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In Vitro Diagnostics (IVD)
In Vitro Diagnostics (IVD) stands as a groundbreaking frontier in modern healthcare, facilitating the precise and timely detection, management, and monitoring of diseases. At the core of IVD advancements lies recombinant proteins and antibodies, which have completely transformed diagnostic accuracy and specificity. Recombinant technology enables the creation of exceptionally pure and consistent proteins and antibodies, devoid of the variations and impurities typically encountered in native extractions. These recombinant proteins and antibodies empower IVD tests with unmatched sensitivity, rendering them indispensable tools in the diagnostic field.
With the increasing demand for fast, dependable, and consistent diagnostics, the utilization of recombinant proteins and antibodies has expanded across a range of applications. Some common uses are as follows:
- Immunoassays:
Antibodies are commonly used in immunoassays, including lateral flow assays, Western blotting, and enzyme-linked immunosorbent assays (ELISA). These tests help identify and measure target analytes, such as proteins, antibodies, or antigens. - Point-of-Care Testing (POCT):
POCT devices use proteins and antibodies for quick, on-site diagnostic testing. These tests are intended to yield instant results, allowing healthcare professionals to act fast in urgent situations with limited resources. - Disease Screening and Diagnosis:
Proteins are often used in screening tests for early diagnosis of diseases, such as cancer, infectious diseases, and autoimmune disorders. These tests support the detection of a specific condition or help identify patients at risk. - Companion Diagnostics:
These tests are often used alongside therapies to identify patients likely to respond to a particular treatment or monitor treatment effectiveness. - Quality Control and Standardization:
In manufacturing IVDs, proteins and antibodies are crucial for QC. To ensure the accuracy, precision, and reproducibility of diagnostic tests across batches and labs, proteins and antibodies are employed as reference materials, calibrators, and controls. - Therapeutic Monitoring:
Proteins and antibodies are often used in therapeutic intervention monitoring, including medication-level monitoring, treatment-response evaluation, and illness progression or remission evaluation. These tests help optimize therapy and adjust dosages. - Detection of Biomarkers:
Antibodies and proteins can be used to find biomarkers in patient samples (e.g., blood) to diagnose and monitor diseases. Some of these biomarkers include proteins, hormones, enzymes, antibodies, and genetic markers.
Protein and Antibody Production for IVD Applications
We offer a range of protein and antibody production services for clients in the In Vitro Diagnostics field. To learn more about how our capabilities can meet your IVD needs, please see our services below.
Monoclonal Antibody Production
A cost-effective, ultra-HTP antibody production platform that uses 96- and 24-well DWP format, resulting in a daily throughput of 1000x antibody production at 100 μg-1,500 μg per antibody, suitable for in vitro assays.
An antibody production service that can provide antibodies that are low on endotoxin (<0.5 EU/mg) and aggregates (>95% monomer) at the scale of 1-100 mg, suitable for both in vitro and in vivo studies.
Premium-quality monoclonal antibodies ranging from 1-100 grams in 3-4 weeks. Our platform synergizes ultra-high titer transient expression with flexible purification processes
Antigen Production
Powered by high-titer CHO and HEK293, our services offer speed and cost-effectiveness for transient expression and seamless scale-up for stable expression using CHO system.
We offer protein expression and evaluation of antigens, labels, tags, and chaperone proteins via our highly optimized fermentation platform. Co-expression of proteins and production and purification of other challenging biomolecules is also available.
Insect cell culture-based protein production services for the generation of proteins that are challenging to produce in prokaryotic or other eukaryotic systems or for proteins that require different glycosylation and other post-translational modifications compared to mammalian cell culture-derived proteins.
Case Study: High Titer and Low Endotoxin Production of Antibodies for IVD Application Using 7-7-7 Service
This case study demonstrates the production of monoclonal antibodies (hIgG1) and antibody fragments (his-tagged VHH, scFv and sdAb) with high purity and low endotoxin via the use of our 7-7-7 Service.
Figure A: A recombinant antibody (hIgG1) to be used in an IVD assay was expressed in a 40 mL culture using the 7-7-7 service. The SEC-HPLC analysis confirmed the antibody’s high purity (>99%) even after a free/thaw cycle. The high purity of the antibody was also evidenced via SDS-PAGE under both reduced and non-reduced conditions.
Figure B: The production of a HC-tagged scFv for an IVD application. The SEC-HPLC analysis indicates a purity of 96.5% for the scFv antibody fragment. The high purity is further corroborated by a clean single band observed in SDS-PAGE under both reduced and non-reduced conditions.
Frequently Asked Questions
Q: Does the His tag in Quick 'n' Clean interfere with internalization when made into an ADC?
A: While His tag typically doesn’t exhibit pharmacokinetics (PK) property, we always advise clients to exercise caution when using His tag with bispecific antibodies. Acute dosing shouldn’t present any issues. However, for chronic dosing over an extended period, such as 3 months, using double tags might increase the risk of adverse ADC events.
Q: In your Premium Bispecific Antibody Production service, you use Mass spec (MS) to determine homodimer percentage. Given that MS isn’t a quantitative technique, how do you achieve this?
A: Every molecule has its unique behavior. For example, the time-of-flight (TOF) efficiency of a half antibody can be 10X of the full-length antibody. So, if we observe a 1:1 ratio of half antibody to full-length antibody in LC/MS, it might represent half antibody only ~5% of the total mass. While this makes direct quantification challenging, the LC/MS still provides insight into byproducts in a non-quantitative way. Additionally, when comparing your target molecule to a homodimer, both often have similar molecular weight and similar TOF efficiency and this comparison is more quantitative than comparing half antibody with full-length antibody. In our Premium Bispecific Antibody Production service, concerns about half antibodies are minimal since we ensure their complete removal.
Related Content
- Webinars: Assessing Pharmacokinetics and Manufacturability in Early Biologics Drug Discovery and the other two webinars
- Brochure: Featured Services for Protein & Antibody Production
- Posters: Low Endotoxin & Low aggregates Antibody Production Using 777