Custom Conjugation


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Elevate your research with Columbia Biosciences’ custom conjugation and reagent development services

Are you seeking consistent and reproducible solutions for your research needs? Columbia Biosciences is proud to offer a reagent development service designed to meet your needs for antibody and protein labeling. We offer a comprehensive range of services, spanning from individual conjugation projects to complete reagent development packages.

Columbia offers a wide range of options for your labeling project

Functional Target Possibilities:

  • Immunoconjugates (Whole and Reduced IgG antibodies)
  • Proteins/Peptides
  • Nucleic Acids
  • Small Molecules (Fluorescent Dyes, Biotin)
  • Microparticles
  • Functionalized Polymers

Examples of Common Conjugation Partners:

  • Fluorophores
  • Small Molecules
  • Proteins
  • Enzymes
  • Oligonucleotides

Examples of Available Conjugation Chemistries
Targeted Groups:

  • Amines (Succinimidyl ester, Isothiocyanate)
  • Carboxylic acids (Carbodiimides)
  • Thiols (Maleimides, Haloacetimides)
  • Aldehydes (Hydrazines/Hydrazides, Reductive Amination)
  • Carbohydrates
  • Bioorthogonal (Tetrazine ligation, CuAAC and SPAAC)
  • Fc site specific labeling

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Why choose Columbia Biosciences for your next custom conjugation?

  • Rapid turnaround time – 10-14 days, expedited 7 day service also available
  • Consistent and reproducible – detailed batch records & QC testing to ensure successful scale-up
  • Wide range of experience including fluorescent dyes, enzymes, drugs, proteins, haptens, oligos, and PEG
  • Flexible – we provide custom conjugation services for both research and commercial applications
  • Experienced team – over 20 years of antibody and protein conjugation experience
  • Documentation – Certificate of Analysis for every custom conjugate includes concentration, F/P ratio and fluorometry
  • Scale up capabilities – milligram to gram scale
  • Trusted Partner – Custom conjugation service provider to most of the largest pharmaceutical companies
  • Streamlined Workflow – Our goal is to make it as easy to order from us as it is to order from Amazon

What makes a great conjugate?

A good antibody/protein conjugate shows specificity by binding selectively to its target antigen while minimizing nonspecific interactions for accurate detection in complex samples. It demonstrates high sensitivity for detecting low antigen concentrations, crucial for low abundance targets. Stability is essential to maintain functionality under varied storage conditions, resisting temperature fluctuations, pH changes, and degradation. Efficient conjugation ensures optimal labeling without compromising specificity, while minimal background signal enhances signal-to-noise ratio for precise detection. Consistency, user-friendly protocols, and rigorous validation processes guarantee reliable results, crucial for research and diagnostics.

See our whitepaper for more information on what makes a great conjugate.

Our services range from single conjugations to comprehensive reagent development projects

Columbia offers a comprehensive range of services, spanning from individual conjugation projects to extensive antibody reagent development endeavors. Whether you require a single conjugation for a specific application or seek to embark on a complete reagent development project, we’ve got you covered. Our expertise extends across the entire spectrum, ensuring meticulous attention to detail and optimized performance at every stage. Whether it’s tailoring conjugates for unique assays or undertaking large-scale reagent development initiatives, we deliver customized solutions to meet your precise needs. With our versatile capabilities, personalized approach, and commitment to excellence, we are your trusted partner for all antibody-related endeavors, no matter the scale.

 

Research Use
Custom conjugation services are often used for experimental purposes in research laboratories and academic institutions. Researchers may require custom-labeled antibodies or other biomolecules for various experiments, such as immunofluorescence, flow cytometry, or Western blotting. These experiments are aimed at elucidating biological mechanisms, investigating disease pathways, or validating new drug targets. Custom conjugation services allow researchers to tailor labeling strategies to their specific experimental needs, ensuring accurate and reliable results.
Critical Reagent
In some cases, the labeled biomolecules produced through custom conjugation services serve as critical reagents in diagnostic assays, therapeutic formulations, or manufacturing processes. These reagents play a central role in the functionality and performance of the final product. The reliability and quality of these critical reagents are essential for ensuring the accuracy and effectiveness of diagnostic assays or therapeutic interventions.
Incorporation into Product Line
Custom conjugation services are also used manufacturers looking to incorporate labeled biomolecules into their product lines. These products may include assay kits, reagents, or diagnostic devices used by researchers, clinicians, or laboratories. By outsourcing custom conjugation to specialized service providers, companies can ensure the efficient production of high-quality labeled biomolecules tailored to their specific product requirements.
FDA Cleared Diagnostic
Custom conjugation services are crucial for the development and production of FDA-cleared diagnostic tests used in clinical settings for disease diagnosis, prognosis, or monitoring. These diagnostic tests must undergo rigorous validation and regulatory approval processes to ensure their safety, efficacy, and accuracy. Custom-labeled antibodies or other biomolecules are integral components of these diagnostic tests, serving as capture or detection reagents. Columbia is ISO13485 certified for medical device manufacturing.

