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Related Concept Videos

Interpreting X̄ Charts01:13

Interpreting X̄ Charts

Interpreting x̄ charts, a type of control chart used in statistical process control helps monitor the variation in processes over time. The x̄ chart is based on the sample mean and allows for monitoring variations in the process mean over time. These charts are pivotal for quality assurance in manufacturing and other sectors.
An x̄ chart plots the values of individual measurements over time against control limits calculated from historical data. The central line represents the process mean,...
The X̄ Chart00:58

The X̄ Chart

The  x̄ chart is a statistical tool for monitoring the means in a process.
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A x̄ chart is constructed by plotting individual measurements of a quality characteristic in the order in which...
Steel Manufacturing01:26

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Steel manufacturing is a multi-stage process that begins by smelting iron ore into cast iron in a blast furnace. This initial stage involves layering iron ore with coke, a type of fuel, and crushed limestone within the furnace. The coke is ignited with a high volume of air, leading to the creation of carbon monoxide, which acts to reduce the iron ore to pure iron.
During this smelting process, limestone plays a crucial role by forming slag. Slag captures impurities within the molten iron, such...

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An improved manufacturing process for Xyntha/ReFacto AF.

B Kelley1, M Jankowski, J Booth

  • 1Process Development, Genentech, Inc, 1 DNA Way, South San Francisco, CA, USA.

Haemophilia : the Official Journal of the World Federation of Hemophilia
|January 1, 2010
PubMed
Summary
This summary is machine-generated.

The manufacturing process for ReFacto Antihemophilic Factor (AF) was improved to create Xyntha/ReFacto AF, a third-generation product free of animal- and human-derived materials. This enhanced process maintains the drug's efficacy and safety profile.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Hematology

Background:

  • ReFacto Antihemophilic Factor (AF) is a second-generation treatment for hemophilia A.
  • Its production process previously utilized human serum albumin (HSA).
  • A program was initiated to develop a third-generation product by removing all animal- and human-derived raw materials.

Purpose of the Study:

  • To detail the modifications made to the ReFacto AF manufacturing process.
  • To validate the removal of impurities and viral clearance in the new process.
  • To confirm that the changes do not impact the product's structural integrity, stability, or clinical efficacy.

Main Methods:

  • Removal of human serum albumin (HSA) from cell banks and culture medium.
  • Replacement of hybridoma-derived monoclonal antibody with a chemically synthesized affinity peptide.
  • Introduction of a virus-retaining filtration step for enhanced viral clearance.
  • Validation of purification process for model virus removal and host cell impurity clearance.

Main Results:

  • The improved manufacturing process successfully eliminated HSA and animal-derived components.
  • The purification process demonstrated significant clearance of tested viruses, including retroviruses.
  • Validations confirmed effective removal of host cell DNA, host cell protein, and the affinity peptide.
  • No detectable impact on the structural integrity, stability, or clinical efficacy of the antihemophilia A product was observed.

Conclusions:

  • The transition to Xyntha/ReFacto AF represents a significant advancement in hemophilia A treatment manufacturing.
  • The third-generation product offers an improved safety profile by eliminating human- and animal-derived materials.
  • The enhanced manufacturing process ensures the continued efficacy and stability of the antihemophilia A therapy.