Talk to a Scientist

 

GLP, GMP Compliance

Marin Biologic Laboratories has 20 years of experience providing U.S. and international client needs in cell and molecular biology, biochemistry and immunology.  Marin Biologic is compliant with U.S. FDA cGMP/GLP standards as well as ICH for all levels of clinical development. Marin Biologic has developed, validated and performed hundreds of assays such as PK ELISAs, Anti-Drug Antibody (ADA) ELISAs, enzyme and cell-based potency assays, potency lot release assays, and neutralizing antibody bioassays that are compliant with GLP/GMP/ICH standards, as applicable.  Whether development of an assay or use of a commercially available kit, Marin Biologic employs cGMP/GLP/ICH standards that are phase appropriate for the client’s stage of clinical development. Marin Biologic has passed many inspections by the U.S Food and Drug Administration (FDA).

Marin Biologic also offers services to meet the regulatory needs and demands associated with Phase II and Phase III clinical trials. We offer a broad range of services and have a diverse range of clients from law firms seeking patent protection to those clients who are in various stages of their drug development process.  Our experts have years of experience working with clients and those entering Phase II and III clinical trials specifically to navigate you through the complex, regulatory challenges of the drug approval process. We tailor our services to meet your needs.

Regulatory Overview

Marin Biologic Laboratories is a contract research organization – CRO – performing GLP and GMP laboratory services. We have extensive experience in assay development and validation for drug substances and drug products for biologics.  Our services range from assay development for GLP & GMP studies, assay support for lot release and sample analysis to providing support for IND, BLA and NDA submissions.

Assay Development

If you need assay development or simply to transfer an assay to a CRO – to analyze samples for Heath Authority submissions, we will work with you to meet your long term needs, whether or not it requires GLP/ GMP compliance. Vendors and reagent lots will be selected to ensure that your reagents will perform consistently and provide continuity in your assay over time. For assay development, our scientists will perform the assay under protocols and identify those parameters such as the limit of detection (LOD), the limit of quantitation (LOQ) and the linear range that will be critical for assay validation which typically will be conducted under GLP or GMP compliance.

GLP / GMP Assay Validation

Once the parameters and range are set during the assay development or transfer, we will discuss with you the experiments necessary to show linearity, accuracy, precision, specificity, robustness, ruggedness and system suitability for assay validation. Often before we begin the assay validation, controls based on reference standards will be generated and aliquoted under GLP or GMP compliance which may be used over several years depending upon the stability of the reagents. We will discuss these issues with you during the assay development or transfer. Our scientist will perform the validation under GLP or GMP compliance and a report will be submitted to you for review and approval.

Potency, Assay, Drug Release Assay

If we have developed and validated your potency assay, whether it be a cell-based assay, enzyme assay, ELISA assay or some other assay, and you have accepted the final report, we can begin to analyze your samples under GLP or GMP compliance. If you need to submit documentation concerning potency for your drug release assay or stability study in a cell-based assay, we will discuss with you the parameters of your cell culture, your frozen stocks, etc. in order to maintain the cells with minimal variability from assay to assay over the years. If you have an enzyme based assay or ELISA assay we will discuss with you the storage conditions, controls, and other parameters that may impact your assay over the years. As part of our CRO services, our scientists will assist you in preparing your regulatory filings.

Examples of Our Expertise on 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