Niracle, LLC

Our Services

The founders of NiRACLE believe Process Analytical Technology (PAT) and Quality by Design (QbD) represent the future of the pharmaceutical industry. As a knowledge-based company, NiRACLE will serve clients in these areas. As implied by its name and logo, NiRACLE is specialized in Near Infrared (NIR) technologies including the conventional NIR and NIR chemical imaging. NiRACLE is also specialized in multivariate data analysis and modeling. The combination of both forms a powerful tool that is badly needed in pharmaceutical research and development.

Although NIR and multivariate data analysis are becoming popular in the pharmaceutical industry, along with PAT and QbD, the sciences behind them are not well publicized and understood. This is due to them not having been part of the core curriculum of chemistry professionals for a long time.

METHOD DEVELOPMENT

NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and are intended for supporting early stage formulation development and late stage commercial production scale up. GMP NIR methods are for tablet content uniformity testing and can be used for supporting NDA/ANDA filings. NiRACLE also assists clients in developing real-time process monitoring methods for various unit operations including blending, film coating and granulation. The services also include experimental design, method validation and method transfer.

PROCESS VALIDATION

NiRACLE is specialized in multivariate data analysis, which plays a critical role in today’s process validation. NiRACLE works with clients in selecting suitable process monitoring methods and designing a comprehensive sampling plan. NiRACLE’s technology allows for the fast analysis of thousands of process related samples for mapping the manufacturing processes. Our services are extremely cost-effective and the results will give clients a much better understanding of their manufacturing processes and products.
PHARMACEUTICAL PRODUCT/PROCESS TROUBLESHOOTING
Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems. Examples include content uniformity related failures, dissolution problems, polymorph conversions during manufacturing and stability studies, drug release related issues for prolonged release formulations, and problems related to fluid-bed wet granulation processes.