Animal-Free Statement

All stages of R&D Systems’ animal-free production include the following:

Dedicated Laboratories: Our Animal-Free products are manufactured in a dedicated, controlled access facility which is used exclusively for the production, purification, and bottling of Animal-Free proteins.

Standard Operating Procedures: Every stage of R&D Systems Animal-Free product manufacturing employs Standard Operating Procedures (SOPs). SOPs are fundamental to assure consistency from lot to lot and guarantee the highest quality of products.

Deviation Systems: Our quality assurance protocols involve deviation systems, which ensure that any non-conforming products (i.e., that those do not meet the requirements outlined below) are identified at the earliest opportunity. All deviations are reported, investigated, and recorded.

In addition, each stage of our established protein production methodology has been specifically modified for the manufacture of Animal-Free products:

1. Molecular Biology:
   1. DNA is transformed into competent bacterial cells which are generated using animal-free media 
2. Fermentation:
   1. Fermentation processes follow approved SOPs.
   2. Raw materials and labware are animal-free* (see below).
   3. All raw materials are traceable through batch records.
   4. All batches of bacteria are grown in animal-free media.
   5. Dedicated animal-free fermentors are employed.
   6. Equipment cleaning procedures have been validated.
3. Purification:
   1. Purification processes follow approved SOPs.
   2. Dedicated animal-free columns are used.
   3. Column cleaning procedures have been validated specifically for animal-free manufacturing.
   4. All labware which comes in contact with the product is animal-free* (see below).
   5. Bulk purified proteins are filtered using certified animal-free filters.
   6. Purified proteins are stored in animal-free containers in a dedicated cold storage room.
4. Bottling/Labeling:
   1. Line clearance procedures ensure all relevant areas are cleared of materials from the previous operation before filling commences.
   2. Lyophilization is conducted separate from animal-derived products.
5. Documentation:
   1. Certificate of Analysis is available upon request.
   2. Certificates of Origin are available upon request.

*Additional Information for Lab Supplies

We ensure that lab supplies containing animal-derived materials meet the requirements necessary to inactivate Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE). Any peripheral supplies employed must: a) meet international requirements for minimizing the transmission of animal spongiform encephalopathy, and b) be subjected to rigorous BSE/TSE inactivation procedures.

Requirements for Usage of Lab Supplies

At this time, some of the peripherals used in R&D Systems’ animal-free production processes may be made of plastics that contain or come in contact with animal-derived substances. These materials must meet one or more of the following criteria regarding the transmission of animal spongiform encephalopathy:

• EMEA 410/01 Rev 2 Oct 2003.
• Regulation (EC) 1774/2002, Annex VIII, Chapert IV, A, 3(a)(ii).
• FDA 9CFR 94.18.

Treatment of Lab Supplies to Inactivate BSE and TSE

Letters are on file from the relevant manufacturers stating that supplies from outside vendors have also undergone at least one of the following rigorous methods that are recognized for the inactivation of BSE and TSE:

• Sterilization: at 200° C.
• Heat Inactivation: material is subjected to temperatures of greater than or equal to 95° C for greater than or equal to 3 hours.
• Trans-esterification or hydrolysis: material is subjected to a temperature of greater than or equal to 200° C under appropriate corresponding pressure for greater than or equal to 20 minutes.
• Saponification: material is subjected to 12 N NaOH.
• Continuous process: material is subjected to temperatures of greater than or equal to 140° C under pressure (2 bars) for greater than or equal to 8 minutes or equivalent.

Operational Excellence

In our continuing efforts to provide our customers with the highest quality proteins produced under stringent conditions, we will continue to search for animal-free replacements for the above mentioned peripherals and substitute these whenever possible.