Guarantee Efficiency & Accuracy With Our Quality Control Laboratory
Our Quality Control (QC) lab is equipped with top-of-the-line technology, and our trained personnel are always working to ensure that the products produced by Andelyn Biosciences are safe, meet desired quality metrics, and are suitable for use in clinical settings.
The QC Lab contains general laboratory space and an additional separate microbiology lab space in a controlled access area. The Quality Control group completes in-process and release testing for all PD, VVC and GMP productions.
Using our quality control laboratory, we ensure the production of accurate, reproducible, and reliable results when developing AAVs for gene therapy and other products. We use the latest best practices and meet all relevant regulatory requirements for QC at Andelyn Biosciences – providing our clients with peace of mind that their projects are being handled with the care and attention they deserve.
Andelyn Bioscience QC Lab Testing Capabilities Include:
- General tissue culture
- Viral infectivity assays
- Protein and DNA electrophoresis
- Western blotting
- Mycoplasma detection
- Filter integrity (bubble point) testing
- Incubation and analysis of microbiological environmental monitoring samples
- Bioburden testing
- Sterility testing
- Digital Droplet PCR under development
Additional testing capabilities through partnerships with contract labs include:
- Analytical ultracentrifugation analysis
- Plasmid and viral DNA sequencing
- Host cell protein quantification
- Host cell DNA quantification
- Bovine and porcine viral detection (CFR 9)
- Detection of wide range of viral agents (through qPCR and RT-qPCR)
- In-vitro/vivo detection of adventitious agents
Potency or expression assays are to be conducted and reported by the sponsor or designee, with filled product to be provided by the QC lab. Product will be shipped using either FedEx or World Courier with a temperature monitor and Chain of Custody documentation.
We Minimize & Handle Deviations To Guarantee Product Quality
We follow a full suite of standard operating procedures to avoid analytical errors and deviations, and ensure accurate results from all assessments that are done at our facility.
- Pre-analytical errors – We avoid pre-analytical errors by ensuring proper sample collection methods are followed, and always following proper procedures while storing, handling, and preparing samples for processing and testing.
- Analytical errors – Analytical errors are avoided by properly maintaining and validating all equipment, following QC standards and procedures, and employing only the most skilled QC technicians and lab personnel at Andelyn Biosciences.
- Post-analytical errors – We avoid manual calculations after analyses to minimize post-analytical errors, and use modern analytical processes and reporting steps to properly document the results of each and every test.
Why Use Andelyn’s QC Lab? Understanding The Benefits
Whether you’re working with Andelyn to create a new AAV or gene therapy treatment, or you simply wish to outsource QC to our team after manufacturing a biopharma product elsewhere, there are a number of reasons we're the best choice.
- Unbeatable quality testing services – As touched upon above, we use the latest equipment and best practices, as well as highly-trained staff and well-established processes and procedures at our quality control laboratory, providing excellent results.
- Reliable turnaround times – We will always provide timely testing within the quoted time frame. When it comes to scheduling, you can trust our QC lab to deliver results with reliable, fast turnaround times.
- LIMS and QMS – We use both a Laboratory Information Management System (LIMS) and Quality Management System (QMS) to track every aspect of quality control testing for transparency and peace of mind.
Contact Our QC Lab To Get Started Today
Andelyn Biosciences is standing by to help you test your biopharma products. To learn more and get started, contact us online to speak to a representative and discuss your project in further detail.
What We're Currently Working On
The QC Lab also performs Stability Testing, Dose Confirmation Testing, Device Compatibility Testing, Vector Comparability Testing and other custom testing in support of GMP or Toxicology studies. Any additional testing, including stability testing, will be carried out under a separate proposal. Stability studies can be performed at the Toxicology or GMP level. Device Compatibility, Vector Comparability, or Dose Confirmation Studies are typically performed at the Toxicology level, with all documentation peer reviewed and the final report signed by Quality Control.
The QC Lab is currently developing additional assays and capabilities. Methods under development include host cell protein quantification by ELISA and host cell DNA quantification by ddPCR. New equipment currently being qualifying or in development include the Nano-S particle sizer, the BioRad ddPCR system, Perkin Elmer LabChip GXII Touch, and the Pall FlowStar IV filter integrity check system.