Manufacturing

Principles of Sustainable Development: Establishing a Successful Framework To Drive Change

Addressing sustainability can seem insurmountable for any business. Doing so requires endorsement from senior leadership and engagement from an entire organization. To ingrain sustainability into a company’s everyday activities, company leaders must enact strategies that are easy to implement, that produce results quickly, and that will promote long-term goals. Embracing a cycle of continuous improvement is crucial because today’s challenges and innovations can shape the norms of tomorrow, when new challenges inevitably will emerge. Environmental and social governance lies at…

Designing Single-Use Facilities for Biomanufacturing Expansion

Minimizing a facility footprint while maximizing manufacturing capacity is essential to staying agile, productive, and cost-effective — all of which are key elements to competing in a dynamic business landscape. To achieve such efficiency at commercial scale, bioprocessing facility design should be tailored to each organization’s specific needs. During scale-up, tailor-designed facility planning is critical to streamlined manufacturing of high-quality products. The size and layout of a space can otherwise become a limiting factor for long-term productivity, revenue, profit, and…

Addressing Gaps in US Biomanufacturing Capacity

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

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

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

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

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

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

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,…

Overcoming the Digital Divide: Leveraging Intelligent Automation and Informatics Expertise

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…