Antiviral API Synthesis & Manufacturing
The synthesis and manufacturing of small molecule antiviral APIs is a complex challenge that requires chemical expertise as well as specialist facilities, regulatory experience and supply chain management.
BOC Sciences has developed a standard workflow:
- Route selection
- Process optimization
- Quality studies
- Process validation
- Technology transfer
Figure 1. Continuous Pharmaceutical Tablet API Manufacturing Processes. (Singh, R.; et al. 2015)
- Synthesis Route Design
The selection of route will not only affect the possibility of industrial production, but also the production cost, product quality and even the environment. In early clinical development, optimal synthesis routes are critical to the speed of delivery of drug products. At BOC Sciences, we can perform route scouting, route comparison, and development and scale-up of new synthetic routes for your drug substance. Our experts will screen multiple synthetic routes to determine the most appropriate synthetic pathway for your antiviral drug molecule. Through our evaluation of the technical feasibility of the selected route, availability of equipment, availability of raw materials and reagents, reaction steps, patent protection and environmental impact, we help our clients select and develop reliable, low-cost, safe and environmentally friendly synthetic routes for large-scale production of antiviral APIs.
Our Capabilities
- Salt form selection, research and process development of crystalline forms
- Parameters optimization for the synthetic route
- Statistical and experimental design based on quality by design (QbD) principles and multivariate data analysis
- Production Process Development & Optimization
Combining our comprehensive, cross-industry experience with our extensive synthetic chemistry and industrial expertise, we are able to develop scalable, safe, economical and robust processes to produce a variety of antiviral AIPs.
Our Capabilities
- Process safety - toxicity, thermal and reactive hazard screening
- Environmental impact - assessment of environmental and sustainability aspects of API production, including toxicity, waste generation and depletion of natural resources
- Legal advice - patent infringement and use of controlled substances
- Economic evaluation - comprehensive assessment of selling prices, marketing costs, and technology licensing
- Quality control - evaluation of the quantity and efficiency of the purification process, any non-selectivity and side reactions, and the chemical stability and physical properties of intermediates and reagents
- Production yield - improve yield by evaluating limiting factors
- API Synthesis & Manufacturing
As a leading manufacturer of small molecule APIs for over 50 years, BOC Sciences combines the scientific and engineering expertise with close collaboration to help our customers solve the complex challenges of antiviral API manufacturing. Our flexible and customized approach allows us to support the most specialized and complex project requirements.
Our Capabilities
- We offer integrated small molecule solutions from GLP toxicology, through the clinical stage, to commercial supply, in scales from grams and KGs to tons
- We offer API manufacturing services including lab-scale tested manufacturing, safety-assessed bulk production, pilot-scale tested manufacturing, and GMP-based manufacturing
Figure 2. Flow synthesis of imatinib. (Baumann, M.; Baxendale, I. R. 2016)
Synthetic Chemistry
- Parallel chemistry
- Chiral synthesis
- Flow chemistry
- Continuous processing (Flow chemistry)
- Crystallization & micronization development
Our Capabilities
- At BOC Sciences, synthetic routes for antiviral APIs are designed and explored by experienced chemists, and we can also evaluate the suitability of current routes or reaction steps for scale-up in terms of material cost, safety, timing, operability, etc
- Combined with a variety of analytical tools such as LC-MS, GC-MS and NMR, multiple synthetic routes are advanced in parallel for route exploration to quickly screen the optimal synthetic routes for subsequent process development
- Over 20 years of experience in the use and production of hazardous chemicals supports the development of synthetic routes
- In addition to well-equipped facilities, we have a breadth of experience with a variety of chemical transformations including reductive amination, organometallics (RMgX, BuLi, LDA), halogenations (POCl3, SOCl2, SO2Cl2), reductions (LiALH4, NaBH4, DIBAL), suzuki couplings, Pauson-Khand cyclization, peptide chemistry and hydrogenation (catalytic, hydrogen transfer)
Figure 3. Container sized portable mini factory. (Baumann, M.; Baxendale, I. R. 2016)
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing Synthesis & Manufacturing
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
References
- Singh, R.; et al. Advanced Control of continuous pharmaceutical tablet manufacturing processes. Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture. 2015. 191-224.
- Baumann, M.; Baxendale, I. R. The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry. Blstn Journal of Organic Chemistry. 2016. 47(12): 1194.
※ Please kindly note that our services are for research use only.
