Antiviral API Scale-up Production
In the early stages of drug development, the synthetic routes of a drug substance is likely not to be the final process. With improved synthetic routes or better crystallization processes, the physicochemical properties of APIs may change. To ensure that the most promising drug candidates hit the market, many pharmaceutical companies are faced with the challenge of accelerating the development of antiviral drugs and making their processes more cost effective. API scale-up production refers to addressing the process development, scalability, and stability challenges through the systematic and scientific solutions to reduce the risk during drug development and thus avoid costly late-stage failures.
Collaborate with BOC Sciences' team of experts to produce your antiviral drug APIs and accelerate your projects from discovery to market for your drug molecule. We are committed to advancing your antiviral API project from initial process development to scale-up to process validation.
Figure 1. Scale-up methodology for pharmaceutical granulation. (Jang, E. H.; et al. 2020)
Our Capabilities
- Gain a comprehensive understanding of the API development process of small-molecule antiviral drugs
- Understand the life cycle of small-molecule antiviral drugs from development to commercial launch
- Explore the API requirements at different stages of antiviral drug development
- Evaluate analytical data during accelerated cGMP scale up discovery to market
- Provide chemical scale-up and process development expertise
- Quality-driven approach to quickly complete the feasibility studies
- Maintain the key product attributes during the API scale-up process
Advantages of Our Scale-up Services
BOC Sciences' scientists understand that rapid entry into the clinic - and then into the marketplace - is the key to success, and we address formulation, process development, scalability, and stability challenges with systematic and scientific solutions to reduce risk in the development of antiviral drugs in the API scale-up manufacturing.
- Continuous flow process
- We validate our scale-up process and set specifications for process parameters, such as flow rate, mixing rate, hold time, etc., prior to manufacturing clinical trial materials of antiviral API
- Quality by Design (QbD) principles and develop a specific Design of Experiments (DoE) are introduced to improve the success of antiviral drug API scale-up production
- CMC documentation
- We provide all necessary CMC documentation for regulatory filing
- Quality Control
- We provide quality assurance and validation through pharmaceutical scale-up by employing our in-house quality control system
Figure 2. Application of physics-based modeling method for pharmaceutical scale-up process. (Jang, E. H.; et al. 2020)
- Early Scale-up
BOC Sciences' cGMP kilo labs support scale-up production of antiviral APIs, advancing your antiviral drug candidate for early scale-up, preclinical studies and Phase I clinical studies. We support production of initial batches of cGMP from 100 g to 5 kg.
Our production equipment includes:
- Different sizes of glassware (12 liter, 22 liter, 50 liter and 63 liter)
- Enclosed suites, including process hoods, rotary evaporators
- Class 100,000 single pass air
- High Potent Compound Scale-up
Our production equipment includes:
- Synthesis labs with 22 L glass vessels
- Scalable to larger sizes with jacketed reactors up to 50L
- Isolators with built-in tray dryers
- Laminar flow hoods
- Local exhaust ventilation
Figure 3. Scale-up studies using the engineering-based modeling method. (Jang, E. H.; et al. 2020)
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 APIs analysis and 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
Reference
- Jang, E. H.; et al. Model-Based Scale-Up Methodologies for Pharmaceutical Granulation. Pharmaceutics. 2020. 12(5): 453.
※ Please kindly note that our services are for research use only.
