cofounder and senior technical editor of BioProcess International, rabid nature lover and sci-fi nerd/author, horse and dog owner, cancer survivor
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Articles by Cheryl Scott
Navigating the Complex Landscape of Cell and Gene Therapy Manufacturing
A scientist places a finished cell-therapy product into cold storage before transport to a clinical setting. (https://stock.adobe.com) The cell/gene therapy (CGT) industry stands at a crossroads where groundbreaking science meets the practicalities of manufacturing, regulation, and commercialization.
Distributed Biomanufacturing: Rethinking Production and Logistics for Autologous Cell Therapies
After years of groundbreaking scientific advances in cell and gene therapies (CGTs), the advanced-therapies sector faces a fundamental challenge that has little to do with bioscience itself. The question of whether such therapies work has been settled, more or less: They do, and remarkably well. Many product approvals that demonstrated as much, however, have gone on to highlight the difficulties in manufacturing and delivering CGTs to patients who need them.
eBook: Manufacturing Systems — The Holistic Approach to Commercial Success for Biopharmaceuticals
Commercial biomanufacturing — whether for protein biologics or advanced therapies — is not solely about production scale. Product developers around the world need to combine modern technology platforms with efficient quality systems for regulatory compliance and long-term supply reliability. Modular facilities and single-use technologies are transforming biopharmaceutical manufacturing by enabling greater flexibility, scalability, and cost-efficiency.
From the Editor: Special Edition - The Best of BPI
Cheryl Scott, Editor in Chief, BPI. Welcome to the first of our three special print editions for 2026! These issues are made available exclusively to attendees of our main events across the year: BPI West (San Diego, 9–11 March), BPI Europe (Vienna, 27–30 April), the Biotechnology Innovation Organization’s (BIO’s) annual convention (San Diego, 22–25 June), and the BPI Conference and Exhibition at Biotech Week Boston (22–25 September). We look forward to meeting you when you pick yours up.
Key Collaboration Leads to Success in the East
Asia is emerging as a pivotal region for biotechnology and healthcare innovation, offering unique opportunities for global companies to expand and thrive. In this eBook, BPI’s news editor discusses with a long-time advisor the importance of understanding cultural dynamics such as the concept of guanxi in China, which prioritizes interpersonal relationships over formal contracts.
Intensified Processes
Process engineers continue to seek out improvements to upstream biopharmaceutical production — e.g., through increases in process productivity, cost of goods (CoGs), adaptability, speed, and sustainability. Such improvements might entail process intensification (PI) to increase operational efficiency, use of enhanced expression systems, and more. This eBook explores recent advances among alternatives to traditional fed-batch production processes.
Antibody Engineering — Technological Evolutions Expand the Toolbox
The antibody engineering field is experiencing rapid transformation driven by computational advances and sophisticated molecular architectures. Machine learning and artificial intelligence platforms are dramatically accelerating antibody design, potentially reducing timelines from years to months. Industry and academia are working together to leverage digital models for developability predictions and affinity optimization.
Petra Dieterich | BioProcess International
Allogeneic therapies based on healthy-donor material should help to create scalable processes for “off-the-shelf” drugs, potentially reducing production costs and increasing accessibility, however, developers of allogeneic products also must answer practical questions about where to obtain starting material and how to ensure its quality. This eBook explores solutions for cell sourcing, characterization, and quality control.
From the Editor: November-December 2025
Cheryl Scott, Editor in Chief With this issue, BioProcess International wraps up its 23rd year. We have led our market in many ways over that time, and even as other titles dropped their reader-qualification programs and moved from print to online-only publication, BPI remained a regular and physical presence in thousands of European and North American mailboxes. In every readership survey, year after year, the majority of respondents told us that was what they preferred — and we obliged.
November-December 2025
Cheryl Scott, Editor in Chief, discusses BioProcess International's transition to digital-only in 2026, offering faster publication, while urging industry leaders to defend science and regulatory integrity. Biomanufacturing outsourcing growth is slowing, but political uncertainties, tariffs, and labor shortages are reshaping where production work gets done.
BioProcess International From the Editor: October 2025
Cheryl Scott, Editor in Chief Like many of you, I’m sure, I do not even know where to begin with what’s going on at the US Department of Health and Human Services (HHS). Unlike most of you, however, I’m relatively safe in commenting on it without jeopardizing a company’s regulatory standing.
BPI October 2025: Product Development Issue 2025 - October
Like many of you, I’m sure, I do not even know where to begin with what’s going on at the US Department of Health and Human Services (HHS). Unlike most of you, however, I’m relatively safe in commenting on it without jeopardizing a company’s regulatory standing. In early August, a shooter attacked the Centers for Disease Control (CDC) headquarters in Atlanta, GA, reportedly to “send a message against COVID-19 vaccines.” Police officer David Rose lost his life in responding to the incident.
