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Rapid HCP Immunoassay Kit Selection: One HCP Kit Does Not Cover All Possible HCP Mixtures

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Host cell protein (HCP) levels in biologics are on the critical path for assessing product quality, and they pose a serious risk to drug safety. The challenge is to accurately quantify a complex mixture of HCP impurities, which vary in properties and abundance depending on cell line, media, and process parameters. HCP immunoassay analysis is based on polyclonal antibodies raised against HCPs from nontransfected cell lines. How well a particular HCP assay recognizes all proteins depends on how well the…

August 10, 2016

Maximize Your Discovery and Development Productivity with Automated nanoDSF

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Assessment of thermal stability parameters of biologics is an integral part of biopharmaceutical research. The ever-growing number of biologics in development pipelines worldwide demands rapid and precise methods to quickly screen large sets of conditions in an easy and straight-forward manner. In a recent study, we compared two methods for detection of thermal unfolding transition temperatures (Tm) of a therapeutic monoclonal antibody (MAb): nanoDSF, which analyzes changes in the fluorescence emission properties of proteins, and differential scanning calorimetry (µDSC), which…

August 10, 2016

TOYOPEARL NH2-750F: Flow-through Removal of Endotoxin

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Endotoxins are remnants of bacterial cell walls that may contaminate drug products and cause an immunogenic response. They are often referred to as “pyrogens†due to their fever-inducing effects. Endotoxins may be found in drug products either due to contamination from host cells used to produce a drug product in a bacterial expression system or due to adventitious bacterial contamination in non-microbial products. Thus, endotoxin clearance is a requirement of downstream processing of biologics, especially those derived from microbial expression…

July 26, 2016

Letter to Readers

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  Thank you for taking the time to view our supplement, which has been driven by our desire to share actionable knowledge in a convenient format as well as to act as a guidepost for the evolution of continuous processing. As you read, we encourage you to ask questions, share your thoughts, or send general input/requests to our team at www.pall.com/ continuous-questions. We hope that this supplement encourages a deeper discussion about continuous bioprocessing technology and the dramatic impact it…

June 27, 2016

The History of Continuous Processing: Why Has the Biopharmaceutical Industry Been So Late to Adopt?

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Continuous and semicontinuous manufacturing systems have been used for many years in numerous sectors — including the automotive, food and beverage, oil refining, chemicals, pulp and paper, electronics, metal smelting, steel making, and waste-water treatment industries. Most of these industries are capital intensive and switched to flow manufacturing to increase productivity and flexibility; reduce cycle times, inventory, waste, and costs; and achieve enhanced product quality. Despite the capital intensive nature of drug manufacturing, the biopharmaceutical industry has lagged behind these…

June 27, 2016

Moving One Unit Operation At a Time Toward Continuous Biomanufacturing: An Overview of Pall Solutions for Integrated Continuous Biopharmaceutical Production

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Numerous industries have demonstrated that continuous manufacturing provides significant benefits and advantages, ranging from reduced capital and operating expenses to greater efficiency and product quality and consistency. The conventional approach to biopharmaceutical manufacturing involves the batch performance of a series of unit operations separated by hold steps requiring additional tanks and/or biocontainers. Such an approach fails to maximize facility use, requires large buffer volumes, and results in overall inefficiencies. An integrated, continuous approach to bioprocessing connects each unit operation, minimizing…

June 27, 2016

Preparing for Continuous Bioprocessing: An Interview with Pall Corporation’s Chief Technology Officer Martin Smith

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Martin Smith, PhD, has been with Pall for about nine years and assumed the role of chief technology officer at Pall about 18 months ago. He spoke with Cynthia Challener, PhD, about Pall’s biopharmaceutical business unit and how the company is positioning its technology suite for a continuous process paradigm. Smith: There is no doubt in our minds that we see movement toward continuous bioprocessing. When you look across an array of different industries, the move to continuous or parallel…

June 27, 2016

Regulating Quality in Continuous Processing

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Regardless of the industry and product being manufactured, continuous processing has demonstrated numerous benefits. In addition to smaller manufacturing footprints, reduced material consumption and waste generation, increased efficiencies, and lower capital and operating costs continuous manufacturing typically leads to more consistent processes and product quality. In the pharmaceutical industry, the latter two attributes align perfectly with FDA’s Quality by Design (QbD) and process analytical technology (PAT) initiatives. The challenge is determining how to apply these concepts in practice. Applying the…

June 27, 2016

Moving Toward a Continuous Future

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During the March 2016 BPI West conference in Oakland, CA, BPI publisher Brian Caine and I had an opportunity to meet with Michael Egholm, PhD, Vice President and General manager of Biopharmaceuticals at Pall Life Sciences. We are pleased to be able to share his thoughts about Pall’s support of continuous processing — and the company’s current offerings. Montgomery: Not everyone seems to be defining continuous processing in the same way. What is your general concept of it? Egholm: At…

June 27, 2016