Formulation Process Development
Biological drugs have complex structural components, functions, and complicated production processes. In addition, biologics have many instability factors, such as physical degradation like denaturation, aggregation, adsorption; and chemical degradation like deamidation, oxidation, hydrolysis. Factors affecting the stability of biologics including molecular structure, production process, and raw material quality, which, if not properly considered, can easily lead to biodegradation of toxicity, inactivation, immunogenicity, etc. Many pharmacologists have applied a variety of advanced biologic formulation techniques to deliver stable, safe, and effective products, to address degradation issues arise during production, to develop easy-to-use dosage forms, and to determine the appropriate pharmaceutical packaging materials and excipients that can increase the stability of biologic drugs. BOC Sciences always prioritizes the interest of our customer and does our best to meet their needs. Our formulation development platform is stable and efficient that allows us to develop formulations for water injection, pre-filled and freeze-dried powder. Our professional formulation team can quickly and efficiently identify protein-specific formulations for each project and thoroughly evaluate the stability of the target protein in the developed formulation.
Figure 1. Formulation selection process for compounds with potential issues of availability for absorption. (Branchu, S.; Rogueda, P. G.; et al. 2007)
Our Services
To make it easier and better for researchers, BOC Sciences provides formulation development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. We support a range of formulation development services for liquid and lyophilized drug product dosage forms for biopharmaceuticals. BOC Sciences has proven track record of helping our clients in fast formulation and process development for the successful drug application submission
Preliminary Formulation Development for Drug Candidates
- Pre-formulation design, candidate developability assessment; and candidate selection support
- Design of experiments (DoE) for determining the formulation of water injection
- Rapid automated high-throughput formulation screening
- Early stage formulation development
- Late phase formulation and process development
- Significant, relevant physicochemical properties studies
- Stability-indicating assays for major degradation products
- Long-term and accelerated stability studies: In-use stability (simulated administration testing)
- Inhalation drug product testing:Nebulizer screening for inhalation formulation
Formulation Optimization
- Data-driven approach based on results from preliminary characterization
- Pointedly-address critical quality attributes
- Large molecule liquid formulation development and pre-filled syringe studies
- Package materials selection and their compatibility evaluation: Selection of drug packaging materials, drug compatible stability studies, container-closure system selection and qualification
- Batching and filling process-related process development (dilution method, mixing effect, aseptic filtration, filling process parameters)
- Assessment of raw material and excipient quality
- Process scale-up and technology transfers
- Analytical testing technologies and solutions
- Extractable & Leachable testing for pharmaceutical container-closures
- Manufacturing of pre-clinical and clinical-stage drug product
- High concentration formulations Development
Lyophilized Formulation Development
- Lyophilization cycle optimization
- Appearance of the lyophilized cake optimization
- Rapid and thorough reconstitution
Drug Product Manufacturing Support
- Long-term and accelerated drug product stability studies according to ICH guidelines
- Technical transfer and scale-up support for clinical and commercial drug product manufacturing
- Regulatory support
- Commercial formulation and IP competitiveness, finalize presentation
- Drug product manufacturing process setup, design and process development: Selection of unit operations and process ranges, selection of processing materials such as disposable tubing and filters and process development and characterization
Figure 2. QbD, risk management and quality management in formulation development. (Kan, S.; Lu, J.; et al. 2014)
Instrument & Equipment
- Rheometer
- Particle testing (HIAC, flowcam, DLS) HIAC flowcam
- Circular dichroism spectrum
- Osmometer
- Differential scanning calorimeter
- Constant temperature and humidity chambers
- Lighting chambers
- HPLC、UPLC、LC-MS
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of formulation development at competitive prices for global customers. Personalized and customized services of formulation development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
References
- Branchu, S.; Rogueda, P. G.; et al. A decision-support tool for the formulation of orally active, poorly soluble compounds. European Journal of Pharmaceutical Sciences. 2007. 32: 128-139.
- Kan, S.; Lu, J.; et al. A quality by design (QbD) case study on enteric-coated pellets: Screening of critical variables and establishment of design space at laboratory scale. Asian Journal of Pharmaceutical Sciences. 2014. 9( 5): 268-278.
