Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

Posted on July 13, 2018

James Barry, Director of Marketing, Americas Since disposable technologies have demonstrated their numerous benefits and reliability at the development and clinical scales, biopharmaceutical manufacturers are slowly increasing the implementation of single-use systems for commercial-scale manufacturing in upstream, downstream and fill/finish operations. In response to changing customer needs, Pall Biotech has expanded its established and widely […]

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Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Posted on July 13, 2018

Introduction Control of bacterial endotoxins, gram-negative bacteria that can cause pyrogenicity, is critical in the manufacture of pharmaceutical drug products intended for parenteral administration. Unlike bioburden, which can be readily eliminated by terminal sterilization via autoclave or filtration through a 0.22 µm membrane during aseptic filling, bacterial endotoxin is difficult to remove during routine manufacturing […]

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Accelerating the Commercialization of Biosimilar Medicines in India

Posted on July 10, 2018

SSB’s forum discussed the latest developments in bioprocessing and biosimilar development There is a flourishing biosimilar medicine industry in India focussed on the supply of affordable biologics to the domestic market. Regulators in India have already approved over 50 biosimilar drugs. Companies such as Dr Reddy’s, Biocon and Intas Biopharmaceuticals are internationally recognised brands and […]

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Development and Implementation of Process Analytical Technology (PAT) Systems in the Biopharmaceutical Sector – Challenges and Returns

Posted on July 10, 2018

Abstract The Food and Drug Administration’s (FDA) process analytical technology (PAT) initiative encourages pharmaceutical manufacturers to use innovative analytical tools to improve the understanding and control of their manufacturing processes. In-line and on-line process analytics constitute a vital element of the PAT strategy. The utilization of PAT tools to monitor media composition and control specific […]

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Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Posted on July 10, 2018

Protein A chromatography is widely used as the affinity capture step of both mAbs and Fc-fusion proteins because of its high degree of selectivity. Variations in elution behavior of the protein A capture step require more process development work and could have an impact on the polishing step in the downstream process. Thus, minimizing the variation in elution pH between […]

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Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Posted on June 13, 2018

Gene therapy, including oncolytic viruses, where new genetic material is introduced into the body, holds promise to cure or alleviate symptoms of many different diseases. In the last few years, the field has seen rapid growth with at least 11 drugs approved globally. A ClinicalTrials.gov search on the term ‘gene therapy’ returns 734 industry sponsored […]

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Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Posted on June 8, 2018

Monica Cardona and Ian Johnson Purpose The Water Intrusion Test is widely used in the pharmaceutical industry to test the integrity of tank, autoclave and lyophilizer vent filters. The purpose of this document is to present the collected best methods/practices to give filter end users the best possible chance of performing a successful WIT. It […]

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Changing Column Packing from an Art into a Science

Posted on May 11, 2018

Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. […]

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Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Posted on April 25, 2018

The Cadence inline diafiltration (ILDF) device is designed for continuous processing, in-process buffer exchange or contaminant removal in various processes in a wide range of applications in the biopharmaceutical industry. This includes buffer exchange for final drug substance, desalting or buffer exchange before or after column chromatography, and small molecule contaminant removal. The single pump pass […]

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Enabling Total Biopharma Solutions

Posted on December 12, 2017

After a few decades of speculation and proof of concept, the biopharmaceutical industry has fully embraced the advantages of single-use technologies throughout all phases of drug production1. In particular, as industry interest shifts to continuous bioprocessing versus traditional batch methods, the flexibility of single-use technologies has once again emerged as an asset to industry advancement. […]

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Coupling single-pass TFF before loading onto a chromatography sorbent

Posted on September 28, 2017

Process and economic benefits could be achieved by coupling single-pass tangential-flow filtration (SPTFF) and chromatography steps at manufacturing scale. This results in significant sorbent/buffer cost savings and/or reduced processing times. Additionally, the reduced volumes will also help to downsize all future unit operations. As a result, smaller equipment, tank sizes, and hold-up volumes will reduce […]

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