CSL Behring's Commitment to Safety

We’re dedicated to providing a consistent and reliable supply of HSA
  • CSL commitments to delivering the volume of HSA that you need for your project
  • Specific resources that are experts in the utilization of excipient HSA
  • All of our plasma, for excipient purposes, is drawn in select FDA- and GHA-approved centers
  • CSL’s manufacturing process enhances batch-to-batch consistency
Overview of HSA Manufacturing
CSL Behring performs tri-testing to meet the needs of a globalizing marketplace

ACSL Behring performs tri-testing for excipient HSA lots in order to confirm their compliance with the regulations of US, European Union, and Japanese markets. Tri-testing includes all tests that are required by the FDA, EMEA, and PMDA. Because tri-testing helps meet the specific pharmacopeia requirements of the governing bodies, manufacturers will benefit from streamlined product sales in these areas.

For excipient HSA, Certificates of Analysis for each of these 3 regions can be provided, each one stating the performed tests with their requirements and results.

CSL Behring Albumin Licenses Worldwide

CSL Behring’s HSA excipient product, regulatory and quality practices are second to none

Clearing regulatory hurdles can be a great challenge both in terms of time and financial investment. To save you time and money, CSL Behring’s experts can provide assistance to facilitate registration of pharmaceutical or biological products and medical devices that contain HSA:

  • 25% HSA specification designated for global RA Bodies acceptation
  • Dedicated and highly experienced regulatory and quality teams support excipient HSA customers through all stages of clinical development and product registration worldwide
  • Our HSA is registered in numerous countries around the world; letters of access can be provided to health authorities on behalf of our customers
  • Additional up-to-date technical documentation can be provided to local health authorities to meet regulatory requirements
  • Batches are manufactured at CSL’s state-of-the-art fractionation facilities in Bern, Switzerland, and meets USP, EU and JP specifications
  • Each plasma pool and final product batch is sent to an Official Medicines Control Laboratory (OMCL) for testing and release; OMCL certification can be provided for each batch that is delivered
  • Vendor questionnaires can be completed and site audits may be scheduled, as per contractual agreement
  • Additional documentation can be provided as needed
  • Exclusively manufactured from 5 Virus Marker tested U.S. Source Plasma, drawn in select FDA-and EUapproved centers belonging to CSL Behring
  • Triple testing/comprehensive batch documentation: USP/EU/JP CoA’s, Swissmedic batch release certificate (OCABR), Summary Production and Control Protocols, Testing Declaration, etc.
  • Letter of Authorization (LOA) to existing HSA licenses or alternatively submission of abbreviated excipient HSA dossier
  • PMF full access for EU markets and reference to Swiss/EU PMF approval for Emerging Markets