At Talecris Biotherapeutics, we strive to provide excipient customers with the most up-to-date information required for your business. For your convenience, the professionals at Talecris Biotherapeutics have compiled the most common questions received based upon areas of need.

Please feel free to contact Talecris Biotherapeutics' Business Development Department for any additional information.

Click on any question below.

1. What is your address and phone number? 2. Does Talecris Biotherapeutics Albumin product meet USP, EP or Japanese specifications? 3. How do Talecris Biotherapeutics Albumin products assure safety from virus and prion pathogens? 4. Does Talecris Biotherapeutics provide Plasma Protein Fraction (Human) 5% USP, also known as Plasmanate®, to support Stem Cell growth? 5. I will need a Certificate of Analysis for every lot of albumin that we use. Will Talecris Biotherapeutics be able to provide this? 6. I will need Talecris Biotherapeutics Albumin registration documentation to support and maintain worldwide registrations. Will Talecris Biotherapeutics be able to support our documentation needs? 7. My company will require a vendor audit. Is Talecris Biotherapeutics willing to support this request? 8. Is Talecris Biotherapeutics an experienced excipient supplier? 9. Where is Talecris Biotherapeutics Albumin product produced?

Talecris Biotherapeutics
79 TW Alexander Drive
4101 Research Commons
Research Triangle Park, NC 27709
Phone Number: (919) 316-6312

A2. Talecris Biotherapeutics Albumin Products have registrations in over 40 countries. Talecris Biotherapeutics provides Human Serum Albumin, meeting United States Pharmacopeia (USP), European Pharmacopeia (EP), and/or Japanese specifications.

A3. Talecris Biotherapeutics provides validated steps to ensure pathogen safety.

Talecris Biotherapeutics Albumin products have validated and robust virus clearance steps for both enveloped and non-enveloped viruses. There are four different virus reduction steps: two removal steps and two virus-kill steps, including Talecris Biotherapeutics's unique acetone suspension and pasteurization, thus exceeding the highest regulatory requirements for effective clearance of enveloped and non-enveloped viruses.

A Talecris Biotherapeutics patented Western blot assay has also confirmed removal of prion protein during spiked manufacturing simulations.

Talecris Biotherapeutics received a Notice of Allowance from the United States Patent Office for a patent covering the use of the Western Blot Assay to confirm removal of pathogenic prion proteins during the manufacture of therapeutic proteins. This test is the first of its kind in the biological products industry.

The patent covers a process Talecris Biotherapeutics uses for a quicker and less expensive assessment of prion protein removal during the manufacture of human plasma-derived products. The pathogenic form of prion proteins has been associated with fatal diseases, including Creutzfeldt-Jakob Disease (CJD). To date, no clinical evidence suggests the transmission of human transmissible spongiform encephalopathies (TSEs), such as CJD, by blood or blood plasma-derived products, but Talecris Biotherapeutics scientists are working toward eliminating this theoretical risk for transmission.

Talecris Biotherapeutics' Human Serum Albumin is free of bovine sources and therefore reduces this growing regulatory concern regarding TSE.

A4. Talecris Biotherapeutics does provide Plasma Protein Fraction (Human) 5% USP, Plasmanate^®.

Plasmante^® has been prepared from large pools of human plasma. Each 100 ml of Plasma Protein Fraction (Human) 5% USP contains 5 g selected plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L.

Many customers have experienced positive results with Plasmanate^® in their work with stem cells.

A5. Yes, if requested Talecris Biotherapeutics can provide a Certificate of Analysis for every lot. Notify Talecris Biotherapeutics that you will need this, and include the request on your Purchase Order to ensure it is included with your order.

A6. Talecris Biotherapeutics has experienced regulatory and quality assurance personnel to help identify your specific documentation needs, and how best to supply the materials your specific situation will require. Talecris Biotherapeutics also has strong working relationships with respective regulatory agencies, and prides themselves on being responsive to unique customer requirements.

A7. Talecris Biotherapeutics is responsive to unique customer requirements, such as customer site audit requests.

A8. Talecris Biotherapeutics has sold more than 150 million grams of albumin worldwide from 1998-2002, including supplying use as excipient and cell culture component for their worldwide rFVIII product line.

Other Talecris Biotherapeutics Albumin customers use Talecris Biotherapeutics' albumin products as a protein stabilizer, in stem cell research, or as a nutrient to promote cell growth. It is also used in Lipumin, a cell growth media designed to replace bovine calf serum.

A9. Global supplies of Talecris Biotherapeutics Albumin products are produced at Talecris Biotherapeutics' US manufacturing site, located in Clayton, NC, that is inspected by FDA, Canadian Health Authorities, German Health Authorities and by organizations from around the world including Japan.