Our Mission
For therapeutic proteins and biologics, the US Food and Drug Administration (FDA) mandates "that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably". To achieve this requirement, the FDA recommended (in its 2011 Process Validation Guidance) the use of a process validation lifecycle management approach consisting of 3 separate stages of process validation. These stages are presented in the figure below.
Prior to the inception of Process Validation Lifecycle Management Consulting Ltd (PVLMC), we designed lifecycle management quality systems for several Fortune 500 biologics corporations which led to the commercial approval of at least ten therapeutic proteins. PVLMC was created to assist new and established biologics companies to create quality systems which can meet stringent FDA and ICH regulations while doing so without costly regulatory delays.
Stages of the Process Validation Lifecycle
Stage 1
Process Design Stage:
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Determine the potential CQAs (pCQAs) and the quality target product profile (QTPP)
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Understand variability in the process.
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Design a process which can meet the bulk drug substance (BDS) CQA limits/specifications.
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Generate the process control strategy for use in your commercial manufacturing process (Stages ll and lll).
Stage 2
Process Qualification Stage:
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Facility qualification studies are completed prior to PPQ except for activities that are allowed to go through concurrent validation (i.e. cleaning validation).
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Process performance qualification (PPQ) studies are performed to verify that the commercial process (as outlined in your process control strategy) can consistently achieve your final product quality (i.e. fCQAs).
Stage 3
Continued Process Verification Stage:
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The process undergoes a state of process monitoring.
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CPV plans, CPV reports, PPQ re-qualifications, change controls, deviations and out-of-specification results all inform the annual product reviews.
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The process control strategy should be updated as additional feed-back (CPV results, deviations, etc.) is assessed.
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Additional Stage l activities may be initiated if changes to the process are required.
PVLMC Approvals
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Impact on Our Clientele
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After completion of multiple major scope of works (SOW) for two of our clients, they were each subsequently acquired by major biotech companies for greater than 1 billion dollars.
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One of our clients received regulatory approval of two biologicals/therapeutic proteins after we helped re-design their process validation quality system and provided global process validation training.
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Another of our clients gained regulatory approval for a biological/therapeutic protein after we helped with their CQA determination and updating part of their process validation quality system.
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Led process validation initiatives to take a biologic from being phase 3-ready to PPQ-ready in 3 months in support of the FDA Coronavirus Treatment Acceleration Program (CTAP)
Why Choose Us
Streamlined Approval
We focus on best practices that eliminate filing delays by balancing compliance and practicality. Our proven strategies have resulted in multiple FDA approvals with no 483s
Tailored Support
We've successfully served both small and large biotech companies, helping build quality systems for Fortune 500 biopharmaceutical companies and gaining approval for best-selling biologics. Our focus is 100% on your needs, ensuring regulatory compliance while minimizing unnecessary costs and time.
Biologics Industry Development
We have an exceptional rapport with regulatory agencies, and consequently, our strategies have been proven to be tried and true. We've also been involved in refining new strategies with the agencies to help lead the way for the biologics industry.
Proven Track Record
With over 250 biologics approved to date, we've secured approval for nearly 10% of those, including monoclonal antibodies, vaccines, recombinant proteins, interleukins, sublingual immunotherapies, and biosimilars. We've also worked on numerous early-stage products.
Comprehensive Expertise
Our extensive experience spans all stages of biologics development, from process inception to regulatory approval and ongoing process monitoring. We're well-versed in all three FDA process validation stages, ensuring that your product complies with the highest standards.
Diverse Capabilities
​We have extensive experience with various cell lines and mechanisms of action (MOA), making us adaptable to diverse biologics projects.
Professional Training & Consulting Services
Empower your journey with comprehensive expertise, tailored support, and knowledge from PVLMC (Process Validation Lifecycle Management Consulting Ltd). We offer a unique blend of training and consulting services, specializing in biologics development, qualification and regulatory approval. Whether you're initiating a unique project or need support across any of the three process validation stages, we're here to assist. What sets us apart is the seamless integration between our training modules and consulting services, which ensures that you have the expertise, knowledge, and guidance needed to succeed in a competitive market.