Changing Column Packing from an Art into a Science

Posted on December 12, 2017

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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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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Keys to Successful Implementation of Single-Use Technology

Posted on December 12, 2017

  How and why collaboration improves single-use products Willem Kools, PhD., Head of Technology Management, Merck As biopharmaceutical projects occupy an increasingly larger share of the development pipeline, drug makers are striving to implement strategies that bring affordable therapies to market quickly and cost effectively. Over the past several years, the adoption of singleuse technology […]

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Merck Podcast – Biopharm Intl M Lab Single Use

Posted on November 15, 2017

Biopharm Intl M Lab Single Use Podcast-Merck from Adam Young on Vimeo.

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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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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

Posted on August 22, 2017

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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Process Analytical Technology for Upstream Bioprocessing

Posted on June 16, 2017

Summary In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence […]

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Implementing global best practices and technology specifications for single-use systems

Posted on April 12, 2017

How does your global company share internal expertise, best practices and specifications? Do you have platform technologies globally? Is it easy to find out what has been learned at other manufacturing sites? If not, opportunities exist for speed to market, elimination of redundant work, and cost savings. By: Jason Nisler Bioprocessing Application Specialist, CPC – […]

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Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

Posted on April 11, 2017

Summary Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a […]

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FDA’s Office of Pharmaceutical Quality Establishes the Center for Excellence in Manufacturing Science and Innovation Research

Posted on March 28, 2017

In January 2015, the FDA’s Office of Pharmaceutical Quality (OPQ) was stood up as a super office within the Center for Drug Evaluation and Research (CDER). Since then, OPQ has established itself as a global leader in regulatory science and research pertaining to drug product quality. A critical part of CDER’s mission is to ensure […]

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Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Posted on March 17, 2017

Summary Single-pass tangential flow filtration (SPTFF) followed by multi-column chromatography (MCC) was used to continuously process a cell culture supernatant containing a monoclonal antibody (MAb) via Protein A affinity chromatography. This study demonstrates the benefit of such a combination in term of process robustness, productivity and economics of continuous processing. The SPTFF technique can readily […]

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Challenges in the Development of Continuous Processes for Vaccines

Posted on March 17, 2017

Abstract The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity […]

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Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production

Posted on March 3, 2017

Robert Dream, Managing Director HDR Company LLC The importance and value of continuous bioprocessing, both up and downstream. Economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that the industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have […]

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What is holding Industry back from Implementing Continuous Processing: Can Asia Adopt More Quickly?

Posted on February 28, 2017

Biopharma Not Quite Ready to Say Goodbye to Batches Although few biologics today are made using continuous bioprocessing (CBP) equipment like bioreactors—that may be changing. And Asian bioprocessing facilities may have an opportunity to take a more leading role. While it is difficult to displace existing processes for existing biologics, for early stage pipeline biologics, […]

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Is Automation the Disruption Pharma R&D Needs?

Posted on February 8, 2017

Barbara Paldus, PhD CEO and co-founder, Finesse Solutions, Inc., Santa Clara, CA According to a recent report from PhRMA, U.S. biopharmaceutical companies spend more than 13 times the amount of R&D per employee than all other manufacturing industries.1 This is because potential drug candidates require lengthy and complex testing to ensure they are safe and effective […]

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Continuous processing optimization with smarter tools

Posted on December 19, 2016

Barbara Paldus, PhD CEO and co-founder, Finesse Solutions, Inc., Santa Clara, CA Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more costeffective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical […]

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