Author Archives: S. Anne Montgomery

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…

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…