CONTRACT RESEARCH ORGANIZATION - CRO
GLP GMP COMPLIANT
 How Marin Biologic Laboratories Becomes Your CRO
You’ll be tapping into years of experience leading to a successful project outcome from the very beginning!
FDA Application
Is yours a research-level study or is the goal to be included in an FDA submission? Typically these projects require the development of an assay to show potency (e.g. drug release assay) or to demonstrate efficacy in an IND submission. Often a client company will need or want to demonstrate the “lack of” immunogenicity of their drug. Our scientists will lead you through the type of assay you’ll need. During these communications our scientists will discuss the pros and cons of the various approaches so that you will be able to make an informed decision. In essence we can act as your scientific consultants, though we do recommend that you obtain a regulatory consultant who will be apprised of and can coordinate your entire FDA submission.
Proposal
We partner with you to design a fair-value proposal that meets your scientific and drug development needs.
- Jointly tease out sufficient contract detail for a successful project.
- Estimate the cost and time-line of your project.
- We can also make suggestions on how to reduce costs, such as bundling your assays by testing multiple samples at one time, thus requiring fewer assays.
- We may discuss how to enhance the precision and accuracy of the assay.
- The format and level of detail needed in your report will be set to meet your project needs.
- Marin Biologic will have staff assigned and a timeline set when you are ready to start the project.
- Your signed contract and retainer to cover upfront expenses (supplies and some labor) will initiate your project!
Project Management
KICKOFF: After the project is initiated, the typical course of events will start with samples being shipped to Marin Biologic. From there...
- You inform us when to expect the sample.
- For GLP & GMP projects, a chain of custody form will be submitted with Certificates of Analysis and a list of all the samples.
- The samples will be logged in to provide traceability and stored at the required temperature.
- A project manager/scientist will be assigned to your project and will frequently communicate the progress of the project.
COMMUNICATION: As decisions are made during the course of a project you will be kept informed of progress. You dial in how informed you want to be on each project. For example, on very complicated experiments we can transmit the data after every experiment. Or, if you want to be less involved, we will make sound scientific judgments as the project progresses and just keep you informed. If we are waiting to expand cells or waiting for reagents we will of course provide you with an update.
FINAL REPORT: At the conclusion of the project a final report will be submitted for your review, as per the original proposal. Should additional reporting be required, we can always accommodate such requests. Your report will be submitted electronically, except for GLP/GMP projects where they are submitted in writing. Our scientists at MBL are here to facilitate your comprehension of the data and report. It is difficult to know all the innuendos when you are not designing plate maps and dilution schemes yourself. If your level of involvement is at this level we will be happy to accommodate this degree of interaction. On the other hand, if you wish to be apprised of the results only, we will gladly send data and summarize the results for you too. At the conclusion of the project if you need further assistance, we will be happy to provide it. In those cases where we are called up to represent our client in data discussions with the FDA, know that we observe strict confidentiality and formality in those situations.
COMPLEX PROJECTS: Because of our high Ph.D. to research assistant ratio, 1:2, Marin Biologic is able to successfully complete complex projects. We have Ph.D. expertise that spans the area of cell biology, biochemistry, molecular biology, and immunology. This enables our experienced scientist to work with complex biomolecules, to be cognizant of solubility and stability including freeze-thaw and other methods to ensure no change in reactivity during transit from clinical cites to a central testing lab such as Marin Biologic. The interaction between our biochemists and your clinical site contact ensures a seamless handling of your drug. The interaction between our biochemists and our cell and molecular biologists ensures that your drug will be handled appropriately during assay development. Assay development performed at Marin Biologic includes a wide variety of assays, whether cell-based receptor binding or other modalities of activity (e.g. cell signaling), interaction with biomolecules, effective concentration and potency determination.
We routinely perform inhibition of enhancement generate cGMP cell banks for future use. Some assays have included receptor binding in membranes of cells, equilibrium dialysis, phosphorylation or receptor, adsoption onto suhstratum or serum proteins, or activation of immune cells. We have phlebotomists on call to help us obtain white blood cells. We have cloned difficult DNA sequences that are large and optimized expression and restabilized (refolded) those found in inclusion bodies. We have purified protein to homogeneity. Since our scientists are experienced PhD’s, working with experienced research associates, we can efficiently and successfully take your project to completion. Communication is a key ingredient between our scientist and your company. As many companies need to demonstrate a lack of immunological activity in their drug, Marin Biologic routinely performs MLR & CMC assays for our client companies.
Assay Development and Validation
In our assay projects we typically analyze a positive and negative controls and some assays require a dose-response curve or are a cut point assay. We develop assays with the knowledge that it will be validated. Only reputable reagent vendors are used, and if needed a backup vendor for critical reagents are identified.
As the assay development nears completion, Quality Control (QC) Standards will be discussed with you and enough produced to last through validation and sample analysis. During this stage it will be decided whether single use aliquots will be manufactured and stability of critical reagents need to be studied. Critical reagents such as serum for cell based assays or animal / human serum for the QC matrix will be determined with you and sufficient amount purchased to last the study lifetime.
Our scientists act as your consults, making recommendations and allowing you the final decision. On the other hand, if you wish to be much less involved our scientist can carry out the entire project with your outlined goal in mind. Once the development is completed prevalidation will allow our scientist to determine whether the assay’s final format is ready to pass validation.
Typically there are no surprises during the prevalidation analysis. Once the assay is ready for validation, a protocol will be written and submitted to you for approval. Frequently there will be a small section citing the history of the project which our scientist — will help you to undertake while you are reviewing the protocol. During this time the SOPs and batch records will be written. The formal project manager will be assigned with the research associates. Typically they are the same individuals who develop the assay and are familiar with it.
Once the laboratory work commences plan on about two weeks for the ELISA, to about 1-2 months for a cell based assay. For immunoassays the time line around 2-3 week period, since primary cells are utilized. Marin Biologic has a registry of blood donors it successfully uses for its immunoassay. After validation data and a report will be delivered to you after a QC review. Any changes you wish to make happen at this juncture and final regulatory QA review is undertaken prior to issuing the final report. The validation report can be customized to your format.
Central Laboratory
Marin Biologic has experts as a central laboratory performing assays on our client’s pharamacokinetic samples and human clinical samples. We interface with individual clinical sites or your clinical studies director to receive samples. We will arrange with your clinical studies director to have a chain of custody form ready. We need a hard copy and an excel copy of the samples ID numbers/letters as the number is frequently in the multi hundreds or low thousands. We will discuss with you how the samples will be analyzed. Some clients want all samples from the same project including the pre-dose sample to be analyzed together at one time. Marin Biologic is a custom laboratory and will accommodate your requests and needs with uncompromised scientific quality.
For drug release assays, if available, one lot of drug will become the gold study against which all future lots will be measured for assay development and validation. If no gold standard is available then 2 lots will be used.
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