A Case Study of Developing Analytical Methods - A contract manufacturer used seven analytical methods while developing an early-phase protein therapeutic in six short months. - BioPharm International

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A Case Study of Developing Analytical Methods
A contract manufacturer used seven analytical methods while developing an early-phase protein therapeutic in six short months.


BioPharm International


2. FDA. CDER. Guidance for Industry, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Draft Guidance, 1999 August; Bethesda MD. p. 3.

3. Voet D, Voet J. Biochemistry. John Wiley and Sons, New York. 1990; page 81.

4. Schenerman M. Isoelectric Focusing. The Biopharm Guide to Bioanalytical Methods, Supplement to BioPharm International. 2001 December; p. 29.

5. Williams A, Frasca V. Ion Exchange Chromatography, In Current Protocols in Protein Science. John Wiley and Sons, New York, 1999; p. 8.2.1C.

6. Berger, Electrophoresis. The Biopharm Guide to Bioanalytical Methods, Supplement to BioPharm International. 2001 December; p. 20.

7. Williams A, Frasca V. Gel Filtration Chromatography, In Current Protocols in Protein Science. John Wiley and Sons, New York, 1999; p. 8.3.1.

8. FDA. CDER. Guidance for Industry, Analytical Procedures and Method Validation - Chemistry, Manufacturing, and Controls Documentation. Draft Guidance 2000 August; Bethesda MD, p. 14.

For addresses of the referenced suppliers of analytical materials and instruments, contact the authors.


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