Unit Operations
Quality Assurance & Quality Control in Biopharmaceutical Processes
Quality assurance (QA) and quality control (QC) are an essential foundation to the safety and regulatory compliance of biopharmaceutical product production. Through a combination of these two systems, and by making them a priority within your organization, you can ensure the highest quality and safety of product according to regulatory compliance or guidelines, while maintaining optimal yield and cost savings.
What are quality assurance (QA) and quality control (QC)?
What is quality assurance?
Quality assurance is a proactive system of processes, guidelines, and requirements, designed to work within a company’s larger quality management system (QMS). This can include standard operating procedures, document control, quality training, regular auditing, and redundancy checks.
What is quality control?
Quality control is a reactive system of controls that ensures a product's safety and design, and can include spot and material checks, inspections, product testing, and manufacturing review. QC works in tandem with QA by verifying that the processes that QA puts in place are effective through tests of the final product.
Why is it important?
Because of how variable, complex, and specific biopharmaceutical and biological systems and materials can be, quality assurance and quality control are tantamount to ensuring safe practices and use for patients of these products. A defective product can create significant and considerable safety risks.
Organizations such as the Food & Drug Administration (FDA) and European Medicines Agency (EMA), that are responsible for the evaluation of drugs, biologics, medical devices, and more, provide regulatory requirements that depend on QA and QC systems to be robust and proactive.
Good Manufacturing Practices and Good Laboratory Practices
Good manufacturing practices (GMP) and good laboratory practices (GLP) are requirements provided by international regulatory bodies whose aim is to constantly improve quality through betterment of documented guidelines, training, informed practices, and enforcement actions. Quality control and quality assurance within an organization play a key role in ensuring that these requirements are met.
The scope of GMP and GLP includes requirements for qualified and trained personnel, acceptable facilities and equipment, maintained and calibrated equipment, validated processes, documentation, clearly written instructions and procedures, reliable testing laboratories, suitable storage and transportation, sanitation, complaint handling, and overall quality-oriented mindset across the organization.
Prioritizing quality using process analytical technology (PAT)
Process analytical technology (PAT) are instruments that help you understand your process, sample behaviors, and product composition. By integrating PAT throughout the workflow, continuoous monitoring and elimination of manual intervention is possible, which in turn reduces contamination and sterility risk, as well as reliance on costly, off-site testing that may delay your process by days or even weeks. With PAT, users can access rapid measurements immediately in the lab, allowing for snap decisions and adaptability to unpredictable product quality attributes.
PAT works hand-in-hand with quality assurance and quality control, ensuring that you always have a wide viewpoint of your process and insightful data to act upon, without suffering the delays of off-line testing. With process analytics, you can anticipate delays and pain points in advance, and automate your process while putting parameters and checkpoints in place, by having the technology and capability to adapt on the fly.
PATsmart Solutions
We are dedicated to providing our customers with the most cutting-edge technology that meets exacting standards of regulatory agencies. Where many times, there is guesswork or approximations, PAT gives you immediate, actionable results across your upstream and downstream workflows.
Technology You Can Trust
Repligen’s offering of instruments spans across the workflow and is dedicated to supporting our customers, with revolutionary solutions and tireless service that support and reinforce quality standards and practices.
Our upstream solutions ensure you treat precious biologic material with care. We offer analytical instruments that can rapidly separate critical quality attributes (CQAs), so you can achieve rapid protein characterization and metabolomic analysis using charge variant analysis, intact mass analysis, peptide mapping, and reduced/subunit analysis.
Identify amino acids and nutrient profiles, and monitor glucose, lactate, and total biomass to optimize feeding strategies and keep your cell cultures happy and healthy.
Our downstream solutions utilize variable pathlength technology (VPT), a UV-Vis spectroscopy method based on Beer’s Lambert law that drastically reduces sample preparation and analysis time, contamination risk, and need for dilution.
The advances of Slope Spectroscopy® have been recognized in publications, like the ASTM Standard Practices for General Techniques of UV-Vis Quantitative Analysis, and in many major biopharmaceutical labs, as a trusted partner in saving significant time, resources, and costs in Quality.
Minimizing Variability Through Closed-Loop Systems
Automate your process by integrating PAT into your tangential flow filtration (TFF) workflows! With KrosFlo® Real-Time Process Management (RPM®), you can combine the continuous protein measurements of the FlowVPX with a lab- or production-scale TFF system, and control filtration through automation, custom setpoints, and recipe features of the KrosFlo RPM Software.
