cGMP Bioconjugation Manufacturing

cGMP Bioconjugation Manufacturing

Currently, the demand for various bioconjugates in the pharmaceutical industry is high, particularly for antibody drug conjugates (ADCs). As a CRO providing comprehensive bioconjugation services, BOC Sciences has developed a bioconjugation platform for Good Laboratory Practice (GLP) studies and the use of validated systems and Good Manufacturing Practices (GMP) for the production of bioconjugates.

cGMP Bioconjugation

Bioconjugation is a chemical process that links two molecules, at least one of which is a biomolecule such as a carbohydrate, nucleic acid, or protein. Recent advances in biochemistry have enabled the development of more efficient bioconjugation reactions, including bioorthogonal reactions, ketone and aldehyde modification reactions, N- and C-terminal modification, and labeling-site selectivity. These bioconjugates can be used for a variety of purposes, including cellular tracking, imaging biomarkers, and targeted drug delivery.

cGMP Bioconjugation Manufacturing

The manufacture of bioconjugates is a complex process that must comply with cGMP (Current Good Manufacturing Practice) to ensure the safety and consistency of the bioconjugates. Starting with the parent molecule, through the generation of the conjugates and ending with the purification of the bioconjugates, cGMP is used throughout. cGMP bioconjugate manufacturing involves the use of specialized equipment and materials to ensure the high quality and purity of the final product.

BOC Sciences provides comprehensive conjugation services for research and development of bioconjugates. Our conjugation purification lines can perform hundreds of liters of conjugation reactions, providing the flexibility to meet the production needs of our global partners.

Custom Bioconjugation

BOC Sciences specializes in the development of novel bioconjugates, and we offer a one-stop solution for our customers. From conjugation method design, compound synthesis, to bioconjugate manufacturing, we provide high quality services throughout the process.

Bioconjugation portfolioFeatured servicesApplicationsCapabilities
Antibody ConjugationAntibody-Drug ConjugateTargeted cancer therapy, precision medicineAntibody drug development, antibody sequencing, mass production and humanization of antibody by cGMP;
Design and screening of oligonucleotide sequences;
Design and validation of targeted peptide sequences;
Small molecule drug development and small molecule screening;
Quality studies and scale-up process development;
Cell drug screening, pharmacological evaluation, PK, PK/PD, DMPK;
cGMP pilot production;
Proteomics and metabolomics.
Antibody-siRNA ConjugateTherapeutic RNA delivery, gene silencing
Peptide ConjugationPeptide-Drug ConjugatePeptide-based drug delivery, enhanced therapeutic efficacy
Peptide-RNA ConjugatemRNA therapy, targeted delivery to specific cells
Oligonucleotide ConjugationAntibody-Oligonucleotide ConjugateTargeted delivery of oligonucleotides to specific cells
Peptide-Oligonucleotide ConjugateEnhanced stability and targeted delivery of oligonucleotides
GalNAc-siRNA ConjugateLiver-targeted gene silencing, treatment of hepatic disorders
Cholesterol-Conjugated siRNAImproved cellular uptake and distribution of siRNA
Drug ConjugationProtein-Drug ConjugateTargeted drug delivery, enhanced therapeutic effects
Aptamer-Drug ConjugateTargeted drug delivery using aptamer targeting
Hapten-Carrier ConjugateImmunization, antibody production against haptens
Liposome ConjugationAptamer Liposome ConjugateTargeted drug delivery using aptamer-liposome complexes
Peptide Liposome ConjugateEnhanced drug encapsulation and delivery via peptide-liposome interactions
Fluorescent LabelingFluorescent Labeling of Nucleic AcidsNucleic acid detection
Stable Isotope LabelingStable Isotope Labeling of Amino AcidsProtein structure studies, mass spectrometry analysis

Why Choose BOC Sciences’ Bioconjugation?

At BOC Sciences, we have developed comprehensive expertise in all process steps related to cGMP bioconjugation manufacturing. Our team of experienced scientists is dedicated to providing the highest quality bioconjugates. We use qualified and monitored facilities, as well as qualified analytical equipment to analyze and characterize bioconjugates. We are committed to meeting the highest quality and safety standards for cGMP bioconjugation manufacturing.

  • We have the ability to develop and execute bioconjugation processes from micrograms to several kilograms in scale.
  • We use a variety of conjugation chemistries including reductive amination, activated esters or carbonates, thiol-reactive groups, click chemistry, and enzymatic conjugation.
  • We utilize size exclusion chromatography, reversed-phase high performance liquid chromatography, ion exchange chromatography, affinity chromatography, ultrafiltration and other separation and purification methods.
  • Our laboratory is equipped with temperature-controlled reaction blocks, high capacity reactors, chromatography systems, freeze dryers, laminar air flow systems, and a manufacturing suite cleanroom.

cGMP Manufacturing

  • Quality control measures, such as testing and inspection
  • Proper documentation and records
  • Professional equipment and trained personnel
  • Products are produced in a safe and consistent manner and in accordance with defined standards
* Please kindly note that our services can only be used to support research purposes (Not for clinical use).
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