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.
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.
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.
Comprehensive documentation, process descriptions, data trend analysis, reports supporting your entire product and process development and optimization journey, and regulatory filings.
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.
Our experience managing pre-qualification and optimization studies for isolation processes and separation technologies includes managing laboratory scale processes and large-scale processes up to 30,000 L scale. This includes the development and validation of the following: precipitation, centrifugation, microfiltration, depth filtration, cell disruption (microfluidization, homogenization), and periplasmic extraction.
