Biologic Process, Production & Qualification (PPQ)

Consistently delivering Product Quality Attributes.

To ensure your commercial success, a robust Process Performance Qualification (PPQ) needs to be executed to verify and validate your programs’ Product Quality Attributes (PQA).

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Our experienced scientists, engineers and advisors work with your team to develop tailored protocols and support you in delivering data for your regulatory filings.

Streamlining your project, our systematic, science-led approach is built on a deep understanding of your product, process, and analytics, as well as the regulations, guidelines, and expectations of global regulators.

Many hundreds of commercially available products are helping patients thanks to the experience of our leadership team.

Our Approach

By creating a PPQ strategy we mitigate risk and define your validation campaign, ensuring the success criteria of your program including the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).

We understand your product’s process requirements, its development pathway, and its market and patient potential allowing us to develop the right profile for commercial launch.

Our approach to your PPQ is to work directly with your team to ensure we include:

  • Specific manufacturing conditions
  • Equipment design and qualification
  • Sampling conditions
  • Analytical and testing methods
  • Process controls
  • Regulatory authority feedback
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