BioPharm International’s Biopharma Knowledge Resources Newsletter:
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BioPharm
October 23, 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.

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 Featured App Note

Antibody Affinity Extraction for HCP Analysis

Ken Hoffman and 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.

Formulation

Whitepaper: Optimizing Excipient Properties for ODT Formulation

Roquette

Orally disintegrating tablets (ODTs), also known as orodispersible tablets, are unique dosage forms formulated to improve their in vivo disintegration and dissolution rates. It is a big challenge to ODT producers to achieve a minimum disintegration time while keeping formulation simple and robust.
The required advances in pharmaceutical manufacturing occurred when excipient suppliers developed multi-functional types for direct compression. Roquette’s PEARLITOL® Flash, a combination of mannitol and starch, is a ready-to-use excipient for orodispersible tablets. This article describes its application to formulation and how this delivers advantages like robustness and rapid disintegration time. PEARLITOL® Flash means problem-free ODT formulation.

Downstream Processing

A High DBC Protein A Resin Designed to Reduce Production Costs

Tosoh Bioscience LLC

This report details how using a high DBC protein A resin to reduce productions costs on a per-gram of monoclonal antibody (mAb) without making any sacrifice to product quality or processing time.

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