Developability Assessment
To develop a candidate into a drug, pharmacologists need to evaluate many properties of biologics, such as expression and purification yields, aggregation propensity, stability, viscosity, physicochemical profile, compatibility with the in vivo environment, and immunogenicity. Therefore, balancing biology and exploitability to select the best molecule is a critical step in the successful development of a biologic drug. Developability assessment reduces risk and increases the likelihood that the selected biologic drug candidate will be successfully deve oped into a patient-ready drug. BOC Sciences have abilities in providing comprehensive developability assessment services for your biopharmaceutical drug candidates, and our goal is to establish the process to yield the optimal outcome in a cost-effective manner.
Advantages of developability assessment
- Improve efficacy and safety
- Focus on the most promising drug candidates
- Maximize the output of R&D investment
- Reduce cost and time to market
- Improve product quality
Figure 1. Developability assessment. (Lorenz, T.; Beach, A. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides developability assessment 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.
- Clone selection: Mass spectrometry based multi-attribute monitoring (Seq, PTMs), glycan profiles
- Manufacturing/scaling up: Sequence analysis, PTMs, glycan profiles, disulfide bonds, higher order structures, drug-derived impurities, aggregates, process-derived impurities, HCPs, critical quality attributes (CQA), bioassays to address efficiency issues
- Manufacturing feasibility assessment: Productivity, stability, aggregation
- Formability of specific routes of administration
- Compatibility with the in vivo environment: Immunogenicity, off-target effects, and half-life
- In silico sequence analysis
- Host codon optimization
- Plasmid design and construction
- Enlarged
- Molecule stability evaluation
Figure 2. Example of a classical, sequential liquid chromatography method development process, testing individual method parameters. (Lorenz, T.; Beach, A. 2018)
Analysis methods
- Post-translational modifications
- Identification of potential post-translational modification hotspots that may impact drug development through systematic sequence analysis
- Identification of potential PTM sites (e.g. isomerization, deamidation, oxidation, glycosylation, etc.) by experimental methods such as LC-MS
- Analysis of physical and chemical properties
- Expression titer estimation by transient transfection
- Integrity verification and common modifications analysis by LC-MS
- Aggregate characterization by SEC-HPLC
- Isoelectric point determination and charge heterogeneity analysis by CEX or iCIEF
- Thermal stability analysis by DSF
- Stability analysis
- Thermal stability analysis
- Photostability
- Oxidative stability analysis
- Freeze-thaw stability analysis
Developability assessment process
At BOC Sciences, we have introduced a QbD (Quality by Design) strategy to carry out developability assessment:
- Preliminary screening
- Manufacturability assessment
- Immunogenicity assessment/In-vivo fitness assessment
Figure 3. Example of design space method development approach for Liquid Chromatography. (Lorenz, T.; Beach, A. 2018)
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 developability assessment at competitive prices for global customers. Personalized and customized services of developability assessment 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!
Reference
- Lorenz, T.; Beach, A. Analytical strategies for developability assessment of therapeutic proteins. American Pharmaceutical Review. 2018. 21(4).
