Quality, regulatory and sterility assurance
As a global drug delivery CDMO with a rich legacy of experience, we are committed to ensuring that quality and compliance are embedded into every stage of the sterile fill finish manufacturing journey.
Quality designed into every program
Quality begins long before routine manufacturing starts. Our teams work to define critical quality attributes and critical process parameters early in the transfer process, creating a foundation for effective monitoring, process understanding and control.
Sterility assurance
Integrated decontamination systems, glove testing, environmental monitoring and process verification activities support sterility assurance throughout manufacturing operations.
Regulatory expertise
Kindeva's regulatory specialists can support programs throughout development and commercialization with regulatory strategy, submission support, compliance activities and post-approval maintenance.
Quality systems that support collaboration
Quality depends on systems that provide clear visibility and keep teams aligned throughout the lifecycle.
Kindeva’s enterprise quality management systems support current Good Manufacturing Practice (cGMP) and Annex 1 requirements while enabling efficient collaboration between the two teams. Customer integration options, including Veeva connectivity, can support enhanced oversight throughout a program.
A layered approach to contamination control
Bridgeton’s contamination control strategy combines facility design, operational controls and isolator-based aseptic processing.
Key elements include:
- Modular facility design and HVAC systems
- Segregated personnel and material flows
- Process monitoring and verification
- Grade A isolators within Grade C cleanroom environments
In an article with Pharm Tech, Kindeva’s Chief Quality Officer, Melanie Cerullo, explores why contamination control should be viewed as a living system, and how manufacturers can create more resilient approaches to sterility assurance and compliance.
Discover how Melanie Cerullo views the roles knowledge sharing, quality culture and continuous improvement play in strengthening manufacturing performance and supporting long-term compliance.
Let's transform tomorrow together
Every injectable product has the potential to make a meaningful impact on patients’ lives. As your fill finish partner, we’re committed to helping you navigate manufacturing complexity and build a pathway to reliable commercial supply.