Manufacturing

eBook: Working Together Is Key to Bioprocess Sustainability

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Sustainability initiatives are launching across the biopharmaceutical industry as companies begin to scrutinize their environmental impacts as part of the growing environmental, social, and governance (ESG) movement in business. Achieving ambitious sustainability goals will require organizations to evaluate their raw materials, production processes, product packaging, operations, and supply and distribution chains — and such work will entail monumental effort. As this special eBook presentation from the editors of BioProcess International and BioProcess Insider demonstrates, bioprocess sustainability necessitates collaboration across the…

Addressing Gaps in US Biomanufacturing Capacity

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In December 2022, the President’s Council of Advisors on Science and Technology (PCAST) submitted a report to Joe Biden about biomanufacturing in the United States. In a letter prefacing the report, the council cochairs noted that the bioeconomy is “poised for enormous growth over the coming decades” (1). On 22 March 2023, the White House Office of Science and Technology Policy responded with a set of five initiatives to help realize the potential of the nation’s bioeconomy. The broad goal…

Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems

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Demand for biopharmaceuticals is growing rapidly as new products and manufacturing technologies arise. For example, such approaches as immunooncotherapy and oncolytic viral therapy are now entering one of the fastest growing markets in medicine — cancer treatment. This market “should grow from [US]$177.4 billion in 2021 to $313.7 billion by 2026, at a compound annual growth rate (CAGR) of 12.1%” (1). Both preclinical and final biomanufacturing increasingly incorporate single-use (SU) components, including hardware and systems for containment and connectivity. Solutions…

Change Is Difficult, But It Is Inevitable: The Value of Integrated Project Delivery to Biomanufacturing-Facility Construction

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Agility, speed, and disruptiveness are now the “table stakes” in a world where the old rules governing biopharmaceutical manufacturing are being rewritten — in no small part by the COVID-19 pandemic and a new emphasis on lean project-delivery principles. All along the pharmaceutical value chain, companies, governments, and scientists worked at unprecedented speeds to mitigate SARS-CoV-2 outbreaks. Collaboration and constant communication among clients, trade partners, and vendors were critical at each step, from research and development (R&D) through commercial-scale production…

Vaccine Research and Development Infrastructure in the European Union: Establishing Support Through Integration

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Developing novel medicinal products involves many processes and requires a number of different technologies and areas of expertise. Although large pharmaceutical companies can support in-house development and fill gaps by hiring contract development and manufacturing organizations (CDMOs), the cost, complexity, and scope of development are prohibitive for most academic or small- and medium-sized enterprises (SMEs). Such difficulties are amplified for vaccine developers, especially those working to treat vulnerable populations in low- and middle-income countries where profit potential is limited. A…

Digital Transformation in Biopharmaceutical Operations

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With digital innovations revolutionizing consumer-facing products such as medical devices, questions are arising about whether the biopharmaceutical and broader pharmaceutical industries are embracing digital transformation to drive process improvements and meet changing product demands. Below, Fausto Artico (global head and product director of innovation and data science at GSK) shares his insights about digitalization among pharmaceutical companies that are developing protein-based biologics, vaccines, and advanced therapies. Artico has driven several of GSK’s digitalization initiatives, including work with artificial intelligence (AI)…

Cleaning Validation Acceptance Limits for Biological Process Residues: Part 1 — Acceptable Exposure of Degraded Proteins Based on Reference Immunogens

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Over the past decade, human therapeutic proteins (HTPs) have become far more potent, and consequently, their acceptable exposures have decreased substantially. That has led to commensurately lower acceptance limits for biological process residues. Simultaneously, host-cell and other protein concentrations have increased considerably, thereby making process equipment potentially more difficult to clean. These trends have made biopharmaceutical cleaning validation more challenging. For example, the acceptance limits for many HTPs — based on acceptable exposures of active proteins — are on the…

Leveraging Material-Binding Recombinant Proteins: A Novel Approach to Tissue Regeneration

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In March 2023, I took the opportunity to speak with Luis Alvarez about the founding of Theradaptive. The company specializes in engineering recombinant proteins, with an initial focus on developing therapeutics for regeneration of soft, vascular, and bone tissue. “Theradaptive grew out of my thinking about combat injuries,” Alvarez told me. Before earning a doctoral degree in biomedical engineering from the Massachusetts Institute of Technology and working as cofounding deputy director of the US Department of Defense’s regenerative medicine program,…

April 20, 2023

Overcoming the Digital Divide: Leveraging Intelligent Automation and Informatics Expertise

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Shifting to a digital regulatory environment is forcing pharmaceutical companies to confront knowledge gaps across key research and development (R&D) functions. As health authorities streamline information exchange through data standardization, the separation between regulatory operations and other functions within the pharmaceutical industry begins to blur. By advancing implementation of ISO identification of medicinal product (IDMP) standards, companies are improving interoperability and information sharing among key clinical, pharmacovigilance, quality, manufacturing, and supply-chain–logistics teams. However, a company’s important regulatory and strategic planning…

April 20, 2023

Large-Scale AAV Production: Advantages of an Insect-Cell Baculovirus Expression Vector Platform

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Adenoassociated viruses (AAVs) have been the center of intensive research since their fortuitous (incidental) discovery in 1965 as a contaminant in a simian adenovirus preparation (1). Initial scientific interest primarily focused on understanding the fundamental biology of this virus type, but later it was harnessed to serve as a genetic vector for use in treating or even curing certain genetic diseases (2). Many distinct characteristics make AAVs a versatile tool for development of clinical candidates, exemplified currently by more than…

April 20, 2023