One-stop Biologic Formulation Solution
In recent years, the development of biologics is extremely rapid, and biologics such as antibodies, ADCs, and vaccines are playing an increasingly important role in the treatment of many serious and chronic diseases that currently have no treatment. However, due to the complexity and sensitivity of biological macromolecules, the formulation of biologics requires special attention and expertise. At BOC Sciences, we provide one-stop biologic development services to develop stable biological formulation.
What are biologics?
Biologics process development
In contrast to most pharmaceutical substances with well-defined chemical properties and known structures, most biologics are complex mixtures that are not easily characterized. Biological macromolecules are large and unstable, and are usually administered parenterally. Protein stability is the main starting point for the design and development of biopharmaceuticals. For biological products, the formulation process development is usually divided into three stages: pre-prescription research, prescription research and process development. As specialists in pharmaceutical formulations, BOC Sciences offer formulation development,fumulation stability research, preclinical testing services, regulatory support, etc.
Our one-stop biologic formulation solution
Biologic pre-formulation study
| Service | Description |
|---|---|
| Pre-formulation | It includes biochemical analysis of biomacromolecules, amino acid sequencing, establishment of analysis methods for stability indexes, and analysis of biophysical properties under pH and ionic strength. |
| Under different conditions of temperature, pH and ionic strength, the solubility and stability of the drug were investigated to select the suitable buffer liquid system. | |
| Drug stability experiments are done by assessing chemical stability of molecules at different temperatures, humidity and light conditions. We investigated the aggregation, precipitation, gelation and denaturation of biological macromolecules, their physical stability was examined and optimized. Freeze-drying is widely used to improve the stability of biological macromolecules, so freeze-drying must be evaluated for feasibility and stability. When designing the prescription system, the stability of the drug needs to be tested under long-term and accelerated conditions. | |
| Screening and optimization of the excipients like the selection of the correct buffers, surfactants, sugar protectants, and antioxidants. Drugs and excipients could interact to influence chemical, absorption and stability of drugs. Therefore, it is necessary to study the compatibility of drug and excipient. |
Formulation development services
The common dosage forms of biologic drugs mainly include injection and freeze-dried powder injection. In addition, in recent years, new preparation technologies such as liposomes, microspheres, and nanoparticles have been gradually applied in the drug delivery system of biologics to improve the stability and bioavailability of drugs.
Biologic characterization
For biosimilar analysis
We also provide
Biologics classification at BOC Sciences
Our facilities
- Biologics and Bioassays
- Biomarkers
- Mass Spectrometry
FAQ
Biologics are drugs prepared by biotechnology or genetic engineering, including vaccines, monoclonal antibodies, recombinant proteins, etc.
Biologics tend to be larger molecules, with greater complexity, complex structure and production techniques-cell culture, fermentation, etc.
Biological agents have high molecular weight, easy degradation, and are sensitive to temperature, light, pH and other factors. It is often necessary to develop suitable buffers, freeze drying, and other protective measures to improve drug stability and meet patient use needs.
The vast majority of biologics need to be cold chained into place and transported to stay stable and active. Also needed for biologic drugs that are sensitive to temperature, cold chain transport needs to be managed between 2-8 °C.