Perfusion Cell Culture
Allogeneic therapies based on healthy-donor material should help to create scalable processes for “off-the-shelf” drugs, potentially reducing production costs and increasing accessibility, however, developers of allogeneic products also must answer practical questions about where to obtain starting material and how to ensure its quality. This eBook explores solutions for cell sourcing, characterization, and quality control.
From the Editor September 25
Cheryl Scott, Editor in Chief A long with many other sectors of society, the biopharmaceutical industry is adopting artificial intelligence (AI) technology at breakneck speed. But it comes with a significant environmental impact. I’m concerned that companies and other users seem to be ignoring that in favor of the much-touted benefits. AI models require substantial energy for both training and functioning. A generative training cluster consumes many times more energy than typical computations.
BioProcess International | September 2025 Issue 2025 - September | BioProcess International
A long with many other sectors of society, the biopharmaceutical industry is adopting artificial intelligence (AI) technology at breakneck speed. But it comes with a significant environmental impact. I’m concerned that companies and other users seem to be ignoring that in favor of the much-touted benefits. AI models require substantial energy for both training and functioning. A generative training cluster consumes many times more energy than typical computations.
Evolution of Production Strategies
This industry report delivers cutting-edge strategies for antibody–drug conjugate (ADC) manufacturing. We explore the rapidly evolving landscape of ADC production through expert perspectives on balancing yield, stability, and quality in manufacturing.
Viral vector manufacturing capacity outpaces demand through 2031, modeling shows
Rapid advancement of gene therapy has driven a surge in demand for clinical-grade viral vectors. Can the industry meet that demand with manufacturing capacity? The short answer is “Yes – and then some!” As part of the cell and gene therapy track on day three of BPI Europe – held in Hamburg, Germany, this past May – Andrew Harmon of Latham BioPharm Group (part of Sia Partners) presented an approach for modeling biopharmaceutical market demand.
Current Experiences with Process Intensification
Process intensification (PI) represents a paradigm shift in biomanufacturing that offers potentially dramatic improvements in efficiency, productivity, and sustainability. The basic intent is to do more with less: reducing facility footprints, capital expenditures, and operational costs while maintaining or enhancing product quality.
BioProcess International June 2025: Upstream Production Issue 2025 - June
Since the advent of quality by design (QbD) early in this century, risk management has become the core of biopharmaceutical quality-management systems. And we’ve seen both practical benefits from its application and dangers from ignoring possible threats and systemic weaknesses. In the 2020s, the COVID-19 pandemic shined a harsh light of reality on the complacency of many companies, industries, and nations around the world.
Eashwar Rajarman from Novartis wins BPI West 2025 Poster Award
BioProcess International's Editor in Chief, Cheryl Scott, interviews 1st place poster hall winner, Eashwar Rajaraman, principal scientist at Biologics Research Center of Novartis. His team's poster “Iterative design of a DSP Work Package for Multispecifics: Learnings and Adaptations,” summarizes lessons learned in developing a platform-like approach to downstream processing of multispecific molecules.
BioProcess International April 2025: Product Development Issue 2025 - April
Cheryl Scott, Editor in Chief. In publishing, the general rule of thumb is for magazines to undergo a redesign process every five years or so. Longtime BPI subscribers will know that it’s been more than that for us — although our website has been fully refreshed recently. Perhaps that is a sign of the times, and maybe it has something to do with our relatively stable editorial staff and its comfort level with familiar designs.
BioProcess International May 2025: Advanced Therapies Issue 2025 - May
BPI West in San Diego, CA, continues to be my personal favorite conference to attend every year. The location can’t be beat — not least because it’s in zone and saves me from jet lag — but it’s so much more than that. It’s the program, the food, the west-coast vibe, the just-the-right-size crowd . . . and this year, I have to say that the posters in our exhibit hall were the highlight of my week.
BioProcess International March 2025 Issue 2025 - March
In nearly 30 years of working as an editor covering the biopharmaceutical industry, first with BioPharm and later as cofounder of BioProcess International, I’ve copyedited thousands of articles. From business and regulatory discussions to technical reports and reviews, sponsored “advertorial” pieces, and beyond, I’ve seen it all in relation to the biopharmaceutical industry. Some papers, however, have stuck with me more than others, and one in particular comes to mind often lately.
January-February 2025
When I was supposed to be writing this editorial, I instead was watching the funeral of former US president James Earl Carter of Georgia. The eulogy and speeches by family members and politicians were powerful and moving.
A Technology Update for Antibody-Drug Conjugates
The first generation of antibody–drug candidates (ADCs) suffered from instability and systemic drug loss with resulting toxicity. Second-generation ADCs used more potent targeting agents and improved linker chemistries. The third generation introduced site-specific conjugation to produce homogenous ADCs with well-defined drug:antibody ratios (DARs).
