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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Endotoxins Standards and Their Role in Recovery Studies: The Path Forward

Posted on September 14, 2017

The USP General Chapters – Microbiology Expert Committee (EC) is the steward in the United States of harmonized Chapter <85>, “Bacterial Endotoxins Test”, or BET (USP 2016a). The EC has closely followed the Low Endotoxin Recovery (“LER”) discussion and publications since the interference was first described in 2013 (Chen and Vinther, 2013). It is important […]

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Low Endotoxin Recovery: An FDA Perspective

Posted on September 8, 2017

Abstract The Code of Federal Regulations, 21 CFR 211.167(a), requires that any drug product claiming to be sterile and non-pyrogenic be tested for conformance for sterility and endotoxin. In addition, 21 CFR 610.13(b) requires that any biological product intended for use by injection be tested for pyrogenic substances by intravenous injection into rabbits. The rabbit […]

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

Posted on August 22, 2017

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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Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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Protein A affinity chromatography represents the key initial capture method in monoclonal antibody (mAb) purification. There are three major types of protein A “resin” based on a different matrix chemistries – glass, agarose and synthetic polymer. State of the art resins must offer good specificity, high mass transfer and binding capacity, low non-specific adsorption, low ligand leakage, suitable back pressure […]

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

Posted on August 15, 2017

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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New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

Posted on August 8, 2017

Introduction Biological products, biologicals or biologics are important class of drugs used in diagnosis, prevention and treatment of disease. These products are made from natural biological sources, including humans, animals and microorganisms, often made in cells, tissues, microorganisms and whole animals or by recombinant or genetic engineering techniques. Regulation of products used in the treatment […]

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Single Use Systems in Biologics Manufacturing and their Impact on Manufacturing Execution System (MES)

Posted on July 27, 2017

Since their inception in production, single use systems (SUS) have evolved and improved thanks to the continuous relationship between vendors and biopharmaceutical manufacturers, accommodating a wide range of operational needs. From culture initiation in small volume bags, to large-scale production bioreactors, chemical solution preparation and product storage, the implementation of single use technologies is a […]

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Continuous processing optimization with smarter tools

Posted on June 30, 2017

  Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative ways to quickly and […]

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The future of biomanufacturing

Posted on June 29, 2017

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exists a lag in automation and measurement to make the most use of the technology and data integration. Next challenges in biomanufacturing The next set […]

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