Articles by Anurag S. Rathore, PhD - BioPharm International



Articles by Anurag S. Rathore, PhD

Filter Clogging Issues in Sterile Filtration

Apr 1, 2008

A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.

Applications of MVDA in Biotech Processing

Oct 1, 2007

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

Lifetime Studies for Membrane Reuse: Principles and Case Studies

Sep 1, 2007

Quality: Design Space for Biotech Products

Apr 1, 2007

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

Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density Fermentation

For the biotech industry to be profitable, it must consider economics along with process recovery, purity, and product quality.
Nov 1, 2006

The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.

Applying Process Analytical Technology to Biotech Unit Operations

Aug 1, 2006

Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.

Efficiency Measurements for Chromatography Columns

Using the method of moments provides a better characterization of column effluent curves than the frequently used Gaussian approximation.
Aug 1, 2005

Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.

Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration

Constraints associated with equipment can make scale-down a challenging exercise.
Apr 1, 2005

Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.

Scaling Down of Biopharmaceutical Unit Operations — Part 1: Fermentation

The fermentation process can be challenging to scale down and several factors must be evaluated for each step.
Mar 1, 2005

Lot-to-lot variations between raw materials can greatly impact process performance.



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