Buffer Management Manufacturing Solutions For Biopharma Workflows

That’s why Avantor^® offers a wide range of buffer management solutions to help you save time and reduce expenses. We can help you resolve your buffer management challenges to help reduce your manufacturing footprint, save time, and reduce manufacturing expenses.

There are several ways to supply buffers and process liquids. One way is to manufacture buffers in-house with purified water that meets USP standards or water for injection (WFI) standards to hydrate powders in stainless steel or single-use tanks.

This method may be ideal for a large volume of stock solutions; these are resource-intensive activities that need significant infrastructure. That includes warehouse space for storing raw materials and a weighing and dispensing area.

Considering the complexity and cost of buffer preparation, using hydrated, premade liquid buffers and buffer concentrates can save time and resources and reduce overall buffer management costs.

OPTIMIZE YOUR BUFFER PREPARATION PROCESSES

Depending on the size of your biopharma manufacturing operations—whether you operate a large-scale biomanufacturing facility or a smaller operation—different approaches to resolve buffer management can be applied as stand-alone solutions or combined with other strategies to achieve workflow improvements. Among those approaches are:

• Ready-to-use cGMP buffer solutions
• Buffer concentrates, used with line dilution
• Buffer stock concentrates used in with buffer stock blending

By understanding and evaluating alternative buffer management strategies and the resources you’ll need to execute them, you can help ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.

Reduce total cost of buffer prep and management by leveraging Avantor‘s media and buffer preparation capabilities

Leveraging Avantor’s manufacturing capabilities as well as our quality, supply chain and logistics expertise, you can concentrate on your core product development and manufacturing work. Depending on which buffer management strategy you choose, benefits from outsourcing your buffer preparation include:

Time and cost savings

• Reduction of production process steps
• Reduced time for powder dissolution incl. declumping
• Reduced batch-time
• Labor savings/Personnel can be assigned to other tasks
• Saving of storage in buffer bags or holding tanks
• Reduce facility footprint of the buffer management system
• Lower capital investment

Secured quality

• Tested to extensive analytical specifications
• Reduced non-conformities
• Satellite samples for reduced QC testing
• Quality support for rapid release and investigation
• Reduced regulatory risk
• Enhanced operator safety (e.g. reduced chemicals exposure, no spill cleanup)
• Decreased safety and ergonomic concerns during processing

Supply chain security

• Streamlined supply processes
• Remote access to raw material and finished good data
• Robust database to track chemical inventory

Avantor quality systems and standards

• cGMP/ICH Q7, IPEC, ISO 9001 and ISO 13485
• Full GMP process, cleaning, analytical validation
• Testing: Compendial, analytical method development and validation for customer specification
• Shell Life Determination: Formal stability studies
• Avantor Management of Change program (MOC)
• Animal Origin Free facilities
• Preparation in ISO classed suites as appropriate

Avantor can work with you to find the most appropriate solution to clear bottlenecks across your development and manufacturing processes.

Avantor enables rapid supply of biopharma reagents and buffered solutions, outsourcing of your single- and multi-component buffer preparation. Utilizing Avantors’ in-house production of J.T. Baker™ chemicals, custom single-use assemblies, external sourcing of components that are optimized for your process and warehousing capabilities allows you to free up valuable space in your facility while realizing cost, time and labor savings, and to focus on your core activities.