IPSC Manufacturing: From Dolly the Sheep to Clinical-Grade Cell Therapies

"The manufacturing process doesn't just produce the product — it determines what the product becomes." Stephen Sullivan, Founder of Linville Bio, brings more than two decades of experience spanning developmental biology, clinical translation, and manufacturing strategy across organizations, including Novartis and the Global Alliance for iPSC Therapies. Most recently, he led the setup of a first-in-human trial for an iPSC-based cancer vaccine.In this PharmaSource podcast episode, Stephen discusses the manufacturing challenges involved in induced pluripotent stem cell (iPSC) therapies and why companies that treat it as a downstream operational problem rather than a core product design decision are setting themselves up to fail.Read more.

"If I have one more person talk to me about agentic AI and then realize they're still using paper batch records, I'm going to scream." That frustration captures the central tension in CDMO digital transformation today says Matt Lowe, Chief Strategy Officer at MasterControl.Matt has spent nearly two decades at MasterControl, rising to CSO with responsibility spanning competitive intelligence, strategic partnerships, pricing, and product direction, making him one of the industry's sharpest observers of where life sciences manufacturing technology stands and the distance it still needs to travel.In the latest PharmaSource podcast episode, Matt maps the digital manufacturing journey contract development and manufacturing organizations (CDMOs) must take, from eliminating paper on the shop floor to achieving the industry's most coveted goal: golden batch and real-time release.Read more

“Aligning development strategy early creates a real competitive advantage. When scalability and late-stage requirements are already considered during Phase I and II, you avoid gaps that cause delays further down the line.”Eike Cordts, Director Early Stage Development USA, Rottendorf Pharma, leads early stage development initiatives in North America for Rottendorf Pharma, a German CDMO with nearly a century of expertise in oral solid dosage (OSD) forms. Having grown from 800 to over 1,400 employees in the past decade, Rottendorf Pharma recently formalized a strategic transatlantic partnership with Corealis Pharma, a Canadian early-phase OSD specialist. In this PharmaSource podcast episode, Eike explains the strategic thinking behind the alliance and what it means for pharmaceutical companies seeking an integrated development-to-commercialization pathway.Read more.

“Capacity isn’t the biggest gap. It’s people. And nobody’s talking about it.”For pharma and biotech companies, manufacturing combination devices means coordinating not just fill/finish manufacturing but also primary container selection, device sourcing, final assembly, and serialization — often across multiple specialist partners. As CDMOs expand their service offerings to take on more of that coordination, including final device assembly and primary container management, the boundaries of what a fill/finish partner is expected to deliver are shifting.In the latest PharmaSource podcast episode, Steven Kaufman — who has spent over 20 years in the drug delivery device space and now advises biotech companies and CDMOs on combination product strategy — breaks down where the complexity really lies, why fill/finish capacity remains so tight, and what smart companies are doing differently to protect their programs.Read more.

“Don’t pick a CMO that just agrees with you.”Isabel Feuerstein is Head of Business Development for EU and Asia CMO at Novartis, where she shapes the company’s contract manufacturing strategy across key global markets. Mark Schiefermeier leads the manufacturing unit at DS Schaftenau, one of Novartis’ critical drug substance manufacturing facilities in Austria, overseeing technical execution and quality systems that underpin Novartis’ external manufacturing commitments.In this episode of the PharmaSource podcast, Isabel and Mark explain why technical credibility, real transparency, and a willingness to challenge clients are the foundations of a high-performing CDMO relationship — and how Novartis is positioning its CMO business for the future of biologics.Read more.

"Every milliliter lost translates to delayed timelines and increased costs."For early-phase biotech companies working with limited API batches, this is the central challenge of sterile injectable manufacturing. Peter Mollison, CEO and co-founder of Eramol, a UK-based pharmaceutical CMO, has built an entire facility around solving it.Peter Mollison and David Cox, Site Director at Eramol, joined the PharmaSource podcast to discuss the company's new purpose-built sterile injectable facility opening in Q2 2026 in Sittingbourne, Kent. The 11,000-square-foot site features a 2,000-square-foot GMP Grade A/C/D clean room suite engineered to achieve less than 1% material losses, well below the industry standard of approximately 10%.In this episode, Peter and David explain the engineering decisions behind the low-waste design, how the facility's end-to-end capabilities simplify outsourcing for biotech, academia, and research clients, and what it takes to build a sterile manufacturing site that meets 2023 EU GMP Annex One standards.Read more.

“One day lost during a clinical phase is one day of peak sales that is lost — always.”Nicolas Ragot, Chief Executive Officer of Delpharm, brings over three decades of pharmaceutical manufacturing expertise, having started his career as a process engineer at Eli Lilly before progressing through technical and leadership roles at Procter & Gamble Pharma and GSK. He joined Delpharm in 2018 as Chief Operating Officer and assumed the CEO role in 2024.In this episode of the PharmaSource podcast, Nicolas explains why supply reliability, digital standardization, and long-term partnership thinking are the strategic pillars that allow Delpharm to differentiate in an increasingly consolidated CDMO market — and why time to market is the single most important criterion any biotech should use when selecting a manufacturing partner.Read more.

“We’re witnessing what I would consider the most structurally disruptive pharmaceutical moment I’ve seen in my career—and it’s being driven by consumers.”Ryan Kelly, Interim CEO and Senior Director of Supply Chain Security and Brand Protection at Rx-360, has seen pharma’s direct-to-consumer transformation from multiple angles—building pharmacy operations at Amazon during the PillPack acquisition, scaling the largest cash pharmacy in the U.S. at Chewy, and now leading supply chain security for a 130-member industry consortium. His verdict: the infrastructure isn’t keeping up.In the latest PharmaSource podcast episode, Ryan explains why GLP-1 demand and the rise of direct-to-consumer platforms such as TrumpRX have become the stress test pharma’s supply chain never prepared for—and what manufacturers need to do before the system breaks.

"Sponsors don't want to know how many SOPs you have on the shelf. They're really looking to see if you have sound judgment to take care of their program." Mohamad Ahmad, Vice President of Quality and Compliance at the Biologics Manufacturing Centre (BMC) Inc., brings extensive quality leadership experience across the pharmaceutical industry. The BMC is a Canadian non-profit CDMO established in response to Canada’s effort to strengthen domestic biologics manufacturing capacity following the pandemic. There, Mohamad oversees quality systems across all biologics manufacturing operations, from early clinical through commercial scale.In this episode of the PharmaSource podcast, Mohamad explains why a risk-based, science-driven approach to quality is the defining factor that separates strong CDMO partners from the rest — and how the BMC has built its quality organization to deliver that across every stage of a program's lifecycle.Read more.

“The level of comfort with AI use in this space is pretty low right now.” Mike Boyson’s observation cuts to the heart of pharma’s AI dilemma. Hesitation is justified—but it shouldn’t paralyze action. His answer: build practical, compliant digital twins that operators can create in Claude without waiting for IT.Mike is a supply chain and pharmaceutical operations leader with over 20 years of experience spanning CMC strategy, external manufacturing, and digital transformation. He spent more than a decade at Takeda leading oncology and biologics supply chain operations, served as Executive Director of Value Chain Leadership at Moderna, and now advises organizations at Azure Biopharma Consulting on adopting AI-driven solutions.In a recent PharmaSource podcast episode, Mike shares concrete use cases for digital twins, explains how to build them without deep technical expertise, and addresses the GXP compliance, data confidentiality, and human-centered challenges that will define pharma AI adoption.Watch the video to accompany this episode here