 

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We can guide you through the development process based on the unique needs of your project

Steps of the development process

Determine End Use: The process begins with a clear definition of the requirements and objectives for the reagent, including its intended application, target molecule or pathway, performance criteria, and regulatory considerations. This step lays the foundation for subsequent stages of development.

End Uses
Research UseCritical ReagentIncorporation into Life Science Products (OEM)FDA Cleared Diagnostic
Stage 1
Probe Selection
Conjugation
Characterization
Optimization
Reagent Selection
Stage 2
Pilot Scale Production & Scale Up
Stability Studies
Aliquoting
Bottling
Labeling
Freeze DryingOptional
Stage 3
Documentation
Auditing
Regulatory Compliance

Probe Selection: When selecting a probe for an antibody conjugate, it’s crucial to consider specificity to the target antigen, ensuring minimal nonspecific binding. High affinity enhances detection sensitivity, while compatibility with conjugation chemistry ensures stable coupling. Probe size and structure should suit the intended application, like immunofluorescence or immunohistochemistry. Additionally, factors such as cost, availability, and licensing requirements need to considered.. Careful evaluation of these factors ensures optimal performance and reliability in the desired application.

Conjugation: Precision is vital during the conjugation step to effectively attach the antibody or protein to the desired molecule. This involves activating functional groups on both the antibody and the molecule, then linking them covalently. Different conjugation chemistries are used based on the molecules involved, with careful optimization of pH, temperature, and reaction time to ensure specific coupling while maintaining antibody functionality. Purification steps remove unreacted molecules, ensuring the purity and effectiveness of the final conjugate.
Examples of Available Conjugation Chemistries
Targeted Groups:

  • Amines (Succinimidyl ester, Isothiocyanate):Chemistries targeting amino groups, commonly used for antibody labeling and bioconjugation.
  • Carboxylic acids (Carbodiimides):Reactions involving carboxylic acid groups, facilitating coupling to primary amines for conjugation.
  • Thiols (Maleimides, Haloacetimides): Reactions targeting sulfhydryl groups, employed in protein labeling and crosslinking applications.
  • Aldehydes (Hydrazines/Hydrazides, Reductive Amination):Chemistries targeting aldehyde groups, useful for labeling carbohydrates and glycoproteins.
  • Carbohydrates:Functional groups on sugars and carbohydrates, utilized in glycoconjugate synthesis and carbohydrate-based drug delivery.
  • Bioorthogonal (Tetrazine ligation, CuAAC and SPAAC): Chemistries enabling selective conjugation in complex biological systems without interfering with native biomolecules.
  • Fc site specific labeling: Targeting specific sites on antibodies for conjugation, ensuring controlled orientation and functionality.

Characterization: The reagent undergoes rigorous characterization to assess its purity, identity, stability, and functional properties. This may include analytical techniques such as spectroscopy, chromatography, mass spectrometry, and biological assays.

End Uses
Research UseCritical ReagentIncorporation into Life Science Products (OEM)FDA Cleared Diagnostic
Physical Characterization
Incoming Raw Material Inspection Amount /Concentration (spectrophotometry)
Incoming Raw Material SEC HPLC (Purity and Aggregate content)
Degree of Labeling
Concentration
Purity
Labeling Distribution – Mass spectrometry
Characterization of Activity (Pick Most Relevant)
Cell-based assays/Flow Cytometry
SPR
ELISA

Optimization: Based on the results of the characterization step, optimization of conjugation protocols is carried out to improve yield, purity, and performance. Variables such as antibody concentration, coupling chemistry, and reaction conditions are systematically fine-tuned to achieve optimal conjugate yield while preserving antibody functionality. Through rigorous optimization, the antibody conjugate can be tailored to meet the specific requirements of its intended application, maximizing sensitivity, specificity, and stability.

Pilot Scale Production & Scale Up: Once the reagent has been validated and quality-controlled, scale-up procedures are implemented to produce larger quantities for commercialization or distribution. Manufacturing processes are optimized to ensure scalability, cost-effectiveness, and consistency of product quality. Columbia produces quantities at the milligram to gram scale for both research and commercial applications.

Aliquoting, Bottling, Labeling, Freeze Drying: In critical development, aliquoting, bottling, labeling, and freeze-drying are vital for stability, reproducibility, and usability. Aliquoting divides the reagent into smaller volumes to reduce freeze-thaw cycles and maintain consistency. Bottling preserves the reagent, shielding it from contamination and degradation. Labeling provides essential information for documentation and tracking. Freeze-drying removes water, creating a stable, long-lasting product. These steps optimize production and distribution, ensuring reliability across various applications.

Stability Studies: For long term stability testing, you can rest easy in the knowledge that your samples will be kept within the target temperature range. Columbia monitors all of its temperature chambers remotely using sensors in each unit.

Documentation: Detailed documentation is prepared, including standard operating procedures (SOPs), specifications, certificates of analysis (CoA), and other documentation as required.

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