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

ADVERTISEMENT

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 Draft Guidance, 1999 August; Bethesda MD.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 Draft Guidance 2000 August; Bethesda MD, p. 14.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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Novartis and GSK Trade Assets
April 22, 2014
Lilly to Acquire Novartis Animal Health
April 22, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here