Author Archives: Cheryl Scott

Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities

New technologies bring new regulatory challenges. The biopharmaceutical industry must be cautious in its implementation of new scientific ideas and technology platforms — no matter how promising those might be. Regulators will look skeptically on any claim that isn’t backed up by good data, and with no solid history of successful use to build on, a company must have all the answers itself. How do compliance professionals anticipate what kinds of questions reviewers will ask when the time comes —…

Science Guiding Technology: Cell Line Development and Engineering 2018

Cell line development engineers in the biopharmaceutical industry juggle several, sometimes contradictory priorities. They must present their bioprocessing colleagues with a master cell line that can express a reproducibly high-quality protein product at titers and growth concentrations that will be high enough for manufacturing efficiency — and without those parameters degrading over time. Performing the first step in every bioprocess, these scientists must consider their own budgetary concerns and efficiencies while facing regulatory scrutiny under the 21st-century risk-management paradigm. In…

September 2018 From the Editor

Magazine editors live in a strange warped time frame. We put the finishing touches on this very September issue in mid-August, having begun working with the materials a month before that. Meanwhile, we’re in talks with authors and companies who will be contributing to the pages of our October and November–December issues and inserts. Anne is working already to acquire manuscripts for the early issues of 2019. When it comes to eBooks, however, we actually put them together during the…

June From the Editor

It surprises some folks in the BPI community to learn that I’m a journalist by training, boasting a mere bachelor of arts degree in journalism despite my high-fallutin’ technical editor title. I was originally trained in Associated Press (AP) style by a veteran newsman who spent many years working for AP’s main competitor, United Press International (UPI). When I first started on BioPharm back in 1996, I had to get up to speed quickly on the stylebooks of Chicago and…

eBook: Bioprocess and Analytical Laboratories — Proving the Power of Data in Drug Development

Analytics pervade the entire biopharmaceutical development process — from protein characterization through biomanufacturing process optimization to final-product formulation and clinical testing. Every technical article in BPI requires data to back up the statements made, whether the topic is upstream/production, downstream processing, product development, or otherwise focused. And never mind publishing: Even more detailed documentation is required for regulatory submissions. If a company can’t back up the choices made and results obtained in development, manufacturing, and testing of its biopharmaceutical product,…

April From the Editor

A friend of mine was returning home from a vacation in Rome this week, and her flight from Europe to Newark was delayed and diverted because someone’s child had measles on the intended connecting plane. Measles! Someone thought it was okay to spread that around. Often as we put together a themed issue — whether focused on a manufacturing pillar or something new like this month — a subtheme seems to just happen. This month, thanks to authors from Biogen…

March From the Editor

Are you protecting your trademarks? Are you sure? You’ll notice that BPI doesn’t use registration marks (e.g., ™ and ®) anywhere but in advertisements and the occasional “advertorial” piece. Ever wonder why? According to the official stylebook of the American Chemical Society, which is the basis of our “house style,” they are entirely unnecessary. And editors everywhere dislike the impression they give as well. On page 157 of the ACS stylebook, trademarks (“brand names”) are defined as adjectives that describe…

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

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,…

December From the Editors

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…

Introduction: Fast Trak Services Accelerate Global Biopharmaceutical Development

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…