Talk to a Scientist

 

GLP/GMP Assay Development and Validation

What are GLP and GMP?

Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) are terms that define principals intended to ensure safety and quality. Generally, when a drug passes through the IND step with the FDA, most activity will be conducted under GLP conditions from that point forward and subsequently into Phase III will need GMP conditions.

Assay – Custom Development

When you need an assay to prove your science and there is no commercial kit available to help, you need a custom assay. Our extensive expertise can rapidly develop your assay to prepare it for eventual validation. Typically an assay can be developed from scratch in 5 or less experiments while minimizing any matrix effects.

Assay – Kits

We are firm believers in kits. The analytical portion of the assay itself is only a single component of what it takes to perform a successful experiment. It is all the other skills, experience and GLP/GMP conditions that we do day in and day out that will save you calendar time getting to the results you actually want yesterday.

Assay Qualification

Many companies planning an IND submission or in Phase I/II may only require a well qualified assay, rather than a fully validated assay. You may or may not need GLP/GMP stringency. Our scientific team will collaborate with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy.

Assay Validation

To validate an assay is to measure precision, linearity, accuracy, robustness, repeatability and system suitability. To achieve these results we conduct a pre-validation phase with the assay. This phase is a series of 2-4 experiments that specifically look at these optimizations. Once we have an optimized assay, we perform the assay 2 more times for a total of three identical repeats. At that point, your assay is in compliance with FDA requirements under GLP/GMP requirements depending on your needs.

Sample Analysis, Clinical Testing, Toxicology Studies

Whether patient samples or drug product samples we will map out a  timeline and follow through in sample receipts, meeting your regulatory needs at all points. We perform your assay as developed, qualified or validated, and promptly communicate the results and/or Certificate of Testing for any or all of your preclinical or clinical phases.                             Speak to a Scientist

Why does GLP/GMP cost more?

The application of GLP and GMP principles into practices creates an environment in which uniformity, consistency, reliability, reproducibility, quality and integrity of pharmaceuticals are consistent and auditable. The value of these practices is to have auditable evidence that every measure has been taken through the supply chain and in the procedures to ensure the authentic and accurate treatment of the material, equipment and documentation that will ensure public safety as a result.

Both GLP and GMP practices require significant added investments in equipment, training and procedures to achieve the standard we set for both. Research and exploration level efforts would not need to use these procedures, however, moving through the FDA IND through Clinical Trials may depending on your specific circumstances with the FDA.

Our Practice

We conduct a broad spectrum of work inside the GLP/GMP conditions. Our team is trained to think in terms of GLP/GMP practices at all points of the process. That level of awareness brings a consistent and deliberate approach to all the work we do.

Examples of Our Expertise with GLP/GMP Assay Development

  • Cell Based Assays
  • Cytokine, Growth Factor, Antagonist
  • ELISA Assay
  • Antibody, other Immunoassays
  • Enzyme Assay
  • Compatibility Assays
  • Protein Chemistry
  • Chromatography
  • Cell Biology
  • Biochemistry
  • Immunology
  • Molecular Biology

Examples of Our Expertise on GLP/GMP Assay Validation & GLP/GMP Support

  • GLP, GMP
  • USP, FDA, ICH Guidelines
  • SOPs
  • Protocols
  • Tech Transfer
  • Assay Development
  • Assay Validation
  • Sample Analysis
  • Potency Assay
  • Drug Release Assay
  • Stability Assay
  • Regulatory Support, IND, NDA
  • Study Reports for Submission

Clinical Trial Services

Our Phase III capabilities and resources provided to our clients will be unique to the needs of our clients.  We understand that no two clients needs are the same, and we strive to keep an open channel of communication and feedback system in place so that you are kept aware of the ongoing progress of your project.

We recognize that clinical trial development of new medicinal products are often complex and challenging, and that quality and regulatory compliance are integral to the overall outcome of your clinical study. Marin Biologic’s regulatory team will offer the confidence our clients’ need during different phases of their clinical trials, from IND, NDA/BLA submissions and all the way to commercialization.

GLP, GMP Compliance