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
Ready-to-Hydrate Powder Buffers
Optimal convenience for consistent buffer preparation by opting for buckets; pre-filled powder transfer bags; or Flexel® Liners. Dedicated solutions covering either closed or open mixing. Get started with our off-the-shelf powders or request a customized formulation.
Ready-to-Use Liquid Buffers
Buffers are manufactured according to precisely defined specifications, including:
- Sterile-grade filtration using Sartopore® 2 PES-membrane filters
- Liquid production follows cGMP | ISO13485 referential
Gain in time and scalability. Liquids are packaged in single-use Flexsafe®️ bags, ranging from 250mL to 1,000L in ASTM validated shipping containers.
Strong Acids, Bases, Alcohols & Detergents
Downstream Processing NaOH
Off-the-Shelf NaOH 1M for further manufacturing use
- Highest quality: NaOH 1M is manufactured with EP | USP grade NaOH and WFI-quality water
- Proven chemical compatibility with Flexsafe® film
- Easy to implement: relevant documentation for dangerous goods available and ADR-validated shipping box
- NaOH 1M is typically used for chromatography steps, pH adjustment for media & buffer prep, cleaning of stainless-steel equipment
WFI - Quality Water
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.
A Broad Range of High Quality Formulations
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.
Customized Solutions for Unique Needs
Production-Focused Approach to Produce Your Unique buffer and water for injection Solutions
Perfect choice for clients who have known, desired media composition and outcome expectations. For critical raw materials you can either request specific suppliers or rely upon Sartorius' established global network of qualified suppliers. Customized packaging, buffers and WFI formats, and release assays are also available upon request.