Frequently Asked Questions
Below are responses to some of the questions commonly asked by our clients and potential clients. If you have any additional questions about BioAgilytix or our services, please contact us.
What is the study process at BioAgilytix?
- 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 BioAgilytix 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.
- 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
- 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 BioAgilytix 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)
Method Development and Validation
Can we transfer methods directly to BioAgilytix 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 BioAgilytix?
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.
Drug Metabolism (DMPK) Assays
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.
Dose Formulation Analysis
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.
Bioanalysis for Small Molecules
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.
Bioanalysis for Macromolecules
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 BioAgilytix 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.
Specimen Collection Kits
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 BioAgilytix?
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.
A Non-Traditional Internal Standard
The development of a nontraditional internal standard by derivatization allowed our client to maintain their rigorous timeline without resorting to an expensive synthetic effort.Read Full Case Study
Selective Extraction in Method Development
Employing selective extraction in method development enabled the accurate determination of in vivo drug concentration in plasma samples collected during our client’s Phase I trial.Read Full Case Study