Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Analytical Testing to Support Biopharmaceutical Products

April 2, 2007

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

Quality: Design Space for Biotech Products

April 1, 2007

Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.

USP Seeks Participants for Glycan Analysis Study

March 22, 2007

The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.

CMC Strategy Forum Takes on Glycosylation

March 22, 2007

The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.

Downstream Processing: Platform Technology for Developing Purification Processes

March 1, 2007

To shorten time to market for new therapeutic proteins, new and fast methods, such as high throughput screening, are needed to speed up downstream processing. The platform technology discussed in this article includes a structural approach that can be used as a general procedure to purify therapeutic proteins. The approach starts with ligand screening and selection-on-a-chip, with the Surface Enhanced Laser Desorption Ionization–Time of Flight (SELDI–TOF) mass spectrometer system. Next, resin screening and supplier selection are performed using robotics, followed by scouting studies under dynamic conditions to select the best resin. Finally, optimization studies of critical parameters are carried out with statistical design approaches (design of experiments). A few examples are presented to explain the platform approach for purification development in more detail.

ALTERNATIVES TO PROTEIN A: Improved Downstream Process Design for Human Monoclonal Antibody Production

February 2, 2007

Affinity purification schemes for antibody production have certain limitations keeping up with cell culture expression levels as they reach and exceed 10 g/L. New downstream purification processes are based on low cost, long lasting, and high binding (40–100 mg/mL) cation exchange resins.

INTRODUCTION: Advances in Process Chromatography The past, present, and possible future of process-scale chromatography

February 2, 2007

These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.

CONTINUOUS PROCESSING: The Multicolumn Countercurrent Solvent Gradient Purification Process

February 2, 2007

This article presents the multicolumn countercurrent solvent gradient purification (MCSGP) process, which uses three chromatographic columns, and incorporates the principle of countercurrent operation and the possibility of using solvent gradients. A MCSGP prototype has been built using commercial chromatographic equipment. The application of this prototype for purifying a MAb from a clarified cell culture supernatant using only a commercial, preparative cation exchange resin shows that the MCSGP process can result in purities and yields comparable to those of purification using Protein A.

VALIDATION: Advances in the Validation of Chromatographic Processes

February 2, 2007

ABSTRACT

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