Author Archives: Cheryl Scott

Conference Report: The Drug Product Track at 2017’s BioProcess International Conference and Exhibition in Boston, MA

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At the Hynes Convention Center in Boston, MA, during Knect365’s “Biotech Week Boston” in late September of 2017, one track of the BioProcess International Conference focused on drug products, fill–finish, and formulations. Presenters represented a number of major biopharmaceutical companies — AbbVie, Amgen, Biogen, Eli Lilly, Genentech (Roche), GlaxoSmithKline, Johnson & Johnson, Lonza, Pfizer, and Sanofi — as well as suppliers Bosch, Merck (MilliporeSigma), ReForm, and Single-Use Support. They focused on predictive modeling, quality by design (QbD) and process analytics,…

February 14, 2018

December From the Editors

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On the night of Wednesday, 27 September 2017, the fourth annual Battle of the Biotech Bands raised US$110,000 for the bands’ selected charities. More than 800 guests enjoyed refreshments at the Royale Nightclub in Boston and watched Led Zymmelin (pictured right, representing Sanofi Genzyme) walk away with the top prize. They raised money for the National Organization for Rare Disorders (NORD). The crowd was a mix of Biotech Week Boston attendees; arts and entertainment critics; developers, contractors, architects, engineers, furniture…

December 13, 2017

Introduction: Fast Trak Services Accelerate Global Biopharmaceutical Development

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As the need to accelerate biopharmaceutical development around the world continues to grow, biomanufacturers face a host of challenges so they, too, can grow. Increasing process productivity, reducing cost, mitigating risk, and bringing products to market faster are just a few of the issues frequently addressed. But with support in process development, cGMP manufacturing and training, accelerating bioprocess development can become less challenging. Several biomanufacturers have successfully navigated these issues in collaboration with GE Healthcare’s Fast Trak Services. Whether it…

November 22, 2017

September From the Editor

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BioProcess International and the BPI Conference are a bit like twins in that they were born together, but one arrived just ahead of the other. The magazine evolved from a close relationship between its founders and the staff of “IBC Life Sciences” just after the turn of the century. And as we got the publication going back in 2002–2003, we realized that four separate IBC meetings could come together as one under its banner and now-familiar logo. We’ve been colleagues…

September 19, 2017

BPI Lab: Essential Technologies for Development, Characterization, and QA/QC

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There’s a secret hiding in plain sight: many analytical methods and technologies initially designed for pre-clinical development have equally important applications in commercial development. BioProcess International and BioTechniques, sister publications and leading journals that combined, cover the entire biopharmaceutical process, from discovery to development and manufacturing, partnered to create this special eBook, highlighting and detailing fourteen analytical technologies that provide laboratory technicians and scientists with vital information to help project managers and engineers make educated decisions that ultimately affect every…

June 8, 2017

Continuous Processes: Disposables Enable the Integration of Upstream and Downstream Processing

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Despite decades of advancement in characterization analytics, biotherapeutics still are largely defined by the manufacturing processes used to make them. This linking of process to clinical results (and thus to commercial success) has made the biopharmaceutical industry somewhat risk-averse when it comes to the adoption of new technologies. That desire to “derisk” biomanufacturing through better process understanding — as well as the need to adapt to uncertainties in patient population size through process flexibility — in turn drives the need…

May 19, 2017

Introduction: Tackling the Technical and Regulatory Challenges of Biosimilar Development

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In a just a few years, the biopharmaceutical industry has gone from questioning the feasibility of “follow-on biologics” (around the time of BPI’s first issues) to fearing them (when we published our first supplement on the topic in 2013) to the acceptance and strategizing of today. Perhaps because of its more socialized medicine, Europe led the way in biosimilar regulation and approved its first such product nearly 10 years before the first US biosimilar launch in 2015. In between came…

April 18, 2017

Going After a Moving Target: New Production Methods Aid in the Flu Fight

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The traditional method of manufacturing vaccines for influenza involves infecting hens’ eggs with the virus, then harvesting and purifying the large amounts of virus that they produce as a result. It’s time-consuming and expensive, requiring large specialized facilities for production. With the advent of genetic engineering and decades of improvement in protein production through cell-line engineering and industrial culture, it was only a matter of time before the vaccine industry saw the real value in modern biomanufacturing instead (1, 2).…

April 13, 2017

From the Editor

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This issue introduces an adjustment to our themes of coverage, which for much of BPI’s history have rotated from production to processing to manufacturing, with the introduction a few years ago of the “bioexecutive” focus in December. My somewhat pedantic nature always was slightly offended by the idea of separating “manufacturing” from two other themes that were also elements of manufacturing themselves, even though it was mostly just a matter of semantics. And our new product-development theme encompasses much of…

March 20, 2017

Downstream Disposables: The Latest Single-Use Solutions for Downstream Processing

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Downstream processing has been considered a “bottleneck” in the manufacture of protein biotherapeutics ever since cell culture engineers began dramatically improving production efficiencies around the turn of the century. And as single-use technologies have grown in importance and acceptance, offering more solutions every year, their biggest challenges too have been in the separation, purification, and processing that follows product expression in cell culture. Many of the technologies familiar to process engineers — e.g., centrifugation and chromatography — present technical and…

January 20, 2017