CMC Consulting

QBDC's Chemistry, Manufacturing, and Controls (CMC) consulting services are designed to guide biopharmaceutical companies through every stage of drug development, from initial concept to market entry. Their expertise ensures that products and processes meet the highest standards of quality, safety, and regulatory compliance.

Key aspects of QBDC's CMC consulting include:

• Regulatory Compliance: QBDC provides comprehensive support in navigating complex global regulatory landscapes (e.g., FDA, EMA, ICH guidelines). They help clients establish and maintain robust Quality Management Systems (QMS) and ensure all documentation and processes adhere to current Good Manufacturing Practices (GMP). This includes preparing and reviewing critical CMC documentation for various regulatory submissions (INDs, CTAs, BLAs, NDAs).

• Process Optimization & Development: QBDC works to streamline and enhance biomanufacturing processes for biologics, including Biosimilars, ATMPs, and NBEs. This involves:

  • Method Development: Designing and optimizing analytical methods for product and impurity characterization, cell line characterization, and comparability studies.

  • Process Characterization: Analyzing critical process parameters (CPPs) and defining critical quality attributes (CQAs) to ensure product quality.

  • Scale-up and Tech Transfer: Providing expertise in scaling up manufacturing processes and facilitating seamless technology transfer between sites or partners.

  • Downstream Processing: Designing efficient downstream processes to ensure product stability and effectiveness.

• Quality by Design (QbD) Implementation: QBDC integrates QbD principles into biopharmaceutical development, focusing on a scientific, risk-based approach to product and process understanding. This involves defining Target Product Profiles (TPPs), identifying CQAs, conducting process risk assessments, and developing robust control strategies.

• Lifecycle Management: They offer ongoing support for product lifecycle management, including managing post-approval changes, renewals, and compliance updates to ensure continuous adherence to evolving regulations and market demands.

• Cost Efficiency & Time to Market: By optimizing processes, reducing risks, and accelerating regulatory approvals, QBDC helps clients achieve significant cost savings in production and reduce time to market for their biopharmaceutical products.

• Project Management: QBDC takes a holistic approach to project management, from initial concept to commercial production, ensuring detailed planning, precise management, and comprehensive monitoring of all phases to deliver projects on time, within budget, and to the highest quality standards.

In essence, QBDC's CMC consulting provides the scientific, technical, and regulatory expertise necessary to develop high-quality, safe, and effective biopharmaceutical products efficiently and compliantly.