eBooks

eBook: Bioreactor Sensors —
Inside the Dynamics of Cell Culture

Cell culture monitoring can fall into something like a “black box” conundrum. Efforts to measure key parameters such as pH, glucose, and even cell density require sampling and removal of the contents from a bioreactor. But that procedure can expose both a process and an operator to contamination risks. Emerging bioreactor sensors are designed to address some of those challenges, but the rapid adoption of single-use technologies and the rise of perfusion cell culture have presented obstacles to their implementation.…

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…

eBook: Buffers — Navigating New Demands on Downstream Raw Materials

Bioreactor titers for monoclonal antibody (MAb) processes have increased significantly since the dawn of the biopharmaceutical industry, yet such gains have instigated bottlenecks for critical high-volume raw materials used in downstream processing, such as buffer solutions. As downstream purification is required for most, if not all, biopharmaceutical products, buffers and their preparation are topics that concern nearly every drug company. But those topics rarely receive direct attention. This BPI eBook explores what factors prompted the current buffer bottleneck and what…

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…

eBook: Formulation, Fill–Finish — Biopharmaceutical Drug-Product Trends and Technologies

As with many other aspects of biopharmaceutical development, evolving technologies are transforming drug-product development and manufacturing. In a November 2020 report on the Informa Connect “Drug Delivery Partnerships” meeting, BPI senior technical editor Cheryl Scott reviewed how new delivery-device technologies are bringing together companies with disparate expertise to serve patients with chronic conditions better than ever before. The ever-increasing capabilities of electronics and information technology (IT) not only are enabling development of “smart” delivery devices, but also improving the potential…

eBook: Biomarkers — Improving Clinical Studies to Enhance Commercial Success for Biologics

The biopharmaceutical industry continues to invest heavily in technologies for identification of predictive biomarkers. Drug developers want not only to find quantitative evidence that their therapies will work as designed, but also to anticipate which patient populations will respond positively to those regimens. Doing that could streamline clinical trials, accelerate approvals, and ultimately improve patient outcomes. Advances in next-generation sequencing and increases in computational capability now are facilitating biomarker inquiries, especially in the realm of immunooncology. However, predictive biomarkers remain…

eBook: Ion-Exchange Chromatography for Modern Biopharmaceutical Purification

Understanding the functionalities of chromatography resins can improve the product yield and purity in a biotherapeutic purification workflow. Ion-exchange (IEX) chromatography separates biomolecules on the basis of charge. For several reasons, it is the most widely used separation tool for purification of biopharmaceutical products. IEX is a well-characterized purification method with high binding capacity and flexible selectivity. It also works with mild operating conditions that help to preserve the biological activity of a biopharmaceutical drug substance. That versatility enables several…

eBook: Drug Delivery —
Partnerships Are Key As Medical and Digital Worlds Converge

Drug delivery is advancing into a digital future. Information technology is changing aspects of every operation in the biopharmaceutical industry. Meanwhile, machine learning and cloud computing are not only finding their way into drug development, manufacturing, and distribution, but also into drug-product delivery devices themselves. As a result, many biopharmaceutical companies are seeking medical device expertise through strategic alliances and contract services. New delivery devices can help big companies extend patent protection on established marketed products, for example, and provide…

eBook: Downstream Processing — An Overview of MAb Purification Methods

The downstream harvest, clarification, and purification operations of biologics are essential steps to ensure drug product safety. However, these process steps can be problematic for complex biologics. Compared with processes for traditional small-molecule pharmaceuticals, downstream methods for monoclonal antibodies (MAbs) have higher risks of contamination. Thus, different centrifugation, filtration, chromatography technology and viral clearance/inactivation strategies must be applied to remove dead cells, host-cell proteins, viruses, and other contaminants. Several factors must be considered to determine which methods and technologies are…

eBook: Mixed-Mode Chromatography for Purification of Biopharmaceuticals

Mixed-mode chromatography offers several advantages in downstream processing of biotherapeutics. Mixed-mode chromatography resins use ligands that are capable of at least two modes of interaction with solutes such as hydrophobic, ion exchange, and metal affinity. The interactions between stationary and mobile phases that result from those combinations enhance chromatographic selectivity, facilitating separation efficiencies that are not possible using other chromatography media. As this eBook illustrates, the multimodal approach can save developers time and money by enabling robust purification of biopharmaceuticals…