Author Archives: S. Anne Montgomery

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…

The Need for Adherent Cell Manufacturing: Production Platform and Media Strategies Drive Cell Production Economics

Most commercial biopharmaceuticals originated from academic research laboratories and start-up development laboratories. Despite such products having differences in modalities and targeted disease indications, and whether their target patient populations are relatively small or approaching blockbuster status, at a key point in development, biopharmaceutical production must scale up from laboratory to commercial production. That movement from research to development and then to manufacturing forces attention on economics and speed to market, and it drives innovative approaches to producing biopharmaceutical cell compositions…

October From the Editor

As we send this issue to the printer, the BPI editors are enjoying the start of the western Oregon fall season. Early rains are beginning finally to extinguish the remaining wildfires that have kept our valley (along with much of the west coast) choked with smoke much of the summer. With the fires on this side of the country and the recent storms to the east, we hope that all our colleagues and readers remain safe. For BPI, changes begun…

Big Biotech Data: Implementing Large-Scale Data Processing and Analysis for Bioprocessing

Managing large amounts of data presents biopharmaceutical companies of all sizes with the need to adopt more efficient ways to handle the ongoing influx of information. At KNect365’s September 2017 Cell and Gene Therapy conference in Boston, Lisa Graham (founder and chief executive officer of Alkemy Innovation, Inc. in Bend, OR) spoke about the need for data management, data analysis, and process monitoring systems to evolve. Although she was speaking at a cell therapy event, her points are applicable to…

Cultivating Better Working Relationships with Contract Manufacturing Organizations: A Panel Discussion

On 21 March 2018, a panel discussion during BPI West in San Francisco addressed ways to improve working relationships between sponsors and contract manufacturing organizations (CMOs). Our goal as organizers was to avoid retreading overfamiliar ground: Many outsourcing articles stress the importance of good communication without delving into actual strategies for improvement. So I asked the panelists to focus on the word better and what that actually means in this context. The most productive way to approach such a discussion…

May 2018 From the Editor

So many manuscripts we receive begin by mentioning the “ever-growing” or “ever-expanding world of biopharmaceuticals.” For anyone who’s been covering this industry for a while, that’s an understandable impression — but it’s not always easy to express. Despite increasing in maturity, that “world” remains on the cutting edge of science and technologies for innovative therapeutic development, and its entrepreneurial spirit remains strong. But we’re all accessing information in different ways now than in the past. We need and want that…

Flexibility, Automation, and Leadership: Drug-Sponsor Perspectives on Modern Biomanufacturing Facility Design

The title of this featured report — Smart(er) Facilities — came about in conversations with our KNect365 colleagues as they worked to plan this year’s BPI West conference, which took place 19–22 March 2018 in San Francisco, CA. For decades, biopharmaceutical facilities have incorporated cutting-edge designs for supporting processes, products, and human development. Each year, design innovations are rewarded for creating workspaces that facilitate both worker comfort and essential movement of promising drug candidates toward commercialization. In that context, biomanufacturing…

Driving Cell Therapy Innovation: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

After many trials and errors — and milestones — regenerative medicine has become a mainstream part of the biopharmaceutical industry, supported by at least 670 companies and clinics of all sizes. But many experiences in the protein-based industry segment can be leveraged to further improve successful commercialization of advanced therapies. At the 2017 Biotech Week Boston conference, BioProcess International editor in chief Anne Montgomery hosted a panel of industry cell therapy experts to discuss key lessons that can be gleaned…