Author Archives: S. Anne Montgomery

eBook: mRNA — Revisiting a Technology That Has Rocketed into Success

At the end of 2018, BPI published its first eBook about mRNA drug products — and quite a lot has happened since then! Our initial report highlighted companies working on mRNA therapeutics for cystic fibrosis, heart disease, and cancer, as well as vaccines. The latter approach took off in 2020 with the advent of SARS-CoV-2 and the COVID-19 pandemic, and in a stunningly short time, the biopharmaceutical industry has learned much about manufacture, formulation, product design, and distribution of mRNA…

January–February 2021: From the Editor

With this issue, BPI celebrates its 19th birthday. I have pretty much run out of words to talk about the year we all just endured and the changes we’ve had to make in our lives to sustain our families, businesses, and overall mental and physical health. We editors want to respond appropriately to the complex issues currently facing the biopharmaceutical industry. But with so many technologies advancing so quickly, it’s difficult for a (mostly) monthly publication such as ours to…

November–December 2020:
From the Editors

As 2020 draws to a close, we can’t help looking back at this year in which the biopharmaceutical industry has received more attention than ever before — scientifically, politically, and otherwise. We editors always have been conscious of (and pretty good at) separating our work and home lives. As many of you have learned this year, that’s an important part of working from home, which we’ve been doing for over a decade. But in recent months, reading the news and…

October 2020: From the Editor

This issue has been created by editors living in over-the-top levels of wildfire smoke here in Oregon’s Willamette Valley. Although all of us have been safe, we are appalled at the widespread loss of property and lives over these past two weeks. Amid those losses, and against the backdrop of political and social upheavals, the coronavirus continues to wreak its own havoc on just about every aspect of our lives. Adding natural disasters and subsequent loss of homes and possessions…

From the Editor: June 2020

BPI’s June issue always precedes a break in our regular issue schedules in July and August. But summer does not afford us any leisure. This July, we again shall bring you an eBook of summaries from the BPI Theater at the Biotechnology Innovation Organization’s annual convention (this year from digital presentations, which will be available in full on the BPI site) along with our annual Industry Innovators issue. Summer eBook topics will be formulation, exosomes, biosimilars, and expression systems. BPI’s…

From the Editor: May 2020

In this way-too-interesting time we’re living through, we are seeing the worst and best of humanity as we do what we can to protect ourselves and our families. When we can congregate again, some of us will be relieved to abandon home offices and get back to familiar work surroundings, social interactions, dependable Internet access, and company-provided toilet tissue. Others will have learned that working from home is the greatest thing next to sliced bread and lobby with their management…

March 2020: From the Editor

My first business trip each year usually is to Washington, DC, in January. There, the CMC Strategy Forum and WCBP symposium (sponsored by CASSS have an excellent track record of setting the stage for topics that will play out through the rest the year. The combined event draws significant US Food and Drug Administration participation. So we also look forward to their help in focusing our attention on key regulatory issues and updates. With continuing focus on well-characterized biologics, WCBP…

eBook: Joining Forces — Industry Collaborations Toward BioProcess Success

Companies in the biopharmaceutical industry increasingly are working together to solve the many challenges of product/process development and biomanufacturing. Suppliers seek end-user help in refining technologies; academics and small innovators attract the financing and business acumen of large companies; equal partners share in technological problem-solving; and sponsors engage the development expertise of contract research and manufacturing organizations. Other examples of biopharma industry collaborations abound, too. Citing critical examples from the September 2019 BioProcess International East Conference in Boston, MA, this…

eBook: Speed to IND — Balancing Risk and Reward

With so many biopharmaceuticals obtaining breakthrough or fast-track designations, companies that use accelerated strategies to be first in human studies can be left with significant quality and manufacturing challenges that must be solved later on. Despite regulatory encouragement to create solid design spaces and define parameters according to quality by design (QbD), those may go by the wayside given the pressures of speed. The reward is the investigational new drug (IND) application itself — but if companies lock in subpar…

BioProcess International 2019 Event Report

The 2019 BioProcess International Conference and Exhibition, held in Boston, MA from 9–12 September, was a testament to the rapid expansion of the biopharmaceutical industry. Nearly 150 speakers chronicled recent developments and continuing challenges in upstream production, downstream processing, drug product manufacturing, and emerging therapies production. And with more than 150 poster presentations and over 200 companies participating, the BPI exhibit hall never better embodied the industry’s efforts to support increasingly diverse but related audiences. In this event report, BioProcess…