1. Flebogamma® 5% Human Normal Immunoglobulin for Intravenous Administration
Pure Confidence

2. Flebogamma® 5%: Plasma Safety
Grifols monitors the entire plasma production process from start to finish. All Grifols products are subjected to rigorous donor screening, testing and viral elimination (inactivation and removal) processes to enhance their quality and safety.
Grifols has been awarded the Quality Standards of Excellence Assurance and Leadership (QSEAL) by the Plasma Protein Therapeutics Association (PPTA).

3. Flebogamma® 5%: Processing plasma
More than 10 years of experience and know-how 4 5 8 10 15 1 2 3 6 7 9 11 12 13 14 16 17 18 19 20 21
1 - Frozen Plasma
2 – Thawing & Centrifugation
3 - Cryoprecipitate
4 – Cryoprecipitate-Poor Plasma
5 - Cold Ethanol Fractionation
6 - Centrifugation & Filtration
7 - Fraction II + III Precipitate
8 - Supernatant
9 - Centrifugation & Filtration
10 -Precipitate
11 - Stabilization with D-Sorbitol
12 - Pasteurization (60oC, 10 hours)*
13 - PEG Precipitation*
14 - Centrifugation & Filtration
15 - Supernatant
16 – DEAE - Sephadex Chromatography
17 - Concentration and pH Adjustment
18 - Centrifugation & Filtration
19 - Sterile Filtrations
20 - QC Testing Quarantine
21 - Flebogamma® 5%
*Viral elimination methods

4. Flebogamma® 5%: Viral Safety
Flebogamma® 5% was one of the first liquid immune globulins products to incorporate pasteurization as a viral inactivation method.
Pasteurization has been validated to achieve significant inactivation of both enveloped and non-enveloped viruses. Grifols developed a method of pasteurization (heat treatment at 60ºC 10 h) using sorbitol as a stabilizer, which avoids denaturalization of proteins and preserves antibody activity.

5. Flebogamma® 5%: Pure Confidence
High Purity
Ig purity: 99.37% ± 0.26
(n= 220 consecutive lots)

6. Flebogamma® 5%: Pure Confidence
High Purity
Monomers + Dimers content: > 99.9%
(n= 220 consecutive lots)

7. Flebogamma® 5%: Pure Confidence
High Purity
Fragments: Not detectable
(n= 220 consecutive lots)

8. Flebogamma® 5%: Pure Confidence
High Tolerability
IgA content: ± mg/ml
(n= 220 consecutive lots)

9. Flebogamma® 5%: Pure Confidence
High Tolerability
Anticomplementary Activity: 0.27 ± 0.06 CH50/mgIg
(n= 220 consecutive lots)

10. Flebogamma® 5%: Pure Confidence
High Tolerability
Pre-kallikrein Activator: <2 I.U.
(n= 220 consecutive lots)

11. Flebogamma® 5%: Pure Confidence
Physiologic
Isotonic solution: ± 0.26 mOsm/Kg
(n= 220 consecutive lots)

12. Flebogamma® 5%: Pure Confidence
Physiologic
Normal pH: 5.60 ± 0.07
(n= 220 consecutive lots)