Author Archives:S. Anne Montgomery

eBook: Speed to IND — Practical Wisdom for Uncertain Times

即使在“正常”的时候,公司需要平衡time to filing an investigational new drug (IND) application against careful consideration of processes that can have far-reaching consequences on the quality of biologic products. But supply-chain interruptions still feature prominently in the news during the ongoing COVID-19 pandemic. From equipment to chemicals to plastic components, end users, their suppliers, and (critically) their suppliers’ suppliers all are feeling growing uncertainty about production timelines and availability of materials. In this eBook, BPI’s editor…

October 2021: From the Editor

With autumn beginning to assert itself, our days here in Oregon are cooler, and long-awaited rain is coming. From drought and wildfires to tropical storms and flooding around the globe, we hope that you and your loved ones are making it through this year’s extreme weather events unscathed. And we continue to wish you well through the continuing healthcare crisis. Autumn is time for the annual BPI Conference (including its parallel cell and gene therapy track), held as a hybrid…

September 2021: From the Editor

Amid the continuing frustrations of this time, we are beginning to see what conducting business in a post-COVID-crisis world will be like. A new survey conducted by our Informa Connect Life Sciences group compares responses with those from similar questions in April 2020 — knowing more than we did before about the impact of COVID-19 around the world. The data reveal insights into how the global life-science community has responded to the crisis, the impact the pandemic has had on…

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…

June 2021: From the Editor

We’ve reached midyear 2021 and our last regular issue until September. You will receive our annual Innovators issue in August. Along with it will be the (also yearly) featured report summarizing presentations from the BPI Theater at the Biotechnology Innovation Organization (BIO) International Convention. BPI strives to maintain a balance of thought leadership from different groups in the industry ecosystem: end users, academic researchers, suppliers, contractors, regulators, and consultants. And we focus on specific bioprocesses for each product modality —…

May 2021: From the Editor

不管什么遮阳帽c you delve into these days in the biopharmaceutical industry — e.g., process development, market projections, equipment scaling, quality control, regulatory harmonization — you’ll find a tangled web. Development of vaccines and therapeutics for prevention and treatment of COVID-19 continues to play out against the backdrop of unrelated products in development and others already on the market as short-term manufacturing needs and diversions of contract capacity shift the industry’s focus. This issue provides only a snapshot of…

eBook: Chromatography Resins — Addressing Challenges in Biologic Purification Workflows

Although chromatography remains the backbone of downstream workflows, selecting appropriate technologies to optimize processes can be challenging. Numerous resin options are available, and the fact that most biologics are large, complex, and inherently unstable further complicates development of a robust workflow. Because chromatography processes can alter a biologic in ways that could impair its intended therapeutic function, investment in process development is critical. Techniques such as design of experiments (DoE) can be used to identify the best approach during process…

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…