Considerations for Developing Assays
Potency. Stability. Product characterization. Bioassays and other analytical methods provide a foundation of information on which biopharmaceutical development and manufacturing are built. Companies working with proteins, gene therapies, and other biological modalities are increasingly interested in taking a platform approach. They would love to have a set of go-to methods and protocols that can be applied across similar products in their portfolios.
November-December 2022 Featured Report
On the Cover: Hepatitis B is an example of a lipid enveloped DNA virus. It is one of the smallest such viruses, with a virion diameter of 42 nm. ( HTTPS://WWW.ALAMY.COM ) Viral safety in the biopharmaceutical industry is both an upstream-production and downstream-processing concern. Companies must take a multipronged approach using orthogonal methods that are validated to prevent viral contamination or to remove it from biologic drug products.
BioProcess International September 2024
With the first half of 2024 now in the rearview mirror, I finally feel like I’m getting my feet under me as editor in chief of BioProcess International. Since the first issue in January 2003, I’ve had the pleasure of helping BPI to establish itself as the leading publication and events brand for the global biopharmaceutical industry. And this September, all the BPI editors will attend our flagship conference and exhibition as part of the Biotech Week Boston festival.
Driving Therapies Forward
Panelists Sam Chuang, Jesse McCool, and Ian Wyllie, with moderator Nicholas Ostrout On Wednesday afternoon, 5 June 2024, contract research organization (CRL) Charles River Laboratories (CRL) held a panel discussion as part of the BPI Theater at the Biotechnology Innovation Organization’s (BIO’s) annual convention in San Diego, CA.
Cell and Gene Therapy Manufacturing Bottlenecks and Challenges
Left to right, panelists Heikki Jouttijärvi, Adam Haskett, David Fontana, and Brad Stewart, with moderator Stephen Orosz. On Tuesday afternoon, 4 June 2024, consultants from BDO USA brought together a panel of leaders from up-and-coming biopharmaceutical companies to examine “make or buy” decision-making for manufacturing of advanced therapies.
From the Editor | BioProcess International
Sep 23 - Sep 26, 2024 Learn from the brightest minds in bioprocessing! The BPI US 2024 scientific agenda includes 200+ of the industry's top scientists to present the latest updates on how to improve efficiencies across all phases of biopharmaceutical development and production. Learn More
New Formats for Novel Biopharmaceuticals
Advances related to drug delivery, formulation, and fill–finish have paralleled drug-modality research in recent years. Perhaps inevitably, the newest formulations and devices bring forth a number of technical and operating challenges in areas such as contamination control, standardization (especially for prefilled syringes), lyophilization, serialization, and management of outsourcing/partnering relationships.
BioProcess International June 2024
As you read this, we’ll be deep into the preparation of our “Platform” issue for publication in August. So now may be your last chance to speak up through our online survey at https://www.surveymonkey.com/r/NDJPPSK . If you haven’t already, I encourage you to drop in there and give us your thoughts now. We want to present the best picture of the biopharmaceutical industry’s current reality in that upcoming issue.
May 2024 Featured Report
As director of biological content at the ATCC, Fang Tian oversees the preparation, authentication, characterization, quality control, and cryopreservation of more than 3,400 accessioned animal cell lines and hybridomas in the nonprofit organization’s cell-biology general collection. She has been with ATCC for 12 years, during which she served as a scientist and head of cell-biology research and development.
Authenticity Matters Cell-Line Development Begins at the Source
As director of biological content at the ATCC, Fang Tian oversees the preparation, authentication, characterization, quality control, and cryopreservation of more than 3,400 accessioned animal cell lines and hybridomas in the nonprofit organization’s cell-biology general collection. She has been with ATCC for 12 years, during which she served as a scientist and head of cell-biology research and development.
Cell-Line Discussions at BPI West 2024
New genetic-engineering techniques, analytical methods, and laboratory technologies are helping to elucidate the inner workings of mammalian and other cells to an extent once never imagined. Cell biologists and process engineers now have an unprecedented ability to refine and control performance in cell cultures. Along with advanced information technologies (ITs), those successes already are changing how biopharmaceutical companies around the world undertake cell-line development (CLD).
September 2023 Featured Report
STOCK.ADOBE.COM Antibody–drug conjugates (ADCs) are straightforward as a concept. When a cytotoxic small-molecule drug is attached to an antibody raised against a specific molecular receptor, it theoretically creates a highly targeted and effective therapy. And the ability to target cells precisely has obvious applications for indications such as cancer. However, in practice, developing and manufacturing ADCs has proven difficult, said Janice M.
BioProcess International May 2024
I’ve been thinking a lot about disruption lately. The modern business-jargon use for the word bothered me the first time I saw it. The term seems to lose most of its negative connotations as users try to express their ideas about radical change but “for the better.” Look up disrupt in a thesaurus, however, and you’ll find that its synonyms are all unfortunate in nature.
