Off Script: A Pharma Manufacturing Podcast

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 accelerate commercial launches, an appr...

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 inspection practices and undetected steam tr...

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 Thomas Roper, PhD, co-director of pharm...

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 molecule manufacturing. These shifts are r...

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, organizations are rethinking how digital tec...

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 networks designed to improve resilienc...

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 efforts, supply chain pressures, a...

Interest in macrocyclic peptides (MCPs) continues to grow, which means manufacturers are facing mounting pressure to develop production methods capable of supporting commercial-scale demand of these molecules. While they offer a unique combination of potency, selectivity, and drug-like properties, the structural complexity of MCPs has historically made them difficult and costly to manufacture using traditional peptide synthesis tec...

As peptide therapeutics become larger, more complex, and increasingly purity-sensitive, manufacturers are confronting a new layer of execution challenges. Long-chain peptides introduce compounding scale-up inefficiencies, increasingly fragile purification requirements, and impurity profiles that become more difficult to characterize and control at commercial scale. At the same time, growing dependence on specialized amino acids, ti...

Amid increasing complexity in the drug development landscape, CDMOs are exploring new ways to streamline the path from early-stage formulation through commercial manufacturing. Rather than operating in isolated segments of the development lifecycle, some outsourcing partners are beginning to form more integrated collaborations designed to reduce handoffs, improve coordination, and simplify the client experience across multiple stag...

As pharmaceutical manufacturers push forward with massive capital expansion plans, challenges go beyond simply breaking ground on new facilities—it’s also managing the growing complexity, uncertainty, and resource strain that come with executing mega-projects. Persistent supply chain disruption, extended equipment lead times, rising material costs, and workforce constraints are forcing companies to rethink how they plan...

Rising capital investment in pharmaceutical manufacturing is pushing projects to unprecedented scale, but execution strategies haven’t fully kept pace. As companies commit billions to new facilities they’re encountering a new set of challenges around planning, coordination, and risk management. What worked for smaller, site-based upgrades is insufficient for multibillion-dollar builds involving thousands of stakeholders...

Ever since the revised Annex 1 was published, drug makers have been navigating a broader transformation of sterile manufacturing that extends beyond compliance. Contamination control, in turn, is becoming a more proactive, data-driven, and highly collaborative model, one that emphasizes continuous improvement, global alignment, and deeper integration across the supply chain. While the regulation itself builds on decades of preceden...

As the U.S. government pushes to reshore pharmaceutical manufacturing and rein in drug pricing, the implications for CDMOs and the broader outsourcing ecosystem are coming into sharper focus. While large-scale onshoring investments dominate headlines, questions remain around how policy will account for outsourced manufacturing and whether incentives align with the realities of global supply chains.

In this episode of Off Script, we...

While fully autonomous bioprocessing is within reach, adoption remains gradual as manufacturers navigate challenges around data maturity, regulatory expectations, and operational readiness. As companies modernize, the focus is shifting toward building the digital and organizational foundations needed to enable more intelligent, scalable process control, particularly through connected systems, stronger data infrastructure, and more ...

Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At ...

Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of Off Script, we spoke with Lonza's Sandro Holzer, PhD, director and head o...