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Rapid Response Production™ Facility

Rapid Response Production™ Facility
   Product Brief*
 

Rapid Response Production Facility Brochure


HyClone’s Rapid Response Production (RRP) service provides customers quick-turn production of cell culture media and reagents for research, product, and process development.

Development of industrial cell culture processes frequently require quick evaluation of customized or optimized media and buffers to facilitate final product selection and implementation. In research settings, minor modifications of existing media and reagent formulations may be necessary to accommodate specific goals and objectives.

Rapid Response Production is a media manufacturing service designed for the production of client-specific media and reagents with short turnaround times. Requests are typically manufactured within 7 days. The Rapid Response Production facility is capable of preparing up to 200 L liquid lot sizes and up to 10 kg dry powdered lot sizes. Liquid lots are packaged in 100, 500 and 1000 mL bottles, or in HyClone’s BPCs (100 L maximum). Dry powdered lots are packaged in volume-specific bottles or in bulk containers.

HyClone’s Rapid Response Production facility offers the highest quality products by following consistent and reproducible manufacturing practices. Documentation of Rapid Response Production lots is designed to provide component-specific tracking, and to facilitate technical transfer to HyClone’s cGMP manufacturing facility when requested.

Quality Control
Available quality control tests for RRP liquid lots:
• Sterility • Endotoxin
• pH • Osmolality

Available quality control tests for RRP dry powdered lots:
• Solubility • pH
• Moisture • Osmolality
• Particle Size  

Delivery Systems
HyClone offers a wide range of standard packaging sizes and delivery systems to meet your specific product requirements. Custom packaging is also available.

Format Delivery System Lot Sizes
Liquid 100 ml Bottles 10—20 L
Liquid 500 ml Bottles 10—100 L
Liquid 1000 ml Bottles 10—200 L
Liquid 5, 10, 20, 50, and 100 L BPCs 20—200 L

Format Packaging Lot Sizes
Dry Powdered Volume-Specific (L) 500 g—20 kg
Dry Powdered Bulk Powder 500 g—20 kg

Production Parameters
Rapid Response Production is operated in a facility with stringent access and operational restrictions. Personnel are trained in accordance with established manufacturing practices at HyClone. Additional features include:
     •  Liquid media lots are 0.2 micron sterile filtered (unless otherwise specified) in a certified laminar flow hood
     •  Rapid Response Production personnel follow established manufacturing procedures
     •  Single-contact, ADCF liquid media manufacturing is available upon request

Raw Materials
The components used in preparing RRP products are manufactured using the same components that are utilized in HyClone’s cGMP facility. These components have complete HyClone Quality Control acceptance and vendor lot traceability. Should your Rapid Response Production lot require components not presently qualified at HyClone, they will be sourced from one of HyClone’s many approved vendors.

Rapid Response Production Requests
To initiate Rapid Response Production services, download the attached product brief form, fill it out and fax to HyClone at 435-792-8001.

Capabilities Section Navigation
  Capabilities
> Rapid Response Production Facility
  HyNetics Single-Use Disposable Manufacturing
  Research and Product Development
  Metabolic Pathway Design
  Media Optimization
  Water for Injection System
  Continuous Micronization

 


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