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ATMPs are complex to manufacture
Contamination remains a critical concern in ATMP manufacturing, calling for advanced technologies to maintain sterility during aseptic filling. Learn about the needs of advanced therapies and one such technology tackling their challenges with this white paper.
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Ready to go gloveless?
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The ELEVECTA™ cell line portfolio combines innovative design and deep expertise to deliver transient, packaging, and producer options that provide competitive performance, high quality, and flexibility.
- Fit for purpose: Choose the option that makes sense for your stage, asset mix, and organizational goals.
- Flexible: Enjoy competitive terms and the freedom to transition between cell lines as needs evolve.
- Enhanced product quality*: Minimize host cell DNA inside capsids, which is resistant to nucleases.
- Innovative: Access advances in cell line engineering informed by deep industry know-how.
- Collaborative: We’re more than a supplier. Benefit from a comprehensive suite of regulatory support services designed to expedite your success in advancing to and through clinical trials.
SUPRAdisc™ II depth filter modules
Next generation in depth filter module technology for bioprocess clarification applications.
The SUPRAdisc™ II module design combines the filtration performance of Seitz™ media and the structural robustness of interlocking dual drainage plates.
13 Points to consider when selecting your next filter integrity test instrument
Choosing the right filter integrity test instrument, tailored to your needs, can be a difficult task. An informed decision will help ensure seamless integration of the instrument into your critical processes.
Process needs for filter integrity test instruments have changed over the years as regulations, technologies and best practice have evolved to improve patient safety. Our updated selection guide outlines important criteria to help you compare and evaluate your options when choosing a filter integrity test instrument.
Download the guide to learn more about:
- Regulations applicable to filter integrity test instruments including:
- Data integrity and data access control
- Good automated manufacturing practice (GAMP)
- EU and FDA Good manufacturing practice (GMP)
- How to choose the filter tests and features which are critical for your process, including forward flow (diffusive), water intrusion and bubble point testing
- A set of 13 criteria which can be used to compare and evaluate different instruments, including our Palltronic® Flowstar V filter integrity test instrument
Additional resources carousel
Description
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Article: Overcome challenges to carry out successful filter integrity testing
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