With opportunities for yield improvements and drug product homogeneity at the forefront of our product and process development efforts, BioTechLogic’s team of CMC experts works with clients to develop, optimize, and validate robust, scalable, cost-effective, and compliant manufacturing processes.
Creating a foundation for your product and process development program, we utilize a QbD framework to thoroughly understand the quality characteristics essential for safely delivering your drug product’s intended therapeutic effect.
Leveraging design of experiments (DOE), we perform a systematic evaluation of your manufacturing process, establishing a thorough understanding of how critical process parameters (CPPs) influence your final product’s critical quality attributes (CQAs). Additionally, our process parameter risk assessments identify the process parameters posing the highest risk to your production process to support risk mitigation planning.
Thorough analysis, often including an extractables and leachables risk assessment, of the impact of raw materials, excipients, consumables, and intermediates on process performance and product quality.
Comprehensive documentation, process descriptions, data trend analysis, reports supporting your entire product and process development and optimization journey, and regulatory filings.
We have led and provided the overall strategy for 32 process validation programs.
20 approved by the FDA and/or EMA
2 submitted and in review by FDA and/or EMA
10 ongoing global process validation programs
Additionally, we have served as major contributors to 31 approved submissions resulting in commercial products.
