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CMC Consulting

"We assist biotech companies in the manufacturing sector to achieve results on time and within budget, when they face a lack of expertise or personnel" Daniel Lüscher, CEO QBDC CH

We accomplish this through a clear, three-step process


  • comprehensive method development

  • a robust control strategy for the manufacturing process 

  • successful scale-up with PPQ runs 

This means significant cost savings in production due to


  • highly efficient and robust manufacturing processes reducing your cost of goods 

  • reduced time to market for your product

 

Process 

Characterization

Our process characterization services ensure your product quality. Our focus is on analyzing critical process parameters and developing TPPs and CQAs for a clear understanding of the product. We define Critical Control Parameters (CPPs) and integrate them into a robust control strategy. 

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Project 

Management

We take full responsibility for your project from initial concept to successful commercial production. This includes detailed planning, precise management, and complete monitoring of all phases. Our holistic approach ensures timely, budget-friendly completion to the highest quality standards. 

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Process 

Development

Our experts assist in creating stable, high-performance cell lines and optimize methods to ensure product quality and reproducibility. We enhance the growth and productivity of your cell cultures, design efficient downstream processes, and ensure the stability and effectiveness of your products. 

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Qualification & Validation


Our service focus includes document creation for compliance, risk-based project management to enhance quality and safety, and GMP-upgrades to ensure facilities meet evolving regulations and adapt to product changes. We ensure accuracy, efficiency, and regulatory compliance.

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Bioprocessing & PAT


We help our clients streamline bioprocesses to reduce costs and improve quality, all tailored to their needs. Our tool, EDDI, provides complete cell data for precise characterization, eliminating guesswork and enabling informed decisions.

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