BioProcess International October 2024
By the time you read this, I will have served as an award presenter for the first time. Even though it means dressing up and trying not to trip over myself on stage, I’m excited to do this, especially because the award I’ll be presenting at Biotech Week Boston is for sustainability initiatives. As a hiker, camper, gardener, horsewoman, and proud Oregonian, I hold environmental issues close to my heart. And sustainability is a major focus of our company too.
Process Intensification in Biomanufacturing
Process intensification improves manufacturing processes at unit, operational, and functional levels to increase productivity — often reducing environmental footprints as well. Continuous biomanufacturing plays a key role in speeding biopharmaceutical products to market.
April 2024 | BioProcess International
Change continues to abound in BPI’s world, most recently with the launch of our newly redesigned and mobile-optimized website at https://www.bioprocessintl.com . It should look familiar to you but refreshed, and we editors are most pleased with the refined search function. That should make it easier for you to find what you’re looking for in our ever-expanding content archive. The new site is a little faster and better integrated with the BPI events sites now as well.
From the Editor: March 2024
This year’s WCBP Symposium, an annual event presented by our friends at the CASSS organization, was my first business trip as editor in chief. Each January, WCBP brings industry, academic, and regulatory representatives together at the historic Mayflower Hotel in in Washington, DC. The theme for 2024 was “Embracing Revolution,” and it struck a chord with me in this time of great personal change after many years of relative consistency.
Prologue to a Postpandemic Future
The COVID-19 pandemic energized the biopharmaceutical industry, invigorating the vaccines segment in particular. A number of technologies were poised for advancement and made ready (in record time) for implementation as part of the worldwide effort to combat the SARS-CoV-2 virus and its subvariants.
March 2024 Featured Report
The COVID-19 pandemic spurred rapid advancements in the biopharmaceutical sector, particularly in vaccine technology. Previous outbreaks laid groundwork, but COVID-19 accelerated innovation, notably with mRNA vaccines. Lessons learned include the need for robust vaccine production capacity and improved preparedness. Beyond COVID-19, these innovations hold promise for combating various diseases like cancer. Protein-subunit vaccines and glycoconjugate vaccine processing offer alternative approaches.
January-February 2024
With Anne Montgomery’s retirement this past November, I am now the last founder standing on the BPI staff. It began in 2002 as an idea from Brian Caine and Stephanie Schaffer on the business side with Anne and me on the editorial side, and we put out our first issue in January 2003. Now the brand includes conferences in Boston, San Diego, Europe, and Asia; a training academy; an online news outlet; webinars and custom publishing; and of course the publication that you hold in your hands.
March 2024
This year’s WCBP Symposium, an annual event presented by our friends at the CASSS organization, was my first business trip as editor in chief. Each January, WCBP brings industry, academic, and regulatory representatives together at the historic Mayflower Hotel in in Washington, DC. The theme for 2024 was “Embracing Revolution,” and it struck a chord with me in this time of great personal change after many years of relative consistency.
Cybersecurity, Data Integrity, and Value of Biomanufacturing 4.0 - BioProcess International
eBook: Biomanufacturing 4.0 — Cybersecurity, Data Integrity, and Value Regulatory compliance cannot be an afterthought when you apply artificial intelligence, machine learning, and other advanced information technologies to biopharmaceutical development and manufacturing. The authors in this eBook encourage readers to keep product quality (as well as business concerns) in mind, using agile methodologies and good automated manufacturing practices while embracing the bioprocess 4.0 paradigm.
Cybersecurity, Data Integrity, and Value of Biomanufacturing 4.0
Regulatory compliance cannot be an afterthought when you apply artificial intelligence, machine learning, and other advanced information technologies to biopharmaceutical development and manufacturing. The authors in this eBook encourage readers to keep product quality (as well as business concerns) in mind, using agile methodologies and good automated manufacturing practices while embracing the bioprocess 4.0 paradigm.
Introduction: The Next Big Thing Could Be Disruptive - BioProcess International
Introduction: The Next Big Thing Could Be Disruptive It’s no secret that mammalian cell culture is the predominant production system in the biopharmaceutical industry. Microbial expression has been around longer, not least because of the early influence of the brewing industry. But once Chinese hamster ovary (CHO) and other animal cells could be cultured at scale with reliable results, that approach soon “disrupted the paradigm,” as our friends in marketing like to say.
Developers Work To Refine Platforms for the Best Results - BioProcess International
On the cover: an artist’s rendering of antibody molecules with linker–toxin payloads attached. HTTPS://STOCK.ADOBE.COM Antibody-conjugate technologies have been pushed out of the limelight somewhat in recent years by mRNA/oligonucleotides and cell/gene therapies.
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