Streamlining Compliance, Saving Time and Resources
Let Access Services years of filtration and process optimization experience save you time and resources. We offer high quality standard service packages and customized solutions -- developing validation protocols and test methods to meet the stringent requirements of global regulatory agencies.
With an established global network of Validation Sciences Laboratories we are ready to work with you to determine the appropriate testing methods for your specific process needs -- helping you navigate the maze of regulatory complexities so that you can concentrate on your business, while we concentrate on the details.
- Early Phase Filter Qualification Package
Minimize risks and ensure the quality of investigational medicinal products in agreement with current guidelines.We can provide another level of process understanding and qualification of your sterile filtration process that can ultimately result in time and cost savings upon scale-up.
- Retention Testing
Bacterial retention testing and Mycoplasma retention testing for process fluids are critical steps in filter validation. Our validation experts conduct testing on a lab-scale at our state-of the-art laboratories, using scaled-down processing conditions to determine the correct retention test parameters for your specific requirements.
- Bacteriophage Retention Capacity Analysis
Removing viruses from mammalian recombinant proteins, tissue extracts, monoclonal antibodies or blood derivatives—and validating the process—are key elements in downstream biopharmaceuticals production. We help ensure the success of your virus filtration unit operation and validation with scaled down, custom designed Bacteriophage Retention Testing.
- Chemical Compatibility
We offer Chemical Compatibility testing for a wide range of products that come in contact with your drug products. Our validation experts help you assess the risk of your application, and recommend the appropriate level of testing to mitigate this risk.
- Extractables and Leachables Analyses
Save time and expense for method development and validation, receive comprehensive data supporting regulatory compliance. Our expertise in analytical chemistry and in-depth knowledge of our materials and manufacturing processes allows us to develop and validate the most effective analytical methods for extractables and leachables analyses of our products.
- Technical Brief: Extractables and Leachables Approach
This Technical Brief provides an overview on how to approach extractables and leachables evaluation for filters, bags and other components used in biopharmaceutical manufacturing processes including Single-Use applications. It aims at assisting our world-wide customers in fulfilling their responsibilities with respect to extractable and leachable substances evaluation.
- Ingredient Adsorption Studies
Access Services experienced validation professionals help you address the potential impact that ingredient adsorption could have on the efficacy, safety, and overall quality of your filtered drug product.
- Product-based Integrity Testing
Accurate testing of filter integrity is vital for safe, efficient pharmaceutical production, and complying with regulatory requirements. Access Services Product-based Integrity Testing provides you with the highest level of confidence to ensure your products’ sterility and regulatory compliance.
- Early Phase Clinical Trial Testing Package
The production of investigational medicinal products presents additional challenges compared to marketed products. Product sterility is critical. Our applications experts help evaluate your manufacturing setting, and identify potential hazards early in your development process that could impact product sterility.
Our experienced applications professionals help streamline your implementation and validation of critical instruments, equipment and systems with on-site support for Installation Qualification (IQ) and Operational Qualification (OQ) test methods, and Performance Qualification (PQ) -- written to the same standards as protocols used to validate pharmaceutical processes. Data analysis, report generation, and operator technical training are all part of our comprehensive services.
The biopharmaceutical industry is subject to tighter regulatory standards than ever before. Guidelines are more stringent, and validation requirements are more complicated.
Access Services has developed a broad range of regulatory and compliance services designed to meet the strict requirements of worldwide regulatory agencies. Our regulatory experts help you navigate the complexities of regulatory compliance – saving you valuable time and resources while reducing your risk.
- Sterilizing Grade Filter Revalidation
The implementation of process changes can often impact the validated state of a process. This compliance risk is managed by well executed change control programs. This application note is provided as a tool to assist you in assessing the impact of process changes on your sterilizing grade filter validation. Additionally, you can contact your local Access Services Laboratory to request a revalidation assessment conducted by their team of experts.
