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.
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 portfolio | Featured services | Applications | Capabilities |
| Antibody Conjugation | Antibody-Drug Conjugate | Targeted cancer therapy, precision medicine | Antibody 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 Conjugate | Therapeutic RNA delivery, gene silencing | ||
| Peptide Conjugation | Peptide-Drug Conjugate | Peptide-based drug delivery, enhanced therapeutic efficacy | |
| Peptide-RNA Conjugate | mRNA therapy, targeted delivery to specific cells | ||
| Oligonucleotide Conjugation | Antibody-Oligonucleotide Conjugate | Targeted delivery of oligonucleotides to specific cells | |
| Peptide-Oligonucleotide Conjugate | Enhanced stability and targeted delivery of oligonucleotides | ||
| GalNAc-siRNA Conjugate | Liver-targeted gene silencing, treatment of hepatic disorders | ||
| Cholesterol-Conjugated siRNA | Improved cellular uptake and distribution of siRNA | ||
| Drug Conjugation | Protein-Drug Conjugate | Targeted drug delivery, enhanced therapeutic effects | |
| Aptamer-Drug Conjugate | Targeted drug delivery using aptamer targeting | ||
| Hapten-Carrier Conjugate | Immunization, antibody production against haptens | ||
| Liposome Conjugation | Aptamer Liposome Conjugate | Targeted drug delivery using aptamer-liposome complexes | |
| Peptide Liposome Conjugate | Enhanced drug encapsulation and delivery via peptide-liposome interactions | ||
| Fluorescent Labeling | Fluorescent Labeling of Nucleic Acids | Nucleic acid detection | |
| Stable Isotope Labeling | Stable Isotope Labeling of Amino Acids | Protein 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