Immunologic Deficiency Syndromes

<section class="Section" data-sectioncode="34089-3"><a name="ID_546163c5-5465-415f-a3c1-61a971d78cbd"></a><a name="section-9"></a><h1>11 DESCRIPTION</h1>XEMBIFY, immune globulin subcutaneous, human-klhw, is a 20% ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for subcutaneous administration. The purity is ≥ 98% IgG with a sub-class distribution similar to that found in normal serum.XEMBIFY consists of 18% to 22% protein in 0.16 M to 0.26 M glycine and 10 to 40 mcg/mL polysorbate 80 at a pH of 4.1 to 4.8.  The solution is clear to slightly opalescent, and colorless or pale yellow.  The osmolality range is 280 to 404 mOsmol/kg. XEMBIFY contains no preservative and is not made with natural rubber latex.XEMBIFY is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. XEMBIFY is incubated in the final container (at the low pH of 4.1 to 4.8).The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV-2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g. herpes viruses); West Nile Virus (WNV) as a relevant virus; Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.Overall virus clearance capacity was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key parameters.<table cellpadding="4" cellspacing="0" width="60%"><caption>Table 3: Summary of Virus Clearance Capacity (Log10)</caption><colgroup><col align="center"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/></colgroup><thead><tr class="First"><td align="center" class="Botrule Lrule Rrule" rowspan="2">Process Step</td><td align="center" class="Botrule Rrule" colspan="4">Enveloped Virus</td><td align="center" class="Botrule Rrule" colspan="3">Non-Enveloped Virus</td></tr><tr class="Last"><td align="center" class="Botrule Lrule Rrule">HIV-1</td><td align="center" class="Botrule Rrule">BVDV</td><td align="center" class="Botrule Rrule">PRV</td><td align="center" class="Botrule Rrule">WNV</td><td align="center" class="Botrule Rrule">Reo3</td><td align="center" class="Botrule Rrule">HAV</td><td align="center" class="Botrule Rrule">PPV</td></tr></thead><tfoot><tr><td align="left" colspan="8"><dl class="Footnote"><dt><a href="#footnote-reference-5" name="footnote-5">*</a></dt><dd>C/I: Interference by caprylate precluded determination of virus clearance capacity for this step</dd><dt><a href="#footnote-reference-6" name="footnote-6">†</a></dt><dd>DHBV and SINV were also evaluated for the caprylate incubation step. The log10 clearance capacities were ≥3.6 and ≥6.0, respectively.</dd><dt><a href="#footnote-reference-7" name="footnote-7">‡</a></dt><dd>NA = Not applicable: This step is not applicable to non-enveloped viruses.</dd><dt><a href="#footnote-reference-8" name="footnote-8">§</a></dt><dd>Due to interfering effects of the process intermediate matrix the virus clearance capacity could not be determined.</dd></dl></td></tr></tfoot><tbody><tr class="First"><td align="center" class="Botrule Lrule Rrule"> Caprylate Precipitation/Depth Filtration </td><td align="center" class="Botrule Rrule"> C/I<a class="Sup" href="#footnote-5" name="footnote-reference-5">*</a>.</td><td align="center" class="Botrule Rrule"> 2.7 </td><td align="center" class="Botrule Rrule"> C/I<a class="Sup" href="#footnote-5">*</a></td><td align="center" class="Botrule Rrule"> C/I<a class="Sup" href="#footnote-5">*</a></td><td align="center" class="Botrule Rrule"> ≥3.5 </td><td align="center" class="Botrule Rrule"> ≥3.6 </td><td align="center" class="Botrule Rrule"> 4.0 </td></tr><tr><td align="center" class="Botrule Lrule Rrule"> Caprylate Incubation<a class="Sup" href="#footnote-6" name="footnote-reference-6">†</a></td><td align="center" class="Botrule Rrule"> ≥4.5 </td><td align="center" class="Botrule Rrule"> ≥4.5 </td><td align="center" class="Botrule Rrule"> ≥4.6 </td><td align="center" class="Botrule Rrule"> ≥5.1 </td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7" name="footnote-reference-7">‡</a></td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7">‡</a></td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7">‡</a></td></tr><tr><td align="center" class="Botrule Lrule Rrule"> Column Chromatography </td><td align="center" class="Botrule Rrule"> ≥3.0 </td><td align="center" class="Botrule Rrule"> 4.0 </td><td align="center" class="Botrule Rrule"> ≥3.3 </td><td align="center" class="Botrule Rrule"> ND<a class="Sup" href="#footnote-8" name="footnote-reference-8">§</a></td><td align="center" class="Botrule Rrule"> ≥4.0 </td><td align="center" class="Botrule Rrule"> ≥1.4 </td><td align="center" class="Botrule Rrule"> 4.2 </td></tr><tr><td align="center" class="Botrule Lrule Rrule"> Nanofiltration </td><td align="center" class="Botrule Rrule"> ≥3.7 </td><td align="center" class="Botrule Rrule"> ≥4.1 </td><td align="center" class="Botrule Rrule"> ND<a class="Sup" href="#footnote-8">§</a></td><td align="center" class="Botrule Rrule"> ND<a class="Sup" href="#footnote-8">§</a></td><td align="center" class="Botrule Rrule"> ≥1.8 </td><td align="center" class="Botrule Rrule"> ND<a class="Sup" href="#footnote-8">§</a></td><td align="center" class="Botrule Rrule"> 0.5 </td></tr><tr><td align="center" class="Botrule Lrule Rrule"> Low pH Final Container Incubation </td><td align="center" class="Botrule Rrule"> ≥5.3 </td><td align="center" class="Botrule Rrule"> 4.9 </td><td align="center" class="Botrule Rrule"> ≥5.1 </td><td align="center" class="Botrule Rrule"> ≥5.3 </td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7">‡</a></td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7">‡</a></td><td align="center" class="Botrule Rrule"> NA<a class="Sup" href="#footnote-7">‡</a></td></tr><tr class="Last"><td align="center" class="Botrule Lrule Rrule">Overall Clearance Capacity</td><td align="center" class="Botrule Rrule">≥16.5</td><td align="center" class="Botrule Rrule">≥20.2</td><td align="center" class="Botrule Rrule">≥13.0</td><td align="center" class="Botrule Rrule">≥10.4</td><td align="center" class="Botrule Rrule">≥9.3</td><td align="center" class="Botrule Rrule">≥5.0</td><td align="center" class="Botrule Rrule">8.2</td></tr></tbody></table>Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD), and Creutzfeldt-Jakob disease (CJD) agents.Several of the individual production steps of the manufacturing process have been shown to decrease TSE infectivity of an experimental model agent. TSE reduction steps include depth filtrations (a total of ≥ 6.6 log10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</section>

XEMBIFY

immune globulin subcutaneous (human) - klhw

5 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection

Xembify

5 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]

10 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection

10 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]

20 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection

20 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]

50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection

50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]

immunoglobulin G

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

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