Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody

Author:

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

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference32 articles.

1. Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody;Awotwe-Otoo;Int. J. Pharm.,2012

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. A practical method for resolving the nucleation problem in lyophilization;Bursac;BioProcess Int.,2009

5. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants;Chang;J. Pharm. Sci.,1996

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