Author Archives: S. Anne Montgomery

June 2019 – From the Editor

Often we are pleasantly surprised at thematic connections that fall within an issue or come between an issue and its supplements — sometimes planned, sometimes a matter of happy coincidence. Setting an issue theme of continuous processing with a featured report on large-scale capacity strategies inevitably created some overlap. At this stage of maturation in its brief history, the biopharmaceutical industry offers myriad choices for facility design, process development, manufacturing paradigms, and partnering arrangements. With many successful examples to choose…

Making Downstream Processing Continuous and Robust: A Virtual Roundtable

Current biomanufacturing is driven to pursue continuous processing for cost reduction and increased productivity, especially for monoclonal antibody (MAb) production and manufacturing. Although many technologies are now available and have been implemented in biodevelopment, implementation for large-scale production is still in its infancy. In a lively roundtable discussion at the BPI West conference in Santa Clara, CA (11 March 2019), participants touched on a number of important issues still to be resolved and technologies that are still in need of…

May 2019 From the Editor

One thing that differentiates Baby Boomers, GenXers, Millennials, and Generation Y is their communication preferences. Who is most likely to answer a call or email, default to texting, or use a given social-media platform? Newer generations of bioprocess professionals are building on the legacies of this industry, and their fresh perspectives are driving innovation. BPI strives to help share that work with as large and relevant an audience as possible — in a range of formats that includes something for…

March From the Editor

The merging of Informa’s KNect365 division with pharmaceutical events operated by UBM brings another opportunity for BPI’s successful “BPI Theater” program: the “BioLIVE” theater taking place at CPhI. Our first foray into the theaters — our own speaker/roundtable sessions held in the exhibit halls of large events — was at a BIO International Convention some years ago. Through our relationship with the Biotechnology Innovation Organization, that came about to bring more technical content into the big event. As BIO grew…

Continuous Chromatography: Experts Weigh in on the Possibilities and the Reality

Discussions of continuous processing in the biopharmaceutical industry are an important part of current efforts toward intensifying bioproduction and bioprocessing. Biomanufacturers are looking at all components of their development and manufacturing processes for ways to reduce the size of their facilities, lower costs, and increase speed and flexibility of operations. Increasing options for and availability of single-use technologies have been major enablers of myriad attempts to improve efficiencies. Although the general consensus may still be that single-use components are more…

Manufacturing Insights: Interviews from BWB 2018 Highlight Perspectives on Streamlining Manufacturing Timelines

Addressing manufacturing and technologies strategies to accelerate market entry is one of BPI’s highlighted themes for 2019. In partnership with our conference colleagues in Informa’s KNect365 division, this already has been a shared theme, reflecting the general goals of the industry and related advice from its regulators. BPI’s summer 2018 preconference ebook included interviews by Dan Stanton (editor, BioProcess Insider) with speakers previewing their talks for the BPI Conference in Boston on 7 September 2018. Two of those conversations focused…

January-February From the Editor

Greetings from the BPI editorial staff — we wish you a healthy and prosperous 2019! Beginning with a combined January–February issue somehow makes the year seem to be speeding by right from the start. We are immersed now in the first radical redesign of our magazine since the publication’s founding in 2003. Some aspects proceed smoothly; others, not so much. You see with this issue a new cover design that ties us in with our KNect365 event brands. You’ll see…

Messenger RNA Drugs: Engaging the Machinery of Patients’ Cells to Therapeutic Effect

Although most of the bioprocess industry has focused on process development for large-molecule formulations (e.g., protein drugs), a growing segment of the industry has been concentrated on other types of biotherapeutics to leverage advances in understanding of immunology and genetic engineering. Such technologies may emerge both as tools for drug manufacturing and at some point, as biopharmaceuticals, biotherapeutics, vaccines, and cell and gene therapies,  themselves. What brings mRNA research to BioProcess International’s attention is the increasing interest turned toward therapeutic…

Introduction: The Ins and Outs of Market Demand

From transport and holding of bulk drug substance to shipping, warehousing, tracking, and distribution of final packaged drug products, biopharmaceutical supply chain logistics can be described as an industry in itself. And that’s just one side of the story. Even though much of the work of establishing and maintaining supply chains might happen outside the manufacturing environment, all organizations that develop processes and final products depend on having the raw materials and available components and resources to do their work.…

Rolling with the ‘Tides: Elucidating the Role of Peptides and Oligonucleotides in the Biopharmaceutical Industry

In earlier issues of BPI we published a few “Elucidation” closers that we called “Defining Moments.” Since then, we have tried to distinguish key confusable terms from one another. Those presented (and sometimes “elucidated”) have been analytical and bioanalytical, spectroscopy and spectrometry, and biosimilars and biobetters. They are just a few of the many confusable terms in the biopharmaceutical industry. For example, when someone says “drug delivery,” a formulator will think of a syringe or transdermal patch, but a logistics…