Validating Bioprocess Innovation to Exceed Regulatory Standards

July 16, 2020

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As bioprocessing innovation continues, drug manufacturers face many challenges. The market is demanding more targeted, efficacious, and cost-effective therapeutics, raising the stakes for drug manufacturers. Across the industry increasingly complicated biologics, biosimilars, and cell and gene therapies are driving innovation as patient populations grow and age. Interest in continuous bioprocessing and flexible facilities are also on the rise.


Drug manufacturers must identify efficacious products and manufacture them with processes that meet regulatory requirements. The United States and Europe have continued to tighten regulations and introduce new standards for validation of regulatory compliance. In Asia, particularly in China, there is a greater focus on advanced extractable and leachable (E&L) testing and validation, than in the past. This is due to the increasing interest and implementation of single-use systems, in biologics processing. 


As global regulatory bodies evolve safety and quality requirements, drug manufacturers must demonstrate that they are in a state of control of their processes. Clear validation plans (that support scale-up or scale-out processes) and documentation of demonstrated process validation success, must be readily available, during audits. These documents are especially important when working towards Phase III or commercial production phase. It is inherent to product lifecycle management (PLCM). 


Meeting Challenges with Responsible Solutions


Many new or improved bioprocessing processes, implemented by drug manufacturers involve challenging solvents or formulation recipes. For instance, with cell and gene therapies, the liposomal carriers are potentially harder to sterilize using sterilizing grade filtration. Or they can have issues that exacerbate under processing pressure. Using traditional sterilizing grade filters might require multiple stages of filtration. Drug manufacturers must overcome these challenges while demonstrating reproducibility and control of the process from small to large scale.


Although the bioprocess validation responsibility primarily falls on the primary drug manufacturer, suppliers can share the responsibility, supporting and supplementing primary manufacturers, with small scale process or membrane validation, using the drug product or drug substance. Collaborating with the primary drug manufacturer, a holistic validation control strategy (CS) can be better developed, leading to drug manufacturers better managing their product lifecycle management strategy.


Some points for consideration during a PLCM review include:


  • Review of prior and current process data, tech transfer data, validation data
  • Continuous monitoring of prior established and validated critical quality attributes (CQAs), prior established and validated critical control parameters (CPPs), and established specification and process control limits.
  • Pharmaceutical quality system (PQS) oversight from process feedback


For established or new processes, updates or process change controls implementing novel technology or equipment, can impact prior process validation data. Pall Biotech’s Acceleratorsm Validation Services can ease this process by conducting technical reviews with primary drug manufacturers, for validation or revalidation purposes, as necessary.




To find out more about bioprocess validation, view the white paper: A Risk Based Approach to Validation Studies for Sterilizing Filtration and Single-Use Systems


  • A Risk Based Approach to Validation Studies for Sterilizing Filtration and Single-Use Systems

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Wayne Lee – Senior Director of Global Validation Services and Laboratory Operations

Wayne Lee is a Senior Director of Global Validation Services and Laboratory Operations for Pall Biotech.
Wayne Lee is a Senior Director of Global Validation Services and Laboratory Operations for Pall Biotech.
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The Pall Biotech Approach


Pall Biotech offer Accelerator Validation Services to help customers overcome validation challenges. Aseptic filtration validation can be completed to ensure successful technology transfer when scaling up or out. We also assist customers with evaluation of hard-to-filter, challenging or high-risk fluids that require CPP validation, utilizing our Sterility Optimization by Assessment of Risk (SOAR) program.


The Accelerator Validation Services team can provide full aseptic filter membrane validation test work consultation and final validation reports for drug manufacturers, incorporating Quality by Design (QbD) principles. Some examples of our expertise include: Pre-use/Post sterilization integrity testing (PUPSIT), pre- or post-validation studies of sterilizing grade filtration or single-use (SU) validation, and subsequent tech transfer. We have also generated a library of E&L data from product contact materials (including identification of single use system components, polymers, chemical compounds, and toxicology studies), that we can help provide to drug manufacturers, that relate to their sterile filter or single-use manifold, if they intend to implement these unit operations in their process.


Staffed with highly skilled scientists and engineers, the team works to ensure that we are constantly aligned with current regulations from the FDA, EMEA, PIC/s, WHO, MHRA, TGA, and more. Our team also participates in various regulatory and best-practice associations like BPOG, PDA, ISPE, ASME, ASTM, and ISO to bring voice of the customer (VOC) into a holistic validation approach.


Optimizing Technology to Overcome Challenges 


Technology design and evolution plays a critical factor in delivering total solutions. Wherever possible we recommend that you automate the process and integrate process analytical technologies (PAT) to continuously monitor the CPPs of a process. This helps to support robust data integrity and evaluation during validation studies, which is information we can continue to build on.


High-resolution analytical instrumentation is applied to identify any leaching from polymeric product contact materials. We work to review E&L carry-over propensity studies and replicate them in small/micro-scale validation studies to overcome obstacles through scale-up and scale-out and into manufacturing phases.