In addition, during pre-formulation studies, relevant analytical methods are optimized for the subsequent application. BOC Sciences' experienced scientists enable to add tremendous value to our clients' preclinical programs by creating synergies between solid-state chemistry and formulation development, while reducing time.
Features of our services
- Seamless integration with downstream processing
- Design of Experiment (DoE) methodology
- Comprehensive drug characterization
Figure 1. Drug development process. (Khorasani, A. A.; Morales, C. S. et al. 2014)
Our Services
To make it easier and better for researchers, BOC Sciences provides pre-formulation design service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
- Our team fully understands that the focus of early stage work is to learn as much as possible about a drug compound. Our experts have extensive experience with numerous chemical classes and a wide selection of dosage forms, allowing us to develop analytical methods to assess chemical properties, purity, compatibility and stability
- Our in-depth knowledge of compound from pre-formulation guides us in designing manufacturing processes that control product quality attributes and ensuring that products meet their Quality Target Product Profile (QTTP)
- We offer a full range of analytical techniques and tools, from XRPD to proton and carbon NMR, and from mass spectrometry to hygroscopicity testing
- Our extensive experience with different classes of drug substances and dosage forms allows us to help our customers fully investigate the chemical compatibility, degradation pathways, and stability of different dosage forms
Preformulation capabilities
- Early physical form screening
- Screening of buffers and pH levels
- Development of (frozen) liquid protein formulations (low vs. high protein concentrations)
- Crystallization optimization
- Physical characterization - XRPD, SEM, PSD
- Purity/impurity testing
- Stability testing and forced degradation studies
- Excipient compatibility testing
- Structure characterization - LC-MS, full range of proton and carbon NMR techniques, single crystal X-ray analysis, chiral purity
- Pre-clinical formulation & drug delivery
- Drug substance characterization including melting and aggregation point determination, purity, protein charge (pI), peptide maps, particle size and activity (ELISA based)
Figure 2. Suggested standardized characterization techniques. (Khorasani, A. A.; Morales, C. S. et al. 2014)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of pre-formulation design at competitive prices for global customers. Personalized and customized services of pre-formulation design can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Khorasani, A. A.; Morales, C. S. et al. Closing the gap: accelerating the translational process in nanomedicine by proposing standardized characterization techniques. Int J Nanomedicine. 2014. 2014: 5729-5751.
