Antiviral API Services
With the deeper understanding and investigation of viruses, antiviral drugs have played a main role in the prevention and treatment. Antiviral APIs are small-scale varieties in the overall API category. In general, antiviral drugs with the largest scale of use are mainly entecavir and tenofovir for hepatitis virus treatment, and oseltamivir for influenza. In the field of traditional anti-HIV and hepatitis virus products, there are several products, of which the representative varieties are: acyclovir, nevirapine, tenofovir, lamivudine, zidovudine, efavirenz, etc. In addition, there are some new potential antiviral APIs such as direnavir and dolutegravir.
BOC Sciences provides high-quality active pharmaceutical ingredient services for small molecule antiviral drugs to partners worldwide. Our API team helps you develop safe, scalable and efficient API processes. We have extensive antiviral API development capabilities ranging from route scouting and design, through to process optimization and full validation support, including quality by design (QbD).
Our Capabilities
In the early stages of antiviral drug development, antiviral APIs must undergo a rigorous testing and research process to ensure that the potential therapies are safe and effective. To support early stage programs, BOC Sciences offers a wide range of antiviral API development technologies and solutions. Our comprehensive antiviral API services include:
- Design and selection of new, scalable synthetic routes
- Process development and safety assessments
- cGMP starting material evaluation
- Sourcing and development of raw materials
- Polymorph screening and salt selection
- Analytical method screening and preliminary stability analysis
- Preformulation and preclinical supply
- Selection of viable drug candidates
Figure 1. Anti-Candida active pharmaceutical ingredients; a: diflucan, b: voriconazole, c: itraconazole, and d: isacuvonazole. (Billes, F.; et al. 2016)
Our process department adopts QbD principles for API process development of antiviral drugs, and strives to select the best route for our customers to optimize the API production process and improve product quality and production efficiency. BOC Sciences' API process optimization services include: establishment of quality standards for APIs, optimization and determination of important process parameters, determination of post-treatment methods, optimization of purification methods, and process risk assessment and control, process safety evaluation, impurity profile study.
Determination of the optimal solid form of APIs is a critical step in its entry into the market, and the solid form of a drug product directly affects its solubility, bioavailability and therapeutic efficacy. Choosing the right solid form early can make the development and manufacturing process more efficient and cost-effective, and reduce the risk of unexpected challenges. BOC Sciences provides antiviral API solid state chemical services, tools and technologies to support different development program, delivering APIs with the properties required to improve material efficiency and therapeutic success. Our comprehensive solid-state chemistry services including solid form screening and crystallization development allow us to help you get your ideal form of API through production and to the market. Combining solid state expertise with BOC Sciences' state-of-the-art equipment and analytical laboratories, we are able to support a broad range of API solid form investigations and robust crystallization development programs for a variety of antiviral drugs.
BOC Sciences has an IND-based cGMP API manufacturing line that includes preclinical laboratory scale testing and process development through to commercial production. Our experts meet the diverse needs of our customers throughout our integrated supply chain, including R&D, sourcing and manufacturing. From the milligram- and gram-level to kilogram level, our synthesis & manufacturing processes allow flexibility to adapt to our customers' innovative process development.
Accelerate your discovery-to-market timeline by partnering with BOC Sciences to produce your active pharmaceutical ingredient. We continually update our innovate technology to ensure the control of key product attributes, which leads to successful pharmaceutical scale-up. BOC Sciences is committed to advancing your antiviral program from initial feasibility study, process development to scale-up through process validation.
- Evaluate analytical data in accelerating cGMP-scale discovery to market
- Synthesis labs support scalable API production to larger scales
- Consiste lot-to-lot reproducibility at different stages of API scale-up production process
- Support API early scale-up and high potency scale-up
Why Partner with BOC Sciences?
- We apply over 50 years of proven expertise in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing services
- 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
Reference
- Billes, F.; et al. Vibrational spectroscopic study of sodium-1,2,4-triazole, an important intermediate compound in the synthesis of several active substances. Spectrochimica acta, Part A: Molecular and biomolecular spectroscopy. 2016. 53: 349-362.
※ Please kindly note that our services are for research use only.
