Bioconjugation creates new molecules with increased stability and improved targeting. The process of joining proteins, peptides, or oligonucleotides to synthetic elements has produced drug conjugates that are more effective and less toxic than traditional drugs, such as antibody-drug conjugates (ADCs) and peptide-drug conjugates (PDCs). There are currently 11 FDA-approved ADCs and six PDCs.[i] From the latest market reports, a significant expansion is anticipated for the bioconjugation market, with a 15.6% annual growth rate propelling it from USD 5.27 billion in 2024 to USD 10.86 billion by 2029.[ii]
These new therapies can be used to detect diseases earlier, target tumours more effectively, and create new biomaterials for implantable devices. Treatments for diseases such as cancer, Alzheimer’s, and Duchenne’s muscular dystrophy (DMD) are all set to improve dramatically thanks to bioconjugate drugs.
These treatments can significantly reshape the healthcare landscape. Therefore, it is crucial that drug developers find expert partners. These partners must be capable of managing the intricate nature of these sensitive molecules. Furthermore, they must facilitate effective scale-up. This will ensure that more patients gain access to life-saving treatments.
How bioconjugates transform treatment
Alongside creating new treatments for some of the world’s most prevalent and previously incurable diseases, bioconjugates also offer more targeted delivery, better immune stimulation, and an improved half-life compared with other drugs. Additionally, bioconjugation can produce new drug conjugates that are more potent than traditional drugs, as well as more selective. Bioconjugate vaccines are also becoming a powerful approach to generate a stronger and longer-lasting immune response.
Essential to the optimisation of bioconjugates are pharmacodynamics (PD) and pharmacokinetics (PK) studies. PD probes how bioconjugates interact with specific biological targets and provides insight into molecular recognition and therapeutic response. PK, on the other hand, covers aspects such as absorption, distribution, metabolism, and elimination to uncover the bioconjugate’s journey within the body.
Developing a comprehensive understanding of PD and PK goes hand in hand with drug development. It is crucial for formulating precise designs and accurate safety assessments, helping new drugs achieve clinical approval sooner.
ADCs and PDCs are two drug variations that have emerged as a result of innovation in bioconjugation. These conjugates represent a significant advancement in targeted drug delivery and could revolutionise cancer treatment. Combining the specificity of antibodies or peptides with the potency of cytotoxic payloads, these conjugates aim to deliver potent drugs directly to diseased cells. A prime example of the benefit of peptide conjugation in drug development is Lutathera, a peptide receptor radionuclide therapy where a somatostatin analogue is linked to a radioactive isotope to specifically target neuroendocrine tumours, showcasing improved efficacy and reduced systemic toxicity. This approach minimises off-target effects and improves therapeutic outcomes.
PDCs are now being used to improve diagnostics, with tumour-homing peptides allowing an operator to visualise a tumour in real-time. Furthermore, the new practice of theranostics utilises PDCs to produce an effective, targeted, image-guided therapy. PDCs therefore represent a milestone in cancer treatment that could be revolutionary if deployed at scale.
Challenges in scaling bioconjugates
However, the principal obstacle to bioconjugates such as PDCs becoming standard treatment is the complex production process. The creation of bioconjugates requires the modification of cysteine residues, the incorporation of unnatural amino acids, and the use of enzymatic approaches – methods that require expert design and precise control. Experienced scientists can optimise the bioconjugation process for each molecule to ensure the highest possible yield to help customers develop bioconjugation processes for new or existing products.
To achieve optimal results in drug development, bioconjugation strategies should be integrated from the project’s inception if the drug is to benefit from enhanced properties, including improved targeting, increased stability, and the ability to deliver therapeutic agents to specific cells or tissues. This is particularly relevant in polymer chemistry, where the availability of tailored amphiphilic polymers for R&D and GMP-compliant manufacturing can be a limiting factor in drug delivery applications. By considering bioconjugation early, researchers can proactively design molecules with desired pharmacokinetic and pharmacodynamic profiles, potentially leading to more effective and less toxic drugs.
Efficient scale-up of bioconjugate synthesis and manufacturing is critical for successful drug development. This requires proactive planning, including bioconjugation process optimisation to maximise yield and quality, development of robust analytical methods for characterisation and quality control, and access to manufacturing facilities capable of GMP production for clinical trials and commercialisation, with production ranging from microgram to multi-gram scale.
A trusted partner in bioconjugates
Biosynth is a leading provider of raw materials that have advanced drug development across the pharmaceutical industry. Its state-of-the-art manufacturing facility in Berlin is equipped to produce high-quality bioconjugates at a range of scales. Boasting an experienced team with extensive expertise in developing and manufacturing bioconjugates, Biosynth can develop and perform bioconjugation processes from µg to multi-gram scale, and at early development stages all the way to the manufacture of an investigational medicinal product (IMP) or drug substance for first clinical trials in humans.
With a proven track record in the development of bioconjugates and extensive experience in chemistry and biologics to carry on modification of biologics with polymers/PEGs or small molecule drugs, Biosynth is familiar with all varieties of bioconjugation methods, including PEGylation and glycoconjugation, as well as with small molecule or peptide coupling.
Its scope explores a range of conjugation strategies, screening various reagents (such as different PEGs), and preparing test samples for in vitro or in vivo testing at customer sites. With an emphasis on the need for tailored, efficient, and scalable approaches to cater to the unique requirements of each biomolecule, Biosynth’s focus is on delivering high-quality bioconjugates through customised processes, the optimisation of individual steps, and the designing of scalable purification methods.
To find out how Biosynth can accelerate your bioconjugate development programme, download the free report below.
End-to-end support
Biosynth excels in the development and manufacturing of advanced bioconjugates, conjugate vaccines, and specialised polymers, providing comprehensive services from initial feasibility studies to GMP-compliant manufacturing. They offer tailored solutions for PEGylated biomolecules, conjugate vaccines, and custom amphiphilic polymers, addressing the critical need for specialised materials in drug delivery and biomolecule analysis. Their expertise spans all stages of bioconjugate development, including PEGylation, glycoconjugation, and small molecule coupling, with flexible manufacturing scales and adaptable quality levels. Recognising the challenges of bioconjugation, they prioritise the development of robust, scalable manufacturing processes, including purification and analytical method development, ensuring efficiency, consistency, and high-quality bioconjugates.
Addressing the limited availability of tailored amphiphilic polymers, particularly for GMP-compliant human use, Biosynth specialises in custom synthesis and GMP manufacturing. They provide end-to-end support for bioconjugate projects, from exploring conjugation strategies and screening reagents to manufacturing investigational medicinal products for clinical trials. Their experienced teams bring scientific knowledge in chemistry and biologics to optimise and scale manufacturing processes, ensuring that each bioconjugate meets the unique requirements of the project. They prioritise tailored, efficient, and scalable approaches, providing comprehensive services that address the complexities of bioconjugation and polymer development.
To find out how Biosynth can optimise your bioconjugate development, download the free report below.
[i] https://pmc.ncbi.nlm.nih.gov/articles/PMC10417123/ https://academic.oup.com/nar/article/53/D1/D1476/7808507
[ii] Research and Markets, Bioconjugation Market by Product (Consumables, Instruments (Chromatography, Spectrometry)), Service (Conjugation, Analytical), Technique (Chemical, Click Chemistry), Biomolecule (Antibodies), Application (Therapeutics (ADC), R&D) – Global Forecast to 2029
