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 Draft Guidance, 1999 August; Bethesda MD.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 Draft Guidance 2000 August; Bethesda MD, p. 14.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

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here