Off Script: A Pharma Manufacturing Podcast

In biomanufacturing, recovering intracellular bioproducts after fermentation can be a costly and energy-intensive process. To address this challenge, researchers are developing new approaches to reduce energy consumption and waste during downstream processing, one of the largest hidden costs in biomanufacturing. This episode of Off Script looks at a BioMADE-funded project — a collaboration between...

Tighter funding conditions are putting greater pressure on emerging biotech to reach key development milestones quickly while managing limited budgets. That environment is also changing what sponsors expect from their manufacturing partners, driving demand for development models that emphasize speed, predictability, and cost certainty. In this episode of Off Script, we spoke with Sanjay Konagurthu...

Despite ongoing geopolitical and regulatory pressures, life sciences manufacturers continue to invest in their product pipelines while also being more deliberate about long-term portfolio decisions. As interest in peptides, ADCs, and cell and gene therapies continues, manufacturers are weighing the complexity and costs of developing these medicines against the need to scale production and improve...

Pharmaceutical manufacturers working with hazardous and difficult-to-control chemical reactions face challenges in managing process safety, heat transfer, and reaction conditions. Flow chemistry offers an alternative to traditional batch processing in applications where improved mixing, temperature control, and smaller quantities of hazardous materials in the reactor can help reduce operational ri...

Increased regulatory scrutiny, onshoring efforts, and supply chain vulnerabilities are reshaping how life sciences manufacturers are making investment decisions across the industry. Pharma manufacturers are weighing facility locations, workforce availability, and manufacturing costs while looking for ways to strengthen supply chain resilience and improve operational efficiency. In this episode of...

Life sciences manufacturers are cautiously optimistic about the potential for emerging technologies like AI, robotics and automation to improve manufacturing operations. While many manufacturers anticipate that these technologies will drive greater operational efficiencies and lower the cost of goods, concerns still remain about affordability, integration into regulated manufacturing environments...

Life science manufacturers are investing in expanded production capacity while rethinking facility design and technology strategies to improve efficiency, manage costs, and prepare for the future. Balancing upfront investments with long-term operating costs, while navigating the opportunities of automation, single-use technologies and AI, is becoming an increasingly important part of manufacturing...

As biopharmaceutical manufacturers work to accelerate facility timelines while managing complex production environments, greater integration between automation, manufacturing systems and other digital technologies is becoming essential. Moving to more connected manufacturing is also driving companies to rethink how different capabilities are brought together, including a growing focus on integrati...

While artificial intelligence is expected to transform biopharmaceutical manufacturing, many manufacturers still face challenges in adopting these technologies at scale. Fragmented data, disconnected manufacturing systems and differences in how information is shared across organizations are creating barriers to AI adoption, raising questions about what manufacturers need to prioritize before inves...

The pipeline of biologic products entering the market is becoming increasingly complex, and biomanufacturers are incorporating newer technologies and manufacturing strategies into their processes to meet unique production needs. CDMOs, for example, are developing advanced platforms to improve their adaptability and flexibility as the biologics market continues to grow and evolve. In this episode o...

The Trump administration’s plan to impose 100% tariffs on imported generic drugs by August 2028 is spurring conversations about whether manufacturers can realistically reshore production before that deadline. But bringing production back to the U.S. will require more than tariffs alone, as manufacturers consider challenges around cost, capacity, workforce and infrastructure.  In this episode of Of...

Researchers have developed a new sensor-enabled bioreactor that uses machine learning technology for improved enzyme production. This advanced technology—created by researchers at Iowa State University and Novonesis , with funding by BioMADE —pairs continuous monitoring with AI-guided control to give manufacturers a faster, more precise way to manage enzyme production. In this episode of Off Scrip...

Sterile ophthalmic manufacturing is facing growing demand as more preservative-free therapies move through development, while manufacturers also contend with increasingly stringent expectations around contamination control, inspection, and quality. Blow-fill-seal (BFS) technology offers a closed, highly automated approach that can reduce contamination risks while producing billions of unit doses a...

Radiopharmaceuticals are a rapidly growing area of oncology, fueled by advances in targeted therapies and expanding product pipelines. But bringing these therapies from development to commercialization presents unique manufacturing challenges, from isotope supply and specialized GMP facilities to the “just-in-time” distribution models required by the short half-lives of these radioactive medicines...

The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful tool to help quality professionals synthesize information more efficiently, improve consistency across investigations, and support more informed decis...

Single-use technologies have reshaped biopharma manufacturing facility design, capacity strategy, and flexibility over the past decade. The industry has expanded with a growing range of targeted therapies and emerging modalities, which has led to manufacturers adopting single-use systems to meet demand. The shift has enabled more flexible facilities, faster product changeovers, and manufacturing s...

Biopharmaceutical manufacturing processes are becoming more complex, prompting manufacturers to evaluate filtration based on its impact across the entire process rather than as a standalone unit operation. Filtration decisions can influence everything from system footprint and flow performance to integration complexity, product recovery, and overall operational efficiency. Growing emphasis on sust...

A unique team of specialists in data generation and artificial intelligence are co-developing an AI genomic model capable of predicting genomic edits that improve commercial-scale protein production. This collaboration between Triplebar and UC Berkeley —with funding from the U.S. Department of Defense and the National Science Foundation through a BioMADE grant—aims to accelerate strain optimizatio...

The FDA recently announced the participants in its PreCheck pilot program, an initiative designed to encourage earlier collaboration between regulators and companies developing new domestic pharmaceutical manufacturing facilities. By shifting facility readiness discussions earlier in the development process, the program aims to improve regulatory predictability, reduce manufacturing risk, and acce...

As pharmaceutical manufacturers work to reduce energy consumption and meet sustainability targets, attention is expanding beyond core production processes to the utility systems that support manufacturing. Steam systems, which play a critical role in sterilization, heating, and HVAC operations, can account for a significant share of a facility's energy consumption. Yet things like manual inspectio...

The advancement of pharmaceutical manufacturing depends heavily on the research taking place in areas such as continuous manufacturing, automation, machine learning, and AI. The maturation of these technologies will foster improved process optimization, accelerate the development of medicines, and make manufacturing more efficient and reliable. This is the second part of our conversation with Thom...

The framework of modern pharmaceutical manufacturing is evolving as new technologies, advanced therapeutic modalities, and more sophisticated process control reshape how medicines are developed. While biologics, peptides, and other emerging therapies continue to expand the industry's capabilities, advances in engineering, automation, and continuous manufacturing are also transforming small molecul...

Biopharmaceutical manufacturers are facing mounting pressure to scale production faster while maintaining quality and operational reliability due to the ever-expanding pipeline of therapies. Meanwhile, onshoring initiatives, increasingly complex facilities, workforce challenges, and rising demand for biologics are exposing limitations in traditional manufacturing approaches. As a result, organizat...

Amid ongoing geopolitical uncertainty, regional manufacturing initiatives, and evolving supply chain risks reshaping the pharmaceutical industry, manufacturers are rethinking how biologics are produced and delivered around the world. Rather than relying on centralized production models, many organizations are expanding regional manufacturing footprints and developing more integrated production net...

As biopharma pipelines become more complex and market conditions continue to evolve, manufacturers are rethinking how they scale capacity, deploy capital, and build supply chains. The industry’s focus is increasingly shifting toward developing the flexibility, resilience, and specialized capabilities needed to support rapidly evolving therapeutic modalities. At the same time, regionalization effor...