Manufacturing and Quality Assurance
This lab encompasses 10,000+ square feet of space and houses both – our primary production labs as well as the quality control lab.
An Emphasis on Reproducibility and Quality
We have established control procedures that ensure highest quality standards for goods released to our customers. Products are manufactured in our laboratory by well-trained staff using state-of-the-art technology. Amongst others, this lab contains:
- ISO Class 7 / 8 Cleanrooms to avoid bio-contamination
- Air Handling Units that cover all manufacturing spaces
- Automated ELISA coating and production lines
- Semi-Automated processes for other steps including washing, blocking etc
Our ELISA kits are thoroughly validated to ensure they meet the highest quality standards. Krishgen ELISA follow the US FDA / EMA ICH M10 bioassay guidelines for bioassays and are tested for the following factors:
• Matrix Validation
• Sensitivity
• Specificity
• Intra-assay precision
• Inter-assay precision
• Recovery
• Linearity of Dilution
• Parallelism
• Cross Validation with known International Standards, where available or with Innovator Drugs
• Accelerated Stability Study
Data acquired from these validation tests are available in each kit’s IFU or separately as Validation Guide for the product. If you have any queries or require further information, please connect with us at sales@krishgen.com
FDA India License |
AEO (Authorized Economic |
ISO:13485 JAS:ANZ |
ISO 13485 |
We Are Registered / Certified for the following:
– CE IVD
– Mumbai Customs Authorization for Privately Run Customs bonded Warehouse
– LTU status (Large Tax Paying Unit) Status by Government for GST (Goods & Services Tax)
Optimization is: “an (act, process, or methodology of making something such as a design, system, or decision) as fully perfect, functional, or effective as possible.”
Validation is: “an act, process, or instance of validating especially: the determination of the degree of validity of a measuring device.”
Standardization is: “to bring into conformity with a standard especially in order to assure consistency and regularity … to compare with a standard: to determine the strength, value, or quality of (something) by comparison with a standard.”
ELISA most often serves to measure the presence or quantity of antibodies or antigens, or biomolecules in general which can be recognized by antibodies. In biological matrices (such as serum, plasma, blood, urine and saliva) ELISA is an important diagnostic tool used to detect various antigens and antibodies. Indirect or direct ELISAs are used in medical product development, particularly for testing vaccines and new drugs. ELISA with specific antibodies can be designed to measure impurities within the medical products resulting from the production process. Antibody assays against these impurities should also be developed and validated for testing the levels of the impurities, which should be kept at a minimum in order to avoid adverse immune responses. For immunogenic substances with expected low concentrations, such as cytokines, hormones, toxins etc., sandwich ELISA is used.
Irrespective of the ELISA design (indirect, direct or sandwich), OVS principles are the same. Of paramount importance for any bioanalytical method is that it is well characterized, fully validated and documented to a satisfactory standard in order to yield reliable results.
Validated analytical methods such as ELISA for quantification of biomarkers, drugs, biological products, and their metabolites in a given biological matrix (e.g. blood, plasma, serum, or urine) are critical for the successful conduct of nonclinical and clinical studies. Validating the analytical method ensures that the data are reliable. Validated methods provide critical data to support the safety and effectiveness of drugs and biological products.
Although there is abundant literature relating to immunochemical methods, EMEA and US FDA have clearly defined the characteristics of the validation procedure for bioanalytical methods, which also applies to the validation of ELISAs, which are intended for use in diagnostics, toxicology, basic or applied research or production control. Methodology for the validation of bioanalytical methods must follow clear recommendations from reference institutions such as the EMEA or the WHO because that provides important measurements to be of satisfactory quality all over the world.
ELISA validation according to these recommendations means determining the following method characteristics:
1. Specificity
2. Linearity – Range - Limit of detection (LOD)
3. Sensitivity
4. Accuracy
5. Precision (repeatability = intra assay, inter assay, reproducibility = inter laboratory assay)
6. Robustness
Acceptance criteria should be prospectively defined based on the intended use of the method.
Learn more about our validation here:
ELISA manufacturing as is well known is an art backed with principles. Our production process are controlled by state of the art instrumentation and documentation at every stage to ensure that we offer quality assays with the minimal lot-to-lot variability.
QC Process Built-In:
Raw Material Controls - all raw materials are stringently controlled with SDS page records to ensure there is low noise in our assays and are stored with aliquots correctly with data-logged, cloud-based real-time storage refrigeration.
In-Process:
Be it plate coating, conjugation, standard preparation, and secondary reagents manufacturing - all the steps are benchmarked with internal controls and documents to ensure there is minimal downtime in optimization of our production lots.
Liquid Handling:
All our bulk liquid handling is automated to ensure that there is minimal human operator error, and a high level of accuracy is maintained for reproducible results.
Boxing, Packing and Documentation:
All kits are boxed with two level checks, photographed online with all components for our production records and stored in our cloud base servers. All production lots are recorded in our Batch Manufacturing Record offline and online in our system for future retrievals.
The efforts of our continuous improvement QC Process is to ensure that we constantly strive to see that you get the best quality product from us.