by Background
Bioprocess validation is an extremely crucial component in bioprocessing to ensure product quality and consistency across every batch. Due to the complex and sensitive nature of biological manufacturing, it is essential to thoroughly validate each step in production to eliminate variability. A robust validation program is therefore necessary for biomanufacturers to comply with regulatory requirements and gain approval for new products.
Process Development and Documentation
During process development, extensive documentation is created to fully characterize each unit operation. Bioprocess Validation Operating parameters like media composition, pH, temperature, agitation rates are optimized to achieve maximum yield and quality attributes. Critical process parameters (CPPs) that could influence the final product are identified through design of experiments and risk assessments. This design space is used to establish in-process control (IPC) and online monitoring strategies. Detailed standard operating procedures (SOPs) and batch records incorporate these parameters and controls. Analytical methods are also validated to ensure reliable measurement of product qualities.
Facility and Equipment Qualification
Once the manufacturing process is defined, the facilities and equipment involved must be qualified. This includes qualification of utilities like water, steam, gases and qualification of cleaning procedures. Equipment such as bioreactors, centrifuges and filters are qualified by demonstrating repeatability and capability to achieve product specifications. Computer systems controlling manufacturing are validated for integrity of data generated. Environmental controls for air handling and isolators are qualified to maintain appropriate conditions.
Process Validation
Process bioprocess validation is then conducted to prove the process is capable of consistently delivering quality product meeting predefined standards. Several validation batches covering the whole manufacturing process are executed under close monitoring. In-process and release testing are done to check product attributes match pre-defined acceptance criteria. Any issues identified are thoroughly investigated and Corrective and Preventive Actions (CAPA) are implemented. A validation report summarizing results of all validation batches is submitted to regulatory bodies to gain approval for commercial production under regulated conditions.
Continued Process Verification
Even after initial bioprocess validation, the process must be continually monitored through commercial manufacturing to ensure state of control. Parameters of ongoing production batches are checked against pre-defined control limits through statistical process control methods like real time release testing. Any deviations are thoroughly reviewed and appropriate actions are taken. Periodic revalidation may also be conducted to ensure no drift in performance over time due to factors like equipment ageing or material attrition. This continued verification provides assurance that the process remains in a state of control.
Process Changes and Revalidation
Changes to any aspect of the validated process like raw materials, equipment, facilities, analytical methods or SOPs require revalidation to applicable extent unless a change evaluation justifies otherwise. Even minor changes are carefully controlled to prevent any inadvertent impact on product quality. Based on the nature and potential criticality of the change, a varying degree of revalidation activities like product testing, process runs, equipment qualification may be necessary. A scientific and risk-based approach is warranted for evaluating and implementing changes while maintaining product integrity.
Comprehensive bioprocess validation provides objective evidence that biomanufacturing processes are capable of consistently meeting all CQAs within pre-defined operating space. It helps ensure product quality and reduces process related failures and rejections. Rigorous validation and continued monitoring give regulators confidence in approved processes. With recent advances in analytics, real-time process control and quality by design approaches, validation practices continue to evolve enabling more efficient and agile manufacturing to serve patients
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
About Author - Ravina Pandya
Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. With an MBA in E-commerce, she has an expertise in SEO-optimized content that resonates with industry professionals. LinkedIn Profile
