BOC Sciences, as a global leading biopharmaceutical service platform, relies on a strong research team and a comprehensive GMP production system to provide a one-stop solution for ADC formulation development, covering the entire process from early-stage research to commercialization. Through long-term project accumulation and technological iteration, we have built a complete technical system covering multiple dimensions, such as analytical characterization, stability evaluation, release kinetics monitoring, lyophilization process development, and toxicity prediction. Each tool is not only efficient on its own but also seamlessly integrates with other modules, providing clients with more scientifically sound and feasible formulation development paths.
BOC Sciences provides precise conjugation technology and efficient purification to tackle formulation complexity from non-site-specific conjugation, optimizing ADC uniformity, stability, and quality control.
BOC Sciences optimizes DAR, drug structure, and coupling strategy to reduce instability caused by hydrophobic drugs, enhancing high-concentration formulations and long-term storage stability.
Expert in cleavable and non-cleavable linkers, BOC Sciences selects the ideal linker strategy and optimizes storage conditions and release mechanisms to improve formulation stability and therapeutic consistency.
With advanced antibody screening and conjugation design capabilities, BOC Sciences customizes formulations based on antibody characteristics to meet ADC delivery and stability requirements in specific indications.
In the ADC development pathway, formulation development is not only a key step in achieving drug release and biocompatibility, but also an essential part throughout the product lifecycle. In response to the complexity of ADC structures and the diversified functional needs, BOC Sciences has established a one-stop ADC formulation development service system that covers everything from early research to later industrialization. Supported by a highly integrated and modular technical platform, we help clients rapidly transition from laboratory exploration to clinical trials and commercial production stages.
Based on antibody configuration, linker type, and payload characteristics, BOC Sciences systematically screens and designs the most suitable initial formulation solutions for each ADC. Using high-throughput experimental platforms and molecular modeling technologies, we quickly optimize core parameters such as pH, ion concentration, buffer systems, and excipient types.
BOC Sciences has established a professional excipient screening database and conducts systematic compatibility studies on excipients with antibodies, linkers, and small molecule toxins. Common excipients such as sucrose, mannitol, arginine, and polysorbate are subjected to rigorous stress testing, aggregate detection, oxidation degradation evaluation, and cell compatibility verification.
ADCs are highly sensitive to pH, osmotic pressure, and redox environments. BOC Sciences customizes suitable buffer systems for each project. Whether based on phosphate, acetate, or histidine systems, we accurately assess their stability under various storage conditions using DSC, DLS, UV-Vis, and other methods.
To address the early release of payloads in in vitro environments, BOC Sciences has built a stability database covering different chemical structures of linker ester bonds, peptide bonds, sulfur ether bonds, etc., and has developed various stabilization strategies, such as adding specific protectants, optimizing the antioxidant environment, or adjusting pH to delay enzyme activity.
To meet the different storage and transportation conditions required for clinical trials and commercialization, BOC Sciences offers parallel development pathways for liquid and lyophilized formulations. We have an advanced lyophilization process platform, providing full support from freeze curve development, protectant screening, to lyophilization process scale-up.
In line with international stability research standards, BOC Sciences conducts accelerated and long-term stability testing under multi-gradient conditions, comprehensively evaluating key indicators such as appearance, pH, particle size, purity, residual solvents, and biological activity, and establishing stability trend charts to guide shelf life predictions and packaging design.
To ensure that the ADC product quality is not compromised during transportation and storage, BOC Sciences offers a full set of packaging material compatibility testing services, including the impact of syringes, stoppers, glass vials, and infusion systems on ADC components, including adsorption, migration, and degradation.
From laboratory-scale formulation optimization to pilot-scale upscaling and GMP batch preparation, we are equipped with cGMP-compliant filling workshops, filling lines, and lyophilization systems. We can meet the requirements of different stages to complete clinical sample production, process validation, and regulatory sample delivery.
Integrates automated liquid handling and microplate screening technology to quickly evaluate buffer systems, excipients, and pH combinations, improving the efficiency of early-stage formulation decision-making.
Uses various analytical techniques such as SEC-HPLC, DLS, CE-SDS, MS, DSC, and TGA to evaluate the physical, chemical, and biological stability of ADCs.
Combines pH-simulated release models and LC-MS/MS technology to accurately assess the release rate and target dependency of drugs from linkers.
Provides full-process services from lyoprotectant screening to sublimation curve design, ensuring the integrity of antibody and drug activity during long-term storage.
Uses bioinformatics algorithms and in vitro simulation systems to identify potential immune responses and excipient toxicity risks in advance, optimizing safety design.
For GMP batch samples, formulation verification data, process transfer documentation, and quality audit support are provided, assisting customers in successfully passing clinical filing and registration reviews.
In Antibody-Drug Conjugates (ADC), the buffer is a solution system used to maintain the pH stability of the solution. The buffer prevents significant pH fluctuations during storage and use, ensuring that the structure and efficacy of the ADC are not compromised. Common buffer components include phosphate, acetate, and chloride salts, which help maintain the stability of the antibody and drug carrier, optimizing the drug's bioavailability and therapeutic effects.
The production of Antibody-Drug Conjugates (ADCs) generally involves several steps: first, the antibody is produced through recombinant technology; then a suitable drug molecule is synthesized or selected; the drug is subsequently conjugated to the antibody via a linker. Finally, the completed ADC undergoes purification, characterization, and stability testing to ensure quality standards are met. The ADC is then processed into its final form, either as a lyophilized or liquid formulation, for clinical use.
A typical ADC formulation mainly includes five components: 1) the ADC itself, which is the antibody-drug conjugate; 2) excipients, such as sucrose or mannitol, to enhance stability; 3) a buffer system, commonly phosphate or acetate, to maintain pH stability; 4) a surfactant, such as polysorbate 80, to prevent protein adsorption and aggregation; 5) other additives like EDTA, a metal ion chelator, to prevent metal-catalyzed degradation.
Common lyoprotectants and excipients used in ADC lyophilized formulations include sugars (trehalose, sucrose, glucose), polyols (mannitol, sorbitol), amino acids (glycine, histidine), surfactants (polysorbate 20/80), and buffering agents (sodium acetate, histidine buffer). These components help improve the stability after lyophilization and preserve the structural integrity of the protein upon reconstitution.
Protectant screening should be based on the properties of the drug, starting with initial formulations such as 10% trehalose, 9% sucrose, and 5% sorbitol. When combining two protectants, their concentrations are typically halved. Samples are stored at 4 °C, 25 °C, and 40 °C for 14 days, then evaluated by visual clarity, BCA concentration assay, SEC-HPLC purity, DSC thermal stability, and CIEF pI profile shifts to identify and optimize the best formulation components and concentrations.
