2019

Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

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With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the…

May 15, 2019

Funding Pediatric Cancer Drug Development

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Why is it so hard to develop drugs for children with cancer? And what can be done about it? Those questions are central to a Massachusetts Institute of Technology (MIT) study published in JAMA Oncology exploring new business models for funding drug development to treat pediatric cancers (1). Led by Andrew W. Lo (the Charles E. and Susan T. Harris professor at and director of MIT’s Laboratory for Financial Engineering) finds that a collaborative investment structure involving money from private-sector,…

May 15, 2019

Ask the Expert: Acoustic Cell Processing

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As cell and gene therapies approach commercialization, the industry is looking for scalable manufacturing solutions. Equipment providers need to design specifically for the good manufacturing practice (GMP) environment and the unique needs of cell and gene processing. On 3 April 2019, Kevin Lannon of FloDesign Sonics presented an “Ask the Expert†on one company’s solution. LANNON’S PRESENTATION In a typical cell therapy manufacturing process, steps that require washing, concentration, or buffer exchange include centrifugation, filtration, and counterflow filtration. Each has…

May 14, 2019

Cell Culture Bioprocessing in Perfusion: Assessing Cell Retention Technologies

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Upstream bioprocessing in perfusion mode holds great promise for industrial production of cells and biologics. In perfusion, fresh medium is added constantly to the bioreactor, and used medium is harvested while the cells are retained in the bioreactor. As a result, the composition of the cell culture medium stays quite constant during the process. This offers several advantages. In perfusion, higher cell densities can be reached than in batch and fed-batch processes, therefore enhancing volumetric productivity. Because medium composition can…

May 1, 2019

eBook: Making Filtration Work

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Steady improvements in batch-fed cell culture have led to bottlenecks in downstream processing. Filter suppliers are working to improve available tools for purifying therapeutic proteins, to wring every possible efficiency out of those tools, and to make them operate together harmoniously. The combination of high titers and high-value products places a premium on preventing yield loss. Bioprocessors want to optimize filtration primarily for cost reasons. In this eBook, author Angelo DePalma discusses financial aspects, clarification/harvest and virus filtration options, and…

April 25, 2019

A Harmonized Approach to Data Integrity

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Data integrity is achievable when data collection is complete, consistent, and accurate (1). Failure to maintain data integrity compromises a company’s ability to demonstrate the safety and efficacy of its products. Escalation of serious regulatory actions related to data integrity violations has prompted the need to assess data integrity compliance and implement systems designed to guarantee it. Comprehensive measures must be taken to ensure that data are attributable, legible, contemporaneous, original, and accurate (ALCOA) (2). Preventive measures need to be…

April 23, 2019

Opportunities for Modern Robotics in Biologics Manufacturing

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It should come as no surprise to anyone familiar with biomanufacturing that current designs of bioprocess facilities as well as associated manufacturing spaces and support operations require excessive amounts of manual labor and manual interventions that lead to high labor costs and, consequently, total cost to supply. From receipt of raw materials to process execution and performance review, resolution of quality issues, and product shipping, no industry devotes a greater percentage of operating costs (or cost of goods sold, CoGS)…

April 23, 2019

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

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Control charts are used to assist in process monitoring activities. They use an estimate of central tendency (the overall mean) and variation (the standard deviation). Sample standard deviations (S) tend to underestimate process standard deviations (σ) when they are calculated using limited sample sizes of independent results (1). For this reason, the unbiasing constant c4 is used as a divisor when calculating Shewhart control-chart limits. If data used for control charting are positively autocorrelated, that tends to underestimate σ further…

April 23, 2019

Antibody Derivatives: Deconstructing MAbs for the Next Wave of Biotherapies

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Although they make up the largest and most successful category of biopharmaceuticals so far, monoclonal antibodies (MAbs) suffer from certain disadvantages. Some companies are addressing those limitations by deconstructing MAb molecules to create new emergent therapeutics. These antibody derivatives include: antibody fusions and fragments, bispecifics, trifunctional antibodies, and more. This eBook combines market analysis from consultant David Orchard-Webb with technical discussion from BPI cofounder and senior technical editor Cheryl Scott. It also includes commentary from editorial advisor Michiel Ultee and…

April 19, 2019

April From the Editor

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Our focus on regenerative medicine this month, with its inherent personalized approach, brings to my mind aspects of “the patient experience.†Last week at BPI West in Santa Clara, CA, I was intensely moved by the performance of lymphoma survivor Toby Peach (www.tobypeach.co.uk). Our KNect365 colleagues will be asking him back this fall for the BPI Conference in Boston, and I encourage you not to miss him if you’re there. Many of us will be touched by some form of…

April 18, 2019