Central Laboratory TESTING Services

For over 10 years Marin Biologic has been performing GLP and GMP testing services for our client companies. From assay development, to validation, to preclinical and clinical-trial laboratory services, our customized protocols result in accurate and prompt testing. Data reporting is specific to your trial output and our staff interfaces with your statisticians to ensure customized data output if required.

Marin Biologic provides you with quality service and support. Our Central Laboratory testing experts can provide you with the attention to detail you need and expect. As clinical trials become more complex, expensive and data intensive, Marin Biologic has the resources to ensure your assay and other bioanalytical needs are met in a cost effective manner. Our staff is flexible with respect to assay, timelines, data presentation among other items to help you in your pre-clinical and clinical projects.

Preclinical Testing Services

Marin Biologic provides GLP and GMP pre-clinical testing services. We are able to perform a variety of tests in our newly constructed central laboratory. We help you to plan the tests required, then we keep in constant communication with you during the testing period. We analyze and compile the data according to your requirements so that your statistician can easily incorporate it into your final study documents.

Clinical Testing Services

Once your products have passed their pre-clinical testing, our central laboratory can analyze your clinical samples. Some typical assays we perform are immunogenicity, lot release bioactivity, biomarkers, pharmacokinetics, mechanism of action, pharmacodynamics, plus the assays listed in our web site. Confidentiality is of the utmost concern to us and our clients. If the assays were developed and validated at Marin Biologic, a simple process allows our operators to perform the assays according to the SOPs generated during the development, validation and preclinical testing services. If the validated assays are to be transferred to Marin Biologic, a technical qualification will be performed and the data submitted to you prior to analyzing your clinical samples. Our scientists will discuss the transfer and qualification so that any specific or unusual features in the assay are captured during this process.

Some of our clients have requested that the Marin Biologic staff present the assay methods and/or data to their colleagues, investors and to FDA reviewers. We discuss the presentation prior to the event, and support their presentation as required. This has yielded good results and our staff is glad to perform this service for you.

Our Central Laboratory Process

Prior to receiving any samples, our staff will confer with you about receipt date, sample ID, storage conditions, and other items that need to be tracked. We will interface with your statistician about data presentation into your format. The time schedule will be discussed with you so that your data will be collected to meet your needs. The schedule at Marin Biologic will be developed and staff will be ready to analyze your samples. Our Central Laboratory receives client clinical samples from around the world. The samples are logged into our system and stored at their appropriate temperature, -70°C, -20°C, 2-8°C or ambient temperature in your client specific container. We will notify you of the receipt of your samples, to keep you informed. The assays will be performed and data will undergo a rigorous quality control inspection.

If appropriate, the assay will be conducted incompliance with FDA regulations and undergo the quality assurance inspection. A report will be generated and delivered to you for review. Any edits you wish will be communicated to Marin Biologic and after discussion and revision, a final report will be issued. We follow up to ensure you received the report and discuss the disposition of any remaining samples.