As a global leader in the plasma protein biotherapeutics industry, CSL Behring is passionate about safety and quality.
Excipient HSA
(HSA) is a natural protein found in the human body. It has proven preferable to artificial mediums, ideal as a stabilizer in pharmaceutical and biotech products, effective as a drug delivery vehicle, and very useful in cryo preservation and cell culture, as well as in other applications.
Customers choose CSL Behring HSA for several reasons.
Select batches, specifically manufactured: Only U.S. Normal Source Plasma, drawn in select FDA- and GHA-approved centers, is used to manufacture excipient albumin. Each batch is manufactured in the same state-of-the-art fractionation facility, and meets both USP and EP specifications. Lot release protocols or Certificates of Analysis are available. Each batch is sent to an OMCL laboratory for testing and release; certification can be provided.
Plasma safety: CSL Plasma maintains a Quality Management System in accordance with the ISO9001:2000 Standard, including a mature, comprehensive internal audit process. In addition, the CSL Plasma fleet of collection centers is routinely audited by U.S. and international regulatory agencies. The centers are IQPP certified by the
Plasma Protein Therapeutics Association
.
Site audits can be scheduled as needed.
Each plasma unit used to manufacture excipient albumin is tested by required serological methods, and minipools are tested for five different viruses using NAT amplification methods.
Safety in excipient manufacturing: Viral removal and inactivation steps during manufacture ensure safe use. CSL Behring fractionation facilities are QSEAL certified by the Plasma Protein Therapeutics Association.
Regulatory support: The CSL Behring plasma master file (PMF) is submitted and certified annually by the European Community EMEA; certification can be provided.
When necessary, excipient customers have access to worldwide registrations of CSL Behring HSA. Clearing regulatory hurdles can be a great challenge both in terms of time and financial investment. CSL Behring provides assistance to facilitate registration of pharmaceutical or biological products, or medical devices, containing HSA. A customized Excipient Dossier can be provided to local health authorities to meet regulatory requirements, and site audits can be scheduled as needed.
Excipient product availability: The product is available in the following sizes and strengths:
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