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Rapid Screening of Bioavailability: Enhancing Technologies to Accelerate Time to Clinic

Jesus Rosales, senior scientist in oral formulation development, Catalent. Rosales highlighted efforts to accelerate small-molecule products into clinical development. His company uses rapid formulation prototyping and both in silico and in vitro tools for technology selection. Early phase development is a tortuous path for every drug type, from identifying and validating targets and leads to optimization of drug products. Many options are available for oral solid-dose products: basic powder forms that are reconstituted in a clinic, capsules containing only the…

Improvements and Innovations in Lentiviral Manufacture

Ryan Cawood, chief scientific officer, WuXi Advanced Therapies. In this presentation, Cawood focused on transient lentiviral manufacturing, plasmid creation and analysis, and stable cell-line development for continuous lentiviral production. The work is performed at WuXi Advanced Therapies facilities in Philadelphia, PA, based on methods developed at the company’s research institute in Oxford, UK. The latter site was Oxgene, a company that Cawood founded and that was acquired by WuXi Advanced Therapies in 2021. The WuXi Advanced Therapies transient lentiviral manufacturing…

Advancing Biomanufacturing Capabilities with a Next-Generation Single-Use Solution

Charles Heise, senior staff scientist in bioprocessing strategy and development group, Fujifilm Diosynth Biotechnologies. Heise presented work Fujifilm Diosynth Biotechnologies has done to debottleneck downstream processes for continuous operations and high-titer product batches. He highlighted the benefits of automation and data management, closed processing, and advanced buffer management — all together in the SymphonX system. A disposable flow path provides buffer-management capability through standard software for “multifunctional” operations. The company wanted one “rig” to perform all the necessary downstream functions,…

Using Innovation and Investments to Advance Nanoparticle Formulations

Tara Lorenz, director of commercial development, Emergent BioSolutions. Lorenz presented two case studies: one demonstrating technology transfer of a liposomal immunotherapy using extrusion technology and the other describing process performance qualification (PPQ) of a lipid nanoparticle (LNP) formulation for mRNA delivery. The first example product is a self-assembling, protein-based nanoparticle vaccine that’s now in phase 1 clinical testing. The second project involves peptide–mRNA nanoparticle therapeutics against specific cancer targets. Emergent operates three centers of excellence for nanoparticle-based formulations, each with…

Crossing the Finish Line: Preparing for and Passing a Preapproval Inspection

Ray Marzouk, vice president of quality, Avid Bioservices. Since Avid’s first commercial approval in 2005, the company has been inspected multiple times by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Brazilian Health Regulatory Agency, and Health Canada. Avid makes drug substance for products that are approved and marketed in more than 90 countries. The company has succeeded in eight preapproval inspections (PAIs), the most recent five of which had no 483 observations. PAIs differ…

Transforming the Biopharmaceutical Development Roadmap

Biopharmaceutical analytical methods have improved significantly since the early 1990s. Techniques and fundamental mechanisms largely have remained the same, but modern analytical tools are delivering better insights into drug-product characteristics thanks to improved reagent quality, method intensification, and automation. Harmonized regulations and the revolutionized role of contract development and manufacturing organizations (CDMOs) also continue to support bioprocess transformations. Improved Analytics and Standardized Single-Use Equipment Today’s analytical methods provide high resolutions and deliver reliable results quickly. For example, sodium dodecyl sulfate–polyacrylamide…

Reflections on the Evolution of Biopharmaceutical Manufacturing: A Virtual Roundtable with Scientists from Sartorius

As a trusted partner in the life-sciences industry, Sartorius has contributed significantly to the evolution of biopharmaceutical manufacturing. To reflect on the rich history of the industry, we arranged a virtual roundtable. Based on shared questions, we corresponded about what we considered to be the most important scientific, technological, and operational developments in the past 20 years of bioprocessing. We also reflected on the emergence of new modalities and how such products are likely to shape the future of the…

Reflections on 20 Years: A Conversation with Yposkesi’s Chief Technical Officer

Brian Mullan joined Yposkesi, an SK pharmteco company, as its chief technical officer in 2020. With over 20 years of experience, he has held leadership roles in late-phase process development, product launch, and commercial supply for large pharmaceutical companies making therapeutic monoclonal antibodies (MAbs). In eight years at Novartis, Mullan held posts as head of manufacturing science and technology and as a global technical project leader. From 2008 to 2012, he was process technology-transfer lead at Eli Lilly and Company.…

Global Excellence in Biomanufacturing: Fueled by 150 Years of Creating Value Sustainably

Rentschler Biopharma began its role as a contract development and manufacturing organization (CDMO) for biopharmaceuticals in 1997. Founded in 1872 as a pharmacy in Laupheim, Germany, the company transitioned to pharmaceutical manufacturing, then branched out into biotechnology, and ultimately channeled its expertise and experience into becoming a global CDMO. Our success over the past 150 years has been based on a strong foundation of creating value sustainably, and that has paved the way for further advancement and success. As a…

The Coevolution of the Single-Use and Biopharmaceutical Industries: Company and Industry Reflections from Colder Products Company (CPC)

Single-use technology (SUT), specifically its evolution from clinical applications to commercial production, has made a remarkable impact on bioprocessing. SUT flexibility and sterility have helped to build a strong foundation for manufacturers to initiate production of many different drugs quickly and cost-effectively, including vaccines and cell and gene therapies (CGTs). Single-use systems make it economically feasible to manufacture therapies for diseases that affect relatively small patient populations — the kinds of numbers that might not justify an investment in a…