PharmaSource Podcast

"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.
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“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.
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“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.
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“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.
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"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.
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