Pharmaceutical QbD/DoE
Quality by Design (QbD) has been proved the most effective method to achieve product and process efficiency and optimization. Scientists typically use statistical optimization performed by design of experiments (DoE) to optimize the commercial manufacturing process of APIs. This data-driven approach has developed process development knowledge by revealing relationships, including multi-factorial interactions, between the variable input and the resulting outputs or the final product. BOC Sciences is committed to providing high quality pharmaceutical QbD/DoE services that will achieve a consistent and high levels of quality suitable for process validation.
Figure 1. Comparison of the traditional and QbD approaches. (Carl-Fredrik, M. 2009)
Benefits of QbD/DoE
- Better understand the manufacturing process
- Reduce the occurrence of batch failures
- More effective control of the manufacturing process
- Greater time and cost efficiencies
Our Services
To make it easier and better for researchers, BOC Sciences provides pharmaceutical QbD/DoE 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.
- To ensure desired drug product quality, safety and efficacy, a Quality Target Product Profile (QTPP) is established prior to formulation development
- Determine the Critical Quality Attributes (CQA) of the drug product and perform a risk assessment to evaluate the impact of raw material attributes and process parameters on the CQA
- Create a design space that describes the relationship between the inputs (raw material attributes and process parameters) and the quality of the final product
Our workflow
1. Define QTPP
2.Define CQA
3.Outline Process Maps
4.Identify CPP (Critical Process Parameters) and CMA (Critical Material Attributes)
5.Risk Assessments
6.Design Space Studies
7.Update Risk Assessment
8.Control Strategy
Figure 2. Important features of the QbD. (Carl-Fredrik, M. 2009)
Critical Process Parameters Study
We focus our Quality Risk Assessment (QRA) studies on identifying validated Acceptable Ranges (PAR), Normal Operating Ranges (NOR), and CPP in the manufacturing process and complete these activities for each GMP phase prior to initiating PPQ batches
Impurity fate studies and Specification Justification Studies
BOC Sciences has established a general workflow for specification justification based on ICHQ11 guidelines
- Define and validate API CQAs
- Study the source and formation of actual and potential impurities in registered starting materials (RSMs) and isolated intermediates
- Collect impurity content and isolated intermediates from different batches of registered APIs
- Re-formulate or adjust the analytical methods of the RSMs and isolated intermediates to ensure that the actual impurities, potential impurities and impurities generated in subsequent reactions can be well separated
- Perform corresponding additional experiments on the actual isomers, potential isomers, analogs and other by-products in the synthesis process of the RSMs
- Collect the experimental data in the fate study of impurities in the RSMs and isolated intermediates, and compare them with the CQA of APIs to establish control strategies for RSMs and isolated intermediates
- Produce a quality standard reports
Figure 3. The design space and control space as defined in QbD. (Carl-Fredrik, M. 2009)
RSM studies
- Process and analytical knowledge demonstrating the RSMs and intermediate specifications will be appropriately documented in the Specification Justification report
- Physical properties of RSMs, process chain stability, molecular complexity, etc., can be used to help clients determine the appropriate RSMs
- Systematic investigation of impurities in RSMs on the basis define suitable specification and control strategy for the RSMs
Our main successful outcome
- Better scientific understanding of drug products and manufacturing processes
- Eliminate the unnecessary testing
- Optimize budgets and timelines
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 pharmaceutical QbD/DoE at competitive prices for global customers. Personalized and customized services of pharmaceutical QbD/DoE 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
- Carl-Fredrik, M. Quality by Design (QbD) for biotechnology-related pharmaceuticals. WILEY-VCH Verlag. 2009. 4(5): 600-609.
