eBooks

eBook: ADC Advances — Leveraging Classical and Emerging Technologies

Between 2000 and 2019, the US Food and Drug Administration (FDA) approved only four antibody–drug conjugate (ADC) products for commercial distribution. Between then and 2024, however, the number of marketed ADC products has swelled to 13, and clinical studies are underway for more than 100 candidates that address nearly 40 indications, mostly in oncology. Recent successes might seem to have come suddenly considering the previous dearth of approvals. But drug companies in the ADC space have worked steadily both to…

eBook: Flexible Facilities — Exploring Hybrid Biomanufacturing Strategies

Flexibility is a primary consideration in today’s biopharmaceutical industry. Drug companies must develop and ultimately manufacture increasing numbers of therapies, many of which treat indications with smaller patient populations than those addressed by “blockbuster” drugs. For such reasons, facilities outfitted with fixed, large-volume stainless-steel equipment are becoming less conducive to meeting current and projected business goals. Single-use technologies would seem to provide added flexibility, although the goal of implementing fully single-use operations remains impractical for many facilities. Hence, companies are…

eBook: Strengthening Europe’s Cell and Gene Therapy Sector — Safeguarding the Medicines of the Future

Incorporating expertise taken from both Informa’s Biotech Week Boston (BWB) 2023 and Phacilitate’s Advanced Therapies Europe (ATE), this eBook examines the cell and gene therapy (CGT) space in Europe, focusing specifically on the challenges surrounding clinical trials and exploring how the region can fix “this bump in the road” to safeguard the medicines of the future. First, Millie Nelson points to increasing caution as key industry players have expressed the need for Europe to reform its pharmaceutical legislation got corporate investment…

eBook: Vaccines — Expanding Access Through Innovation and Collaboration

The rapid global response to the COVID-19 pandemic showed how remarkably fast vaccine development can be with a coordinated effort from biopharmaceutical companies, government organizations, regulatory agencies, and public institutions. Although some of the world’s most prolific diseases are more complex than COVID-19 coronavirus, growing infrastructural and financial support are enabling scientists to make breakthroughs in diseases that seemed insurmountable only a decade ago in underserved regions around the world. And with accelerated discover times thanks to advanced technologis such…

eBook: The Key Role of Analytical Methods in Technology Transfer

Assay development doesn’t end with a validated analytical method. Changes are made as a biopharmaceutical product continues through development. Often that progress includes transfer from the original laboratory to another. Whether a project is outsourced or scaled up in house, analytical methods such as bioassays must be transferred to new laboratories, with different personnel and often different equipment setups. Making sure they can repeat that validated method with equivalent results is key to both regulatory compliance and product safety and…

eBook: Aseptic Processing — Reflections from the 2023 ISPE Aseptic Conference

Biopharmaceutical products must be sterile. Protein biologics and now advanced-therapy medicinal products (ATMPs) usually are administered in ways that bypass patients’ natural immune defenses. Therefore, such drugs increase risks for introducing contamination to their recipients. Because terminal sterilization can destroy biological products, aseptic manufacturing is the primary means for ensuring drug-product sterility. However, aseptic processing involves many more variables than does terminal sterilization, making it imperative for drug manufacturers to keep abreast of emerging techniques for aseptic processing and evolving…

eBook: Outsourcing — Triumphs and Turmoil in Establishing Biologics CDMOs

Outsourced development and manufacturing once were all but out of the question in the biopharmaceutical industry. Regulatory changes, technical and scientific advances, and an increasingly global market have transformed a once-risky option into a common business strategy. This eBook brings a historical perspective and valuable advice from lessons learned through decades of experience. Well-known industry advocate and executive consultant Roger Lias highlights the challenges and keys to success on the service-provider side as the economic environment invites budding entrepreneurs to…

eBook: Viral Vectors — Progress Toward Production Platforms

After decades of research and development (R&D) and despite more than a few clinical setbacks, viral-vector gene therapies finally are making headway into the marketplace. However, cost considerations still reverberate around the biopharmaceutical industry. Scientists recognize that nonoptimal manufacturing is implicated in the high prices for gene-therapy products. For instance, adenoassociated virus (AAV) and other such gene-delivery systems are produced at much lower scales than are monoclonal antibodies (MAbs) and other recombinant proteins — understandably so given the size and…

eBook: Oligos and mRNA — Manufacturing in Facilities Around the World

Three years ago, mRNA biotechnology was poised to provide just what the world needed to fight SARS-CoV-2. Researchers already had been working to develop nucleotide therapies for cancers and infectious disease, and the pandemic gave companies an immediate proving ground for speeding up development and demonstrating what such technology could accomplish. Capitalizing on the resulting success, developers of mRNA and related oligonucleotides now are looking to the future and addressing a number of manufacturing challenges to ensure widespread access to…

eBook: Intensified BioProcesses — Uniting Productivity and Sustainability

Biopharmaceutical companies gradually are exploring options for process intensification (PI) and continuous manufacturing. Such strategies are known to increase process economics and decrease equipment footprints, both of which help to reduce cost of goods, capital expenditure, and operational costs. But as this eBook shows, most companies have yet to consider another critical driver for adopting intensified bioprocesses: sustainability. Recent studies into the environmental impacts of monoclonal antibody (MAb) production processes have underscored the water intensity of biomanufacturing. In this eBook,…