Welcome to BPI’s 15th-anniversary celebration and report of the state of the biopharmaceutical industry. We endeavored to lay out not only where things are in the biopharmaceutical manufacturing industry, but a vision for where they should go. We began our journey toward completing that mission with a self-selected survey of our readership. About 300 respondents helped us identify trends and advances that have changed and are changing the face of the 21st-century biomanufacturing industry.
Chapter 1 — The Bioexecutive Perspective:
Business Strategies for a Rapidly Maturing Industry
The biopharmaceutical industry currently enjoys an expanding world of opportunity and has come up with many business models to serve global healthcare. Authors, reader-survey respondents, and editorial advisors contributed to examine trends in investment and finance, marketing/pricing and business development, outsourcing and legal issues, recruitment and training, partnering, product portfolios, and more.
Chapter 2 — The Laboratory Manager’s Perspective:
Ensuring Efficiency, Data Integrity, and Compliance
Bioprocess laboratories have taken advantage of state-of-the-art innovations in equipment and automated systems to operate effectively. However, some challenges remain in balancing efficiency and modern approaches with costs. This article highlights advances in laboratory equipment such as automation and digital technology; lab-scale processes such as microbioreactors and single-use systems; design of experiment (DoE) approaches; strategies for managing costs, timelines, and workflows; compliance with regulatory requirements, and robust lean (Six Sigma) practices in bioprocess laboratories.
Chapter 3 — The Project Manager’s Perspective:
Managing Timelines, Budgets, and Milestones in Multidisciplinary Teams
Today’s project managers have many more tools than in previous years for monitoring the progress of, and communicating with their multidisciplinary teams. More biopharmaceutical companies are embracing the need for trained project managers than they were even a decade ago. This chapter discusses the ongoing progress and gaps that remain, not the least of which is the need for improved training and access to the skilled managers and technicians of the future.
Chapter 4 — The R&D Perspective:
Mapping New Pathways from Discovery to Development
Biopharmaceutical innovation is alive and well. An ever-widening array of product modalities is taking the industry beyond proteins to genes, cells, and tissues — beyond monoclonal antibodies to fragments, bispecifics, and antibody–drug conjugates — beyond live/attenuated vaccines to recombinant proteins, nucleic acids, and immunotherapies. Trends in regenerative and personalized medicine, fusion proteins, developability assessments, exosomes, and more are considered.
Chapter 5 — The Regulatory Affairs Perspective:
Addressing Compliance in a Changing Industry
Bioprocessing remains a highly stringent industry, and full compliance is vital to ensuring the high quality, safety, and efficacy of biotherapies. This article will review approaches to CGMP training, addressing CMC issues, implementation of the FDA’s risk-based approach, regulatory “flexibility” by using QbD and PAT-driven processes, INDs/BLA submissions, digital technologies and electronic filings, process validation guidelines, the FDA’s biosimilars pathway, and the progress in the approval for ADCs, bispecific antibodies, and other emerging therapies.
Chapter 6 — The Supply-Chain Management Perspective:
Managing Risks and Guarding Against Disruption
Biopharmaceutical packaging and shipping practices also have adapted to accommodate the risk-based quality-management guidelines that have taken hold of the industry. This chapter looks at the evolution of current approaches to logistics and cold-chain management drawing from survey responses and from a selection of BPI authors.
Chapter 7 — The Process Development Perspective:
Implementing Tools for Optimization
Biomanufacturers strive toward efficient means of accelerating process development timelines and reducing development costs. This article provides an overview of the implementation of process analytical technologies (PAT), quality by design (QbD), and data-driven processing; the effective use of design of experiments (DoE); the widespread use of single-use systems and high-throughput processes; strategies for accelerating process workflows; outsourcing process development activities; and process monitoring and control tools.
Chapter 8 — The Manufacturing Perspective:
Current Approaches to Bioprocess Intensification
The advances in biopharmaceutical production and manufacturing over the past decade or more form a complex array of interdisciplinary connections, new analytical technologies, emerging product/therapeutic modalities, and the influx of a new generation of bioprocessors who are stepping into legacy processes. In this chapter industry participants provide a snapshot of progress and their visions of the manufacturing processes of the future.
Chapter 9 — The Technology Transfer Perspective:
Modern Approaches and Challenges
Whether technology transfer involves site-to-site transitions, in-house scale up, contractual services, or any combination of these, the goal is to have the new process produce results that are as close as possible as the original. This article highlights different technology transfer models; risk management tools; due diligence; PAT and process understanding; and 21 CFR part 11 compliance along with other regulations.
Chapter 10 — The Engineer’s Perspective:
Transforming Science into Technology
Engineering is the core of innovation. Authors, reader-survey respondents, and editorial advisors will help us examine trends across the range of engineering disciplines in: single-use technology, tissue engineering, modeling and design, combination products and delivery devices, environmental sustainability, and more.
Chapter 11 — The Analyst’s Perspective:
Ensuring and Controlling Quality of Well-Characterized Biologics
Analytical methods are the foundation of all biopharmaceuticals: from product discovery, characterization, formulation, and testing to process development and optimization, raw materials analysis and equipment qualification, quality assurance and control. Industry contributors contributed to explore trends in comparability testing, multivariate analysis, automation, statistics, validation, and more.