Optimized Downstream Conditions
Our Wide Range of Standard and Custom Made Process Buffers Will Optimize Your DSP Steps for Monoclonal Antibodies, Recombinant Proteins, Vaccines and Antibody Drug Conjugates
Global manufacturing facilities follow cGMP (21CFR820), ISO (9001) and ISO (13485) regulatory protocols to ensure a consistent, reliable and uninterrupted supply of your powder and liquid buffers in your preferred packaging. Whether you need a standard off-the-shelf buffer or a customized solution, Sartorius has an experienced team to guide your selection and development. Our offering also covers a wide range of applications including cleaning, transport and fill & finish.
Integrated Approach of Buffer Preparation
Downstream Processing Buffers
Buffer Solutions For Purification Steps
Either you are looking for a standard formulation including Sterile-Filtered WFI (water for injection-quality water) or a fully custom downstream product; we can manufacture any formulation to meet your specific needs when it comes to downstream processing steps.
Downstream Processing NaOH
Off-the-Shelf NaOH 1M for further manufacturing use
- Highest quality: NaOH 1M is manufactured with EP | USP grade NaOH and WFIquality water
- Proven chemical compatibility with Flexsafe® film
- Easy to implement: relevant documentation for dangerous goods available and ADRvalidated shipping box
- NaOH 1M is typically used for chromatography steps, pH adjustment for media & buffer prep, cleaning of stainless steel equipment....
Aseptically Processed WFI Quality Water
Water For Injection Quality Water For Laboratory & Manufacturing Use
Our Sterile-Filtered Water For Injection (WFI) Quality Water products are manufactured and tested according to strict industry standards. It meets or exceeds USP and EP requirements. Use for in vitro diagnostic procedures has not been established, this product is manufactured aseptically under cGMP 21CFR820 conditions by a validated sterile filtration method. Our Sterile-Filtered Water For Injection (WFI) Quality Water can be used for media & buffer preparation, hydration, cleaning, washing, rinsing of filters or Equipment.
Buffer Quality Systems
Priority On Quality, Flexibility And Assurance Of Supply
The process begins with approved and specified raw materials obtained from qualified vendors. Our insistence on superior-quality materials includes complete NAO (non-animal origin) traceability. Our buffer and Water for Injection (WFI) production systems meet both US and European Pharmacopoeia standards. Standard testing on finished products includes tests for sterility, osmolality, pH, and endotoxin content.
Broad Capacities For Buffers & WFI-Quality Water
All Process Buffers You Need For Your Downstream Purification Steps
Buffer needs and volumes can become very large as processes grow and Sartorius is well equipped to work with you on minimizing the burden associated with transport logistics. We offer an extensive array of downstream processing buffers for protein, cellular, and viral-based therapeutics. Appropriate for the techniques you perform and for each steps of your process.