BioPharm International’s Biopharma Knowledge Resources Newsletter:
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BioPharm
December 20, 2018
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In This Issue

Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers.

 Featured App Note

Fast Track Formulation pH Screening with Automated Buffer Exchange on Big Tuna

Unchained Labs

The critical process of screening formulation buffers to optimize stability is labor intensive and time consuming, which are often limiting factors in biologics development. The conformational, chemical, and colloidal stability of a protein are strongly influenced by the buffer solution

Quality

SERS for Rapid Detection of the Low-Dose API in Xanax

Kristen Frano, Dawn Yang, B&W Tek

This paper demonstrates how a surface-enhanced Raman spectroscopy (SERS)-based approach can be used to quickly verify the presence of low-dose APIs in tablets for anti-counterfeiting in the pharmaceutical industry.

Downstream Processing

Antibody Affinity Extraction for HCP Analysis

Ken Hoffman, Eric Bishop, Cygnus Technologies, LLC

Antibody affinity extraction (AAE) is a superior alternative to 2D Western blot for demonstrating host cell protein (HCP) antibody coverage and reactivity to those HCPs that persist through the downstream purification process.

Antibody Drug Conjugate Purification Using TOYOPEARL® PPG-600M Resin

Tosoh Bioscience LLC

In this application note, antibody drug conjugates (ADCs) were separated into groups with low, medium, and high drug-to-antibody ratios (DARs) using TOYOPEARL PPG-600M resin with a three-step gradient.

Purifying Humira Biosimilar with Mixed-Mode Resins

Randy Drevland, Chelsea Pratt, Payal Khandelwal, Laura Moriarty, Elizabeth Jordan Dreskin, Bio-Rad

Remove the bottleneck of purifying therapeutic monoclonal antibodies (mAbs) for screening. Save time and increase productivity by automating multicolumn purification during drug development on the NGC Chromatography System.

Effective Removal of mAb Aggregate Using Ca++Pure-HA® (Hydroxyapatite) Media with Potassium Salts

Tosoh Bioscience LLC

A purified monoclonal antibody (mAb) sample, post-protein A purification step was loaded onto a Ca++Pure-HA (Hydroxyapatite) column. Using potassium phosphate buffer as a loading buffer and potassium chloride as an elution buffer, the mAb aggregate content was reduced from 6.6% to as low as 1.3%.

Purification of Large Biomolecules with New Anion Exchange (AEX) Resin

Bio-Rad

IgM antibodies are one of the fastest growing groups of diagnostic and therapeutic candidates. Unlike IgGs, IgMs cannot be purified by affinity chromatography due to their physiochemical properties. The large size of IgMs presents a purification challenge. A new AEX resin has been developed to overcome the multiple issues faced when purifying large biomolecules.

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