Quality Controls
Biologics are a very complex class of drug products due to the fact that biological molecules are inherently more complex, often not easily characterized, and the manufacturing process is more complex. Moreover, most biologics are made in cell culture and, therefore, these products are more likely to be contaminated with foreign agents such as viruses, mycoplasma and other transmittable pathogens. Control of product quality depends on the use of selected raw materials and careful adherence to strict manufacturing processes. Quality control procedures often include: prevention of accidental contamination, inactivation/removal. Due to the complex molecular structure of biological drugs, functional activity assays are often required to identify which structures are more or less potent. BOC Sciences provides comprehensive analytical and microbiological quality control services during all drug development projects.
Figure 1.Overview of quality testing in the Remicade manufacturing process. (Melsheimer, R.; Calmann, M.; et al. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides quality controls 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. BOC Sciences has established reliable procedures to evaluate all GMP areas and processes to ensure continuous control
Cytotoxicity Testing
At BOC Sciences, sterility testing, bioburden testing and endotoxin testing are routinely performed in-house. The focus and scope of analytical services depends on the client/project requirements
Microbiology Testing
BOC Sciences provides comprehensive analytical and microbiological quality control services in all pharmaceutical development programs including microbiological analysis of pharmaceutical products, medical devices, raw materials and packaging. Quality controls services are performed in accordance with a current, audited quality system
Stability Testing
Stability testing is performed under controlled conditions in accordance with ICH guidelines. Our well-designed stability testing services include stability studies for drug substances, drug products and buffers, conditions for accelerated stability studies, controlled cabinets for stability studies - storage conditions according to ICH guideline
Examples of Quality Controls aqnalyses:
- Characterization, potency, safety and purity analysis: Protein analysis, potency analysis, cell-based analysis and purity/purity analysis
- Pharmacopeial analysis
- Product-specific validation for microbial quality control and safety analysis: Sterility testing, bioburden testing and endotoxin testing, bacterial lesion/fungal lesion testing
- Stability study capabilities
- Study planning, analytical quality control testing and reporting
- Qualified and validated methods for environmental monitoring and testing, product release and GMP stability testing in compliance with ICH standards
- Environmental monitoring
- High purity water testing
- Product release testing
- Reagent qualification and validation
- GMP manufacturing support
- In-process testing
- Reference standard creation, characterization and qualification testing
Figure 2. Overview of the Remicade manufacturing process. (Melsheimer, R.; Calmann, M.; et al. 2018)
Quality Control Laboratory
- High performance liquid chromatography systems
- Densitometers
- Plate washers and readers for ELISA testing
- In vitro whole cell bioassays
- Capillary electrophoresis equipment
- Spectrophotometers.
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 quality controls at competitive prices for global customers. Personalized and customized services of quality controls 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
- Melsheimer, R.; Calmann, M.; et al. Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade (R). BioDrugs: Clinical immunotherapeutics, biopharmaceuticals, and gene therapy. 2018. 32: 405-414.
