Development of a Modified Purification Process for a Monoclonal Antibody Therapeutic-Yield Improvement
Benefits of the Case:
Improved yield of Mab product from bulk harvest by 1.8 fold
Simplified downstream purification process by eliminating the collection of fractions and the need for stat assays during manufacturing operations
Eliminated the use of resins that were difficult to pack and resulted in declining yields with short life cycles
Background of Challenge:
The Mab product had been manufactured at the 2,000L scale.
Production at the 10,000L cGMP manufacturing scale was planned.
The Mab product harvest contained several product variants.
Mab product variants had very similar biophysical properties to Mab of interest.
Yield of Mab was unacceptably low.
Collection of column fractions was required to obtain desired Mab purity.
Host cell modifications were not acceptable.
Evaluate alternative chromatography resins for efficient removal of the product variants.
Eliminate collection of fractions by using step gradients.
Optimize process to increase product through put and reduce process costs.
The purification process was modified by developing an intermediate and final high resolution polishing step.
Purity specifications the Mab product were maintained.
Yield of Mab was increased 1.8 fold.
Value for the Client
The yield for a Mab antibody therapeutic was significantly improved.
The purity specifications for the Mab product were maintained.
The need for collection and stat analysis of chromatography fractions was eliminated.
A significant manufacturing issue was eliminated.