Quality by design: Impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody

Author:

Awotwe-Otoo David,Agarabi Cyrus,Wu Geoffrey K.,Casey Elizabeth,Read Erik,Lute Scott,Brorson Kurt A.,Khan Mansoor A.,Shah Rakhi B.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference32 articles.

1. Thermally induced denaturation of lyophilized bovine somatotropin and lysozyme as impacted by moisture and excipients;Bell;J. Pharm. Sci.,1995

2. Lyophilization strategies for development of a high-concentration monoclonal antibody formulation: benefits and pitfalls;Bhambhani;Am. Pharm. Rev.,2010

3. Effect of moisture on the stability of a lyophilized monoclonal antibody formulation;Breen;Pharm. Res.,2001

4. Defining your product profile and maintaining control over it. Part 4: product-related impurities: tackling aggregates;Brorson;BioProcess Int.,2005

5. Development of an efficient single-step freeze-drying cycle for protein formulations;Chang;Pharm. Res.,1995

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