Author Archives: Cheryl Scott

Single-Use Fill and Finish: An Interview with NNE Pharmaplan

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I talked with NNE Pharmaplan’s Kim Vincent Andersen (single-use technology and biotechnology specialist) and Niels Guldager (global technology partner in biotech) to discuss their experiences with client facilities that incorporate significant elements of single-use technology. In particular, they highlighted a recent project for Novo Nordisk involving a large-scale greenfield filling and inspection facility in Hillerød, Denmark. Find more detailed information about the project online at https://goo.gl/yp4LQh. And you can watch a video about it here: https://youtu.be/czwwgdt3CxI. A Case Study You…

January 20, 2017

Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates

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The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment will continue to…

November 17, 2016

Outsourcing and Biomanufacturing Challenges for Emerging Therapies: A Roundtable Discussion at BIO 2016’s BPI Theater

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The biopharmaceutical industry is increasingly interested in a range of emerging therapies. “We’re really starting to get beyond the monoclonal antibody,” said Patricia Seymour (senior consultant with BioProcess Technology Consultants) in her introduction to a lunchtime BPI Theater roundtable at the 2016 Biotechnology Industry Organization annual convention in San Francisco, CA, this past June. The discussion brought together three industry insiders for strategic outsourcing to talk about emerging biotherapies and their manufacturing challenges: Mark Angelino (senior vice president of pharmaceutical…

September 15, 2016

CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview

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Introduction by Cheryl Scott The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment…

April 12, 2016

Choosing Between Single-Use and Multiuse Technologies: An Interphex 2015 Roundtable Discussion

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On Tuesday, 21 April 2015, Eric S. Langer (managing partner at BioPlan Associates) chaired a midday roundtable titled, “Deciding on Single-Use vs. Stainless Steel Bioprocessing Strategy: What Do CMOs Know That Biopharmas Don’t?” Langer brought together several industry experts to discuss choosing between stainless steel and single-use technologies (SUTs) for different applications: William Hartzel (director of strategic execution at Catalent Pharma Solutions) Steven Perry (vice president of technical operations at Cook Pharmica) Joanna Pezzini (bioprocess engineer at MedImmune) Daniel Vellom…

December 18, 2015

From Chips to CHO Cells: IT Advances in Upstream Bioprocessing

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Advances in our capabilities for data acquisition, storage, and manipulation are providing the biopharmaceutical industry with an increased understanding of what must be controlled in bioproduction as well as the ability to control it. Developments in hardware, processing algorithms, and software are changing the landscape of bioprocess administration. Increased power for information gathering and processing began with the remarkable increases in microprocessor speed, pipelining, and parallelism over the past couple of decades (1); it continues with advances in data handling…

December 16, 2015

Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction

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The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment will continue…

November 17, 2015

Spotlight

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Niche Disease: Legionnaires’ Disease by Cheryl Scott Gram-negative, aerobic Legionella pneumophila bacteria were first identified as the cause of an outbreak of severe pneumonia at an American Legion Convention in a Philadelphia convention center in 1976. Since then (and probably long before), it has been responsible for occasional such outbreaks around the world. For example, an epidemic of the disease probably occurred in Minnesota in 1957. Such incidents are usually associated with poorly maintained artificial water systems (e.g., cooling towers…

October 15, 2015

Elucidation on India and China: Powerhouses of Asia 2015 Reports Assess Their Pharmaceutical Markets

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In the past year, CPhI Worldwide (a division of UBM EMEA) has released reports on both the Indian and Chinese pharmaceutical markets, findings of which were presented at CPhI India in Mumbai in early December 2014 and shortly after CPhI China in August 2015. India Looking Outward to Innovate The Indian report, CPhI India Pharmaceuticals 2015: Industry Explorations, was developed by CPhI in partnership with Global Business Reports (GBR) to provide a comprehensive analysis of the country’s pharmaceutical market. Overall, Indian companies…

October 15, 2015

Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction

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The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with…

September 23, 2015