Biologic Process, Production & Qualification (PPQ)

Consistently delivering Product Quality Attributes.

Process Performance Qualification (PPQ) is a critical step in the development of a biologic as it assesses a manufacturing process’s ability to consistently produce high-quality product. At Abzena, we understand that to ensure your commercial success, a robust Process Performance Qualification (PPQ) needs to be executed. One that must verify and validate your programs’ Product Quality Attributes (PQA).

PPQ demonstrates that a manufacturing process is reliable. It’s important for regulatory compliance and commercialization as it shows you can consistently produce products that meet predefined quality criteria. Our experienced scientists, engineers and advisors work with your team to develop tailored protocols and support you in delivering quality, reliable data for your regulatory filings.

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.

Through the experience of our leadership team there are many hundreds of commercially available products that are helping patients get the medicine they need.

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
Integrated Cell Line Development - Abzena

Let's move medicine forward.

We adapt our approach, shorten the lead times, and develop risk mitigation strategies to ensure your overall success.