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GLASSIA, is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.
The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.
Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.
There is currently no drug history available for this drug.
GLASSIA is a sterile, ready to use, liquid preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography.
GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods.
Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL.
To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV.
The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4.
Table 4: Log10 Virus Reduction during Manufacture of GLASSIA HIV-1: Human immunodeficiency virus Type 1, PRV; Pseudorabies virus, BVDV: Bovine viral diarrhea virus, WNV: West Nile virus, HAV: Hepatitis A virus, PPV; Porcine parvovirus
- ND - Not Done
- N/A - Not Applicable. The S/D treatment is not relevant for non-enveloped viruses.
Enveloped Viruses Non-enveloped Viruses Process Step HIV-1 PRV BVDV WNV HAV PPV Nanofiltration > 5.59 > 5.57 > 5.74 ND* > 4.99 4.04 S/D treatment > 6.41 > 6.14 > 5.61 > 6.32 N/A† N/A Global Reduction Factor > 12.00 > 11.71 > 11.35 > 6.32 > 4.99 4.04