Antibody Drug Formulation Development

In therapeutic areas ranging from cancers and infectious diseases to autoimmune diseases, antibody-based therapeutics have drawn tremendous attention owing to their high specificity and efficiency. BOC Sciences, one of the leading biopharmaceutical solutions companies, is developing and optimizing formulations of antibody drugs to enhance stability, efficacy, and patient compliance.

What is antibody drug?

Antibody drugs, otherwise known as monoclonal antibodies, are proteins engineered into the immune system to recognize and bind to specific targets on cells, whether these be cancerous or pathogenic. The therapies are fantastically targeted, hence, they are allowed to deliver their therapeutic effects precisely where needed, with minimal collateral damage to healthy cells. Along with the rise in biologics, antibody drugs have become key components of modern regimens of treatment.

Types of antibody drugs

Monoclonal antibodies (mAbs)

By design, monoclonal antibodies target only one antigen, hence providing specific treatment options. They can be given intravenously, subcutaneously, or in intra-muscular modes of administration, according to the formulation and depending on the patient's needs.

Antibody-drug conjugates (ADCs)

ADCs are the monoclonal antibodies conjugated with cytotoxic agents, which deliver drugs directly to the cancerous cells. This approach reduces the occurrence of adverse side effects; the drug is guaranteed to be released in normal cells. Revolutionary oncology therapy, ADCs have promising outcomes in cancers that were difficult to treat.

Bispecific antibodies (BsAbs)

BsAbs are designed to bind two different antigens at the same time, further enhancing therapeutic efficacy. They will be of particular use in immuno-oncology, where binding the cancerous cells and immune cells at the same time will provide a better immune response.

Our antibody formulation development services

Pre-formulation studies

Pre-formulation characterization forms the initial step in the direction of developing appropriate antibody formulations. Detailed studies of the physicochemical properties of antibodies—essential for ensuring success and stability—examine the foremost parameters: pH, stability, and solubility under various conditions.

pH: Antibodies have a working pH range at which they are stable in their structures and act effectively. BOC Sciences performs extensive pH profiling to find the optimal range of antibodies within each formulation.

Solubility: The profile of solubility of the antibody is critical to be understood. BOC Sciences uses state-of-the-art techniques to determine the solubility of the antibody at various concentrations and at different formulation conditions to make sure that the antibody is soluble under the intended conditions of storage and administration.

Stability: Stability studies investigate how temperature, light, and other environmental aspects affect antibodies. Accelerated stability testing is performed at BOC Sciences to predict long-term behavior under different formulation conditions.

Excipient selection

Every formulation needs to be well-chosen in excipient selection. BOC Sciences systemic screening finds excipients to improve the stability, solubility and performance of antibody preparations. The principal excipients can be categorised as:

Surfactants: Prevent aggregation, promoting stability.

Stabilizers: Guard against breakage in storage and handling.

Buffers: Keep pH balanced and and enhance solubility.

Osmotic agents: Prevent irritation at the time of administration.

pH adjusters: Fine-tune the formulation pH to desired levels.

Lyophilization protectants: Safeguard the antibody during freeze-drying.

Viscosity modifiers: Control formulation viscosity for ease of administration.

Antioxidants and chelating agents: Inhibit oxidative degradation, enhancing stability.

Preservatives: Prevent microbial growth, ensuring product sterility.

Strategies for choosing stabilizing agents

Selection of correct stabilizing agents, buffers, and preservatives is a critical step in building strong antibody formulations. BOC Sciences uses a rational excipient selection strategy which includes:

Compatibility studies: Detailed antibody compatibility studies determine the excipients that do not interact negatively with the therapeutic protein, and therefore maintain potency and efficacy.

Buffer optimization: Buffer systems are an important aspect of antibody stability and function. BOC Sciences studies different buffer mixtures to find the right balance for every individual antibody.

Formulation development

BOC Sciences develops formulations for monoclonal antibody injectables, lyophilized products, and ADCs. Our ADC formulation services include optimizing formulation and release kinetics to maximize therapeutic impact while minimizing toxicity. ADC stability studies define degradation pathways, optimize buffer systems, and establish batch-to-batch consistency.

Stability studies

The robustness of antibody formulations is evaluated by assessing both physical and chemical stability. BOC Sciences investigates stability-related factors through:

Long-term stability studies: By monitoring formulations over extended periods, these studies help identify degradation trends and inform necessary adjustments to the formulations.

Accelerated stability studies: These studies replicate prolonged storage conditions to predict shelf life and performance in real-world scenarios.

Toxicology, pharmacodynamics, and pharmacokinetics evaluation

To optimize antibody formulations for clinical use, BOC Sciences conducts comprehensive evaluations of toxicology, pharmacodynamics, and pharmacokinetics. These assessments are essential for understanding the therapeutic potential and safety profile of each antibody drug candidate, supporting regulatory submissions, and informing clinical trial design. Specific testing methods employed include:

Toxicology studies: In vivo and in vitro testing to evaluate the safety profile, including acute and chronic toxicity assessments, genotoxicity tests, and immunotoxicity evaluations.

Pharmacodynamics assessments: Techniques such as receptor binding assays and cellular response assays to measure the biological effects of the antibody and its mechanism of action.

Pharmacokinetics evaluations: Studies involving bioanalytical methods like LC-MS/MS for drug concentration measurements in biological samples, along with compartmental modeling to understand drug distribution, metabolism, and elimination.

Formulation manufacturing

The final step in developing antibody formulations involves transitioning from lab-scale to commercial production. BOC Sciences prioritizes scalability in formulation design to ensure the final product can be manufactured efficiently and consistently. Our team assesses the formulations for manufacturing suitability, focusing on process optimization and compliance with regulatory standards. This preparation guarantees that the antibody formulation is not only effective but also feasible for large-scale production.

Why choose BOC Sciences?

Proficient in custom formulation design: Custom solutions for monoclonal antibody, ADCs, and bispecific antibodies products.

High-tech test labs: Wide testing facility for tight quality assurance.

Compliance with regulation: Comprehensive documentation as per the international regulation requirements.

Collaborative approach: Close partnership with clients to address unique formulation challenges. With over 20 years of industry experience, BOC Sciences provides reliable, innovative solutions that help biopharmaceutical companies bring effective and safe antibody therapies to the market.

FAQ

1.What are the antibodies used by BOC Sciences?

Monoclonal antibodies, ADCs, and bispecific antibodies, as well as therapeutics in oncology and infectious diseases are specialisms of BOC Sciences.

2.Can BOC Sciences help to prepare lyophilized antibody products?

Yes, BOC Sciences provides formulation for lyophilized antibody products with lyoprotectants for stability and shelf life.

3.What are BOC Sciences' quality control arrangements?

BOC Sciences' quality assurance procedures include high-performance liquid chromatography (HPLC), mass spectrometry (MS), and size exclusion chromatography (SEC) for rigorous testing to ensure safety and efficacy of antibody formulations.