eBooks

eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs

Biopharmaceutical industry training is imperative not only to ensure patient safety, but also to develop a skilled workforce that can support successful businesses. Current good manufacturing practice (CGMP) skills and behaviors are needed so that products being developed, manufactured, and delivered are compliant and within specifications. Individuals who fulfill roles within development, manufacturing, and delivery processes need some level of education to develop all the necessary skills and behaviors. Adult earners have unique needs and requirements that must be incorporated…

eBook: A Dynamic Control Strategy for Downstream Continuous Bioprocessing

Continuous processes can have many sources of variability. In downstream unit operations, changes can arise because of feed material variability, resin fouling in chromatography columns, column compression or failure, membrane fouling, depth-filter clogging, and so on. The US Food and Drug Administration’s guideline for continued process verification encourages biomanufacturers to monitor their processes and keep them under a steady state of control. One way to achieve that in continuous downstream processes is to implement a dynamic control system that adapts…

eBook: Biopharmaceutical Outsourcing — Capacities, Companies, and Current Trends

Although many biopharmaceutical companies leverage in-house capabilities to produce their therapies, contract manufacturing partners represent a significant part of the biologics industry. Recent capacity investments, facility expansions, and mergers and acquisitions (M&A) activity even suggest that third-party biologics production is gaining traction. In this eBook, BioProcess Insider’s founding editor, Dan Stanton, takes the pulse of today’s outsourcing sector. First, he speaks with Dawn Ecker (director of bioTRAK database services at BDO) to establish what kinds of companies are amassing mammalian…

eBook: Intensifying Processes for Monoclonal Antibodies

The commercial manufacturing success of monoclonal antibodies (MAbs) has become a touchstone of the biopharmaceutical industry. MAbs are so well established that they often are referred to as “traditional” biologics, and well-known MAb processing methods have become a model for processing of other “advanced” or “emerging” therapies. But MAb processing continues to advance as biomanufacturers seek ways to improve efficiencies, lower costs, and (most recently) increase sustainability of facilities. Drug makers are particularly interested in strategies for MAb process intensification.…

eBook: Potency Bioassays — Development, Trending, Transfer, and Automation

Bioassay development is a complex process that must be undertaken with great rigor and attention to detail. Potency testing experts use a range of methods including cell-based and binding assays. Consistency and reliability of results over time are paramount. Well-developed and -characterized methods are the end result of much phase-appropriate development work that goes on in parallel with bioprocess and biotherapeutic product development. This eBook begins with BPI senior technical editor Cheryl Scott’s report from the Biopharmaceutical Emerging Best Practices…

eBook: Sensors — Process Analytics for Modern Biopharmaceutical Workflows

To achieve quality by design in biopharmaceutical production, manufacturers need tools that can ensure the stability of critical process parameters (CPPs) and other performance indicators related to product critical quality attributes (CQAs). Over the past couple of decades, sophisticated process analytical technologies (PATs) have emerged to address such needs. Offerings are now abounding for single-purpose sensors that measure temperature, pressure, pH, glucose, protein concentration, or dissolved oxygen. New in-line formats are enabling such instruments to provide data in real time,…

eBook: Gene Therapies —
Developers Slowly Emerge from a Pandemic

This eBook gauges shifting expectations for the gene therapy industry amid the COVID-related uncertainties and clinical setbacks of the past couple years. BioProcess Insider founding editor Dan Stanton reports on the January 2022 Phacilitate Advanced Therapies Week event, specifically a standing presentation on the 10 most important industry drivers from the past year. Since 2017, advancements in gene therapies have featured prominently in these presentations. In 2021, gene therapies again made the list, but this time for more troubling reasons,…

eBook: Antibody–Drug Conjugates —
A New Generation of Approaches Is Changing the Game

Combining large proteins with linkers and cytotoxins, antibody–drug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody — as well as ensuring their proper attachment and biophysics — all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

eBook: Diagnostics — Developing Rapid and Accessible Testing Solutions

The COVID-19 pandemic has brought myriad economic disruptions, social complications, and public-health calamities to the world. They have understandably overshadowed the silver lining of boosting biomedical science and technology in the realms of infectious disease, oncology, and more. But alongside the much-publicized commercial debut of novel vaccine technologies have come promising advances in medical diagnostics. In this eBook, BPI’s senior technical editor brings together perspectives from industry, academia, and expert organizations to highlight some of the latest diagnostic methods and…

eBook: Creating CMC Strategies for Pandemics and Beyond — Perspectives on the Impact of the COVID-19 Pandemic

The COVID-19 novel coronavirus pandemic has highlighted the biopharmaceutical industry’s need to create and implement chemistry, manufacturing, and controls (CMC) strategies that can expedite drug development during times of crisis. This bold topic was the premise of the 2021 CASSS Well-Characterized Biotechnology Products (WCBP) forum titled “Special Edition: Creating CMC Strategies for Pandemics and Beyond.” Held virtually on 25–28 January and 1–4 February 2021, the eight-day event addressed manifold considerations for SARS-CoV-2 virus prevention, diagnosis, and treatment. Five hundred attendees…