Manufacturing

eBook: Cancer Vaccines ⁠— Innovation Fuels an Immunotherapy Renaissance

Despite early successes a decade ago, cancer vaccines designed to deliver peptides or proteins — or nucleic acids encoding those antigens — generally have fizzled out since then. As a result, cancer vaccine development and the field of immunotherapy lost some traction overall. But as freelance contributor Jim Kling describes in this eBook, new innovations in product design, testing, and manufacturing are fueling a renaissance in cancer vaccine development. From checkpoint inhibitors to neoantigens, immune regulators, and beyond, companies are…

eBook: Formulation, Fill, Finish ⁠— Biopharmaceutical Drug Products for a Modern Age

Biopharmaceutical drugs are increasing in sophistication, requiring technological advancements to solve related challenges. The contributors to this BPI eBook highlight drug-product formulation concerns and collaborative efforts toward solving the fill–finish conundrum. First, the BioPhorum’s Scott Ewan describes a holistic approach to container–closure integrity and the organization’s work toward developing and expanding upon that approach. Ewan explores how advancing analytical technologies, risk management, and quality by design (QbD) are changing the strategies related to container–closure integrity, which remains a significant aspect…

Finding Efficiencies to Accelerate Biopharmaceutical Development

An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those parameters necessarily deemphasizes one or both of the others. For most of the biopharmaceutical industry’s early years, companies operated on that assumption. Many organizations saw speed as the weakest link that could be more or less ignored; others had money to burn. The smartest…

Biosimilars Pipeline and Market Trends

Most biopharmaceutical industry experts now consider biosimilars to be mainstream products, indicating that the field has progressed immensely over the past 10 years. Nevertheless, when comparing approvals and commercial offerings across the globe between 2013 and 2020, it becomes clear that some regions welcome these therapies more than others do. Western European biosimilars markets continue to be kind to these drugs’ production, distribution, and coverage; and companies headquartered in Asia and the Pacific Rim increasingly are getting involved in biosimilars…

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

Applications of Disposable Technologies for Upstream Bioprocessing

Over the past 10 years, a number of developments in disposable (limited use) and single-use technologies (SUTs) have been made for different bioprocess operations. Until recent years, much of the industry’s process equipment was sterilized using thermal methods such as autoclaving. Most equipment was reusable and required cleaning and sterilization before use. Such processes required validation and expensive and time-consuming resources. Production facilities relied on hard-piped, inflexible equipment such as large stainless-steel bioreactors and holding tanks. However, advanced SUTs now…

Viral-Vectored Gene Therapies: Harnessing Their Potential Through Scalable, Reproducible Manufacturing Processes

We might not associate the jazz queen Ella Fitzgerald with 21st-century gene-based therapies, but the First Lady of Song was on to something back in 1939 when she sang “’T’Ain’t What You Do (It’s the Way That You Do It).” Although demonstrating the safety and efficacy of gene-based therapies in rigorous clinical trials is essential for gaining product approval from regulators, doing the bare minimum is insufficient. The way that such products are produced also matters. Manufacturing processes and protocols…

Reduce Downstream Processing Costs for MAbs By Switching to a Two-Step Platform

Downstream processing operations make up to 80% of the total costs for processing biotherapeutics. Given the current drive to reduce downstream costs, chromatographers and process engineers will need to streamline processes. Herein, we describe the benefits offered by using Tosoh’s two-step process for purifying monoclonal antibodies (MAbs) and compare that method with the standard industrial process. By combining high-performance protein A capture and a single polishing step on salt-tolerant anion-exchange resin, Tosoh’s approach can reduce downstream costs by 45% and…

Process Intensification of Viral-Based Vaccines: Where Are the Bottlenecks?

In the current coronavirus pandemic, the ability to scale up and produce viral-based vaccines (attenuated viral vaccines, inactivated viral vaccines, and viral vector vaccines) quickly and in large quantities has never before been more relevant. For viral-based vaccines that can be produced by adherent or suspension cell culture, process intensification — in which cell culture, for example, is optimized to produce higher viral titers using the same process equipment — offers a strategy to produce larger numbers of doses in…

Ask the Expert: Emerging Trends in Drug Assembly and Packaging

Thomas Gabriel (director of strategy and business development at Fujifilm Diosynth Biotechnologies, FDB) emphasized patient agency in his 15 April 2020 “Ask the Expert” presentation on innovations in finished-goods solutions. Facilitating self-administration significantly benefits patients with chronic conditions, and new delivery technologies are making drug products increasingly easy to handle and with increasingly accurate dosing. Gabriel explored how single-use autoinjectors and prefilled syringes, needle shields, on-body delivery systems, and digital monitors are improving drug-delivery safety and efficacy while enabling patients…