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KBI Biopharma Inc. sell "cGMP Protein and Antibody Purification"

Basic Information

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Trade Type

Sell

Service Name

cGMP Protein and Antibody Purification

Service Provider(s)

Specifications

  • Purity: cGMP-compliant purification processes achieving high product purity for monoclonal/bispecific antibodies, enzymes, Fc fusion and PEGylated proteins
  • Impurity Profile: Processes designed to reduce host cell protein, DNA and aggregate impurities to meet regulatory specifications
  • Elemental Impurities: Purification processes controlled to meet elemental impurity limits consistent with biologics manufacturing standards

Other Information

Additional Description:

KBI Biopharma has deep experience developing purification processes for a wide range of biotherapeutics, including monoclonal antibodies, bispecific antibodies, enzymes, Fc fusion proteins, PEGylated proteins, and complex glycoproteins. It supports more than 40 programs a year, spanning first-in-human process development through late-stage development, characterization, and validation, backing over 15 IND submissions annually; drawing on process development experience across more than 75 biomolecules, KBI has refined standard approaches for various protein classes, including monoclonal antibodies, and built a toolbox for resolving distinctive purification challenges.
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