Detergents for Use in Bioprocessing
Detergents, such as zwitterionic or non-ionic surfactants, are used in biomanufacturing processes for a variety of applications including viral inactivation and cell lysis.
Ensuring viral safety is essential for maintaining the safety profile of drug products for patients. Unlike methods such as chromatographic separation or virus filtration that physically remove viruses, viral inactivation techniques utilize chemicals or low pH conditions to effectively reduce the presence of infectious enveloped viruses. The specific approach to viral inactivation varies based on the process and the type of molecule involved.
However, the fundamental requirement remains consistent: the use of high-quality chemicals that are free from viral contaminants and suitable for biologics manufacturing.
What makes our detergents for biopharma Manufacturing unique?
- Commitment to Quality: Our products are manufactured according to stringent quality standards and backed by a global Quality Management System, supporting consistency and reliability in your bioprocess.
- Risk Mitigation: Comprehensive technical, regulatory and supply information as part of our Emprove® Program to accelerate your qualification, risk assessment, and process optimization efforts.
- Expert Support: Technical and regulatory support to help you overcome challenges and expedite your journey to market.
Looking for a Triton™ X-100 Alternative?
Triton™ X-100 (4-tert-octylphenol polyethoxylate), a non-ionic detergent, is commonly used for virus inactivation and cell lysis as it disrupts the lipid membrane of cells and enveloped viruses. Triton™ X-100 is the main detergent templated in biomanufacturing processes, but as of January 2021, its unauthorized use has been prohibited in the European Union by the European Commission, due to its listing to REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). In response to the global implications of restrictions on Triton™ X-100 detergent, we have developed the Deviron® portfolio of sustainable detergents.
The Deviron® Detergent Portfolio as a Sustainable Triton™ X-100 Alternative
Our Deviron® portfolio of detergents is a best-in-class alternative to Triton™ X-100 detergent used for biomanufacturing applications. We have developed our Deviron® detergents to address the need for alternatives to Triton™ X-100 that do not require a REACH authorization.
Key Benefits of Deviron® Detergents
- Biodegradability (REACH* Compliance) and lack of harmful degradation products
- Viral inactivation (5 Log Reduction Value)
- Cell lysis efficiency
- Minimal impact on product functionality or quality
- Lack of process interference
- Effective removal by downstream operations
- Availability of sensitive detection method
- Manufacturability of high volumes as IPEC-PQG GMP quality material
- Impurity profile compatible with parenteral usage
*Registration, Evaluation, Authorisation and Restriction of Chemicals
DEVIRON® C16 Emprove® Evolve
Provides detailed and transparent supply chain information and documentation to support risk assessments for critical raw materials used in manufacturing processes. Non-GMP but Manufactured utilizing GMP concepts and elements; ISO9001 or equivalent.
DEVIRON® 13-S9 Emprove® Expert
Addresses higher risk applications, where the lowest microbiological and endotoxin levels are of utmost importance. Released with IPEC-PQG GMP.
Related Resources
- Application Note: Solvent/Detergent Viral Inactivation of Plasma in Single-Use Containers
Read how using Deviron® C16 and 13-S9 detergents with Mobius® single-use containers for solvent-detergent virus inactivation reduces process contamination risk and increases efficiency compared to conventional stainless-steel systems.
- Product Guide: The Deviron® Detergent Portfolio
Find comprehensive information on the use of Deviron® detergents, our greener alternative to Triton™ X-100, for viral inactivation and cell lysis with extensive application data, detailed method descriptions, and guidance on detergent detection and removal.
- Flyer: Deviron® 13-S9 detergent, a greener alternative for Triton™ X-100
Discover what’s “green” about Deviron® 13-S9 and how it offers several sustainability benefits compared to Triton™ X-100, aligning with principles of Green Chemistry.
- Product Guide: Raw Materials for Biopharmaceutical Manufacturing
Explore our SAFC® portfolio of ready-to-use and customized material solutions, developed to meet the specific needs of pharma and biopharma production and backed by deep regulatory expertise.
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