Frequently Asked Questions

Once a confidentiality (CDA) or non-disclosure agreement (NDA) has been executed, you will work with our project operations team to establish the developmental services agreement. Next, we would review the protocol, develop the contract and pricing for the study, and assign your project team which includes a dedicated Principal Investigator, Project Coordinator, and Project Assistant.

Upon execution of the final contract, samples are sent to MicroConstants and analyzed per the timeline specified in the contract. The preliminary data is sent through quality control (QC). The QC'd data is then released to the client and we begin creating the report. Reports are audited by our Quality Assurance Unit (QAU), if applicable, and the draft is then submitted to the client for review. After review, client comments are incorporated to create the final report.

We assign a dedicated Project Coordinator and Principal Investigator to every project. Your Project Coordinator will serve as the main point of contact throughout the duration of the study. They will work with you to develop a project execution plan, provide you with continuous status updates, and monitor the progress of each project to ensure that timelines are being met. Your dedicated Principal Investigator will interpret, analyze, document, and report all project results, and work with our analysts to troubleshoot any problems that may arise. They will also collaborate with you and the study site(s) to ensure the protocol is being followed and the samples are correctly analyzed and reported.

Depending on the complexity of the compound, assay development typically takes three to five days, and validation requires an additional two weeks. For immunoassays, development will usually take one to three weeks, and validation will require an additional two to three weeks (not including long term stability).

Reports are typically finalized within five days of receiving the sponsor's comments depending on the complexity and quantity of the comments.

No. If a contract is signed with MicroConstants in San Diego the samples will be analyzed at our San Diego facility. If a contact is signed with MicroConstants China the samples will be analyzed at our Beijing facility.

We are not licensed to handle radioactive materials; nevertheless, we do work with exempt quantities. To inquire about your specific situation, please contact us.

Yes. We can analyze U.S. DEA Drug Schedules II, III, IV and V (U.S. DEA controlled substance drug scheduling list).

Yes. Long-term sample storage is available in the following conditions: frozen (-20^oC or -70^oC), refrigerated, or room temperature. To inquire about pricing for long-term sample storage, please contact us.

Yes. We were successfully audited by the USFDA in 2001 and in 2005. If you would like specific details on these audit findings, please contact us.

Since 1998, we have been audited more than 100 times. We welcome all of our clients and potential clients to tour our facilities and audit the quality systems we have in place. If you would like to arrange a time to visit our facility, please contact us to schedule a site visit.

MicroConstants is in compliance with the following regulatory agency guidelines:

• United States Food and Drug Administration (USFDA), Title 21 Code of Federal Regulations Part 58, Good Laboratory Practices (GLP)
• Organisation for Economic Co-operation and Development (OECD), Principles of Good Laboratory Practices (GLP) [ENV/MC/CHEM (98)17]
• Japanese Ministry of Health, Labor and Welfare (MHLW), Good Laboratory Practice Standards (GLP Ordinance 21)

Yes. Your method will transfer to a Waters LC/MS/MS system at MicroConstants with little to no modification. In many cases, lower limits of detection will be achievable when properly optimized on the Waters system.

A method which has been previously validated can typically be transferred to MicroConstants without any additional redevelopment costs. Some non-GLP methods may not be fully optimized for your compounds; however, the cost of development would typically be reduced if a previous method is available.

Yes. The information and results generated from drug metabolism studies conducted at MicroConstants is regularly incorporated into IND and NDA submissions.

At this time, the FDA does not require in vitro metabolism assays to be conducted under GLP regulations, so our analytical methods have not been validated. However, our assays are always conducted according to our Standard Operating Procedures (SOPs) which are carefully designed to be compliant with USFDA Guidance. These studies are typically not reviewed by our Quality Assurance Unit (QAU), but all drug metabolism studies performed at MicroConstants are fully documented so they are as traceable as any GLP study.

When developing and validating methods for formulations, MicroConstants evaluates the following parameters: specificity, carryover, linearity, homogeneity, interday and intraday accuracy and precision, and stability including freeze/thaw, room temperature, refrigerated, and frozen stability. A typical validation includes storage stability out to 30 days; however, extended stability can also be evaluated as a separate project.

The amount of compound required is based on the concentration range to be validated. Since QC formulations are prepared as part of the validation, high concentration formulations will require more material. To inquire about your specific compound, please contact us.

Prior to beginning a formulation validation project, the following information will need to be provided:

• Vehicle composition and preparation
• Dose range to be validated
• Correction factor to be used at the toxicology facility
• Salt form and structure of the test article
• Any unusual steps planned for the preparation of the formulation (i.e. mixing overnight, dropwise additions, etc.)
• Planned storage conditions

If any of these changes from one study to the next, additional validation work may be required for subsequent studies. Therefore, we recommend that the initial validation parameters are broad enough to account for likely alterations.

MicroConstants will need approximately 50 mg of reference standard along with a Certificate of Analysis/Testing. If you do not have a Certificate of Analysis (COA), or you have an old COA, we can generate an audited COA for your API or internal standard to be used for the method validation.

We highly recommend using a stable labeled internal standard; however, we can use an analog standard as an internal standard if required.

Most kits can be validated for GLP studies, but there are instances where certain kit components may require modification in order to optimize the assay for validation. However, there are some commercially available immunoassay kits that are not able to be validated for GLP studies for reasons ranging from lack of reference material to poor performance.

Yes. MicroConstants can assist you in locating the appropriate antibodies for your protein/peptide. In instances where antibodies are not commercially available, we will contract a custom antibody production facility to generate custom/novel antibodies against your protein therapeutic. Custom antibodies typically require two to three months to produce.

One week for domestic shipments and two weeks for international shipments.

Most countries will require either an import permit and/or an export permit. MicroConstants works with World Courier to ensure that any necessary permits are in place prior to the start of the study. Vendors other than World Courier can be used upon request; however, we strongly recommend using World Courier for all international kit shipments because of their expertise with cold chain shipments.

Samples can be returned to MicroConstants for samples analysis, but they can also be shipped to the testing facility of your choice. However, sponsors will receive a 20 - 30 percent discount on specimen collection kit supplies if MicroConstants performs the sample analysis.