Frequently Asked Questions About BioAgilytix

What is the study process at MicroConstants?

Confidentiality (CDA) or Non-Disclosure Agreement (NDA) is executed
Developmental Services Agreement (DSA) is established
Pricing proposal is prepared by our Project Operations Department based on the RFP and/or protocol for the project
Final contract is executed and your project team is assigned (dedicated Principal Investigator, Project Coordinator, and Project Assistant)
Samples are sent to MicroConstants and analyzed per the timeline specified in the contract
Preliminary data is sent through quality control (QC)
QC’d data is released to the client and report preparation is initiated
Report is audited by our Quality Assurance Unit (QAU), if applicable
Draft report is submitted to the client for review
Report is finalized and client comments are incorporated

Who will be our main point of contact?

Every client is assigned a dedicated Project Coordinator and Principal Investigator for their projects.

Project Coordinator:

Serves as the main point of contact throughout the duration of the project
Works with you to develop a project execution plan
Provides continuous status updates
Monitors the progress of each project to ensure timelines are being met

Principal Investigator:

Interprets, analyzes, documents, and reports all project results
Works with our analysts to troubleshoot any problems that may arise
Collaborates with you and the study site(s) to ensure the protocol is being followed and the samples are correctly analyzed and reported

How long will it take to develop and validate our assay?

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).

How long will it take to finalize our draft report once we have reviewed it?

Reports are typically finalized within five business days of receiving the sponsor’s comments (depending on the complexity and quantity of the comments).

Do you have the ability to analyze samples containing radioactive compounds?

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

Do you analyze controlled substances?

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

Can samples be stored at MicroConstants for an extended period of time?

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

Have you been audited by the USFDA for compliance with Good Laboratory Practices (GLP)?

Yes. We were successfully audited by the USFDA in 2012, 2005, and 2001. Our most recent inspection in September 2012 resulted in zero findings, observations, or recommendations. Learn more.

How often do you get audited by clients or potential clients?

Since 1998, we have been audited more than 140 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.

What regulatory agency guidelines do you comply with?

BioAgilytix 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)

Can we transfer methods directly to MicroConstants if they were previously developed on an LC/MS/MS platform not listed on your website?

Yes. Your method will transfer to a comparable LC/MS/MS system at BioAgilytix with little to no modification. In many cases, lower limits of detection can be achieved when properly optimized with proper optimization or moving to a more sensitive platform.

If we already have a method that was developed at another CRO, will we need to pay to have it redeveloped at MicroConstants?

A method which has been previously validated can typically be transferred to BioAgilytix, 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.

Has any of the drug metabolism data generated been used in regulatory submissions?

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

Are IC50 assays and other preclinical drug metabolism studies conducted in compliance with GLP regulations?

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 BioAgilytix are fully documented so they are as traceable as any GLP study.

What is included in a formulation validation?

When developing and validating methods for formulations, BioAgilytix 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.

How much material is required for a formulation validation?

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.

What information do we need to provide for a formulation validation project?

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.

How much compound is required for a bioanalytical method validation?

BioAgilytix 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.

What kind of internal standard will we need for bioanalytical method validations?

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

Can commercial immunoassay kits be validated for use in GLP studies?

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.

Can MicroConstants develop our immunoassay if we do not have antibodies for our protein/peptide?

Yes. BioAgilytix 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.

What is the turnaround time for kits once the request has been submitted and the contract executed?

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

Are there any special requirements for international shipments?

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

Do samples have to be analyzed at MicroConstants?

Samples can be returned to BioAgilytix for bioanalytical and/or pharmacokinetic analysis, but they can also be shipped to the testing facility of your choice. A discount may be applied to kit orders when sample analysis is performed at BioAgilytix.

What is BioAgilytix?

What is a CRO (Contract Research Organization)?

What bioanalytical laboratory services does BioAgilytix provide?

What is pharmacokinetics?

What is pharmacodynamics?

What is the most common method of bioassay?

What is an immunoassay?

What is a bioassay?

What is immunogenicity?

What is biomarker testing?

What is a neutralizing antibody (NAb)?

What are anti-drug antibody (ADA) assays?

What is gene therapy?

What do biotech companies do?

What does potency mean?

What is assay development?

What is cellular therapy?

What is toxicity assay?

What is cell migration assay?

What is CAR-T cell therapy?

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San Diego, CA 92121

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Brisbane Laboratory

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Queensland, 4102, Australia

USA HQ

2300 Englert Dr

Durham, NC, 27713

919-381-6097

Fax 919-381-6099

San Diego Laboratory

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

Brisbane Laboratory

37 Kent St,Woolloongabba

Queensland, 4102, Australia

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

+61 3 9282 2184

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

+61 3 9282 2184

Durham Lab (USA HQ)

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099

Morrisville Lab

5927 S. Miami Blvd. Suite 100
Morrisville, NC 27560
919-381-6097
Fax 919-381-6099

Boston Lab

1320 Soldiers Field Road

Boston, MA, 02135

Office 617-456-0700

Fax 617-456-0701

San Diego Lab

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

Hamburg Lab (EU HQ)

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Brisbane Lab

37 Kent St, Woolloongabba

Queensland, 4102, Australia

Melbourne Lab

85 Commercial Road, Melbourne

Victoria, 3004, Australia

03 9282 2184

Durham Lab (USA HQ)

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099

Morrisville Lab

5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099

Boston Lab

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

San Diego Lab

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Brisbane Lab

37 Kent St,Woolloongabba

Queensland, 4102, Australia

Melbourne Lab

85 Commercial Road, Melbourne

Victoria, 3004, Australia

03 9282 2184

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