ADC Manufacturing: How Smart CDMO Selection Drives Speed, Safety, and Scale

“The complexity is there’s an antibody component, linker-payloads with highly potent toxic agents that need high containment, and linking a biologic with a highly potent small molecule – it’s inherently challenging.”Dr. Harch Ooi, VP of Manufacturing and Chemistry at IsoBio Inc., brings 17 years of specialized expertise in antibody-drug conjugate (ADC) manufacturing and external partnerships from Seagen (acquired by Pfizer in 2023). There, he contributed to the development and manufacturing of SGD-1006, the vedotin linker-payload that is used in Adcetris, Padcev, Tivdak, Polivy (from Genentech/Roche), and Emrelis (from Abbvie). Over the years, Dr. Ooi has witnessed the field’s dramatic transformation, from a single approved ADC in 2000 to a robust pipeline of 15 approved therapies today.In the latest podcast episode, Harch explains why mastering ADC outsourcing strategy is crucial for biotechnology companies navigating this complex modality. He shares practical insights on CDMO selection, safety protocols, and operational strategies that drive success from early development through commercial launch.Read more

"Sweden has been ranked the European Union's innovation leader for the fifth or sixth year in a row, and we're second globally. We have 4,000 life science companies—a remarkably high number for a country of 10 million people."Dr Marjo Puumalainen, International Director of SwedenBIO, brings extensive life science experience from both startup environments and academic research. Having previously served as Chief Scientific Officer at a CRISPR-based antivirals startup and completed her PhD in Switzerland, she now dedicates her role to strengthening Sweden's international presence through fostering partnerships, investments and global collaborations.In the latest PharmaSource podcast episode, Marjo explains why Sweden consistently ranks as Europe's innovation leader, how the Nordic countries collaborate rather than compete, and what makes the region attractive for international life science investment. With Nordic Life Science Days (NLS Days) taking place 13-14 October in Gothenburg, she shares insights into Sweden's unique ecosystem and the opportunities it presents for global biotech partnerships.Read full article

Carole Delauney warns that sterile injectable manufacturing “is not just fill-finish”—a misconception that can cost biotech companies millions and even derail entire drug development programs. She notes, “This is unfortunately not commonly recognized in the industry, but it is a very important topic.”Carole Delauney, a sterile injectable manufacturing expert with nearly two decades of technical expertise in contract manufacturing, has worked exclusively in sterile fill-finish since 2008. Her background in sales and business development has positioned her as what she calls a “solution provider” for complex manufacturing challenges.In a recent podcast, Carole explains why understanding sterile injectable complexity is crucial for CDMOs and biotech companies navigating a market projected to grow from $14.4 billion in 2024 to $33.7 billion by 2035 (Source: Roots Analysis). Her insights reveal critical best practices for avoiding costly mistakes and building successful manufacturing partnerships.Full article

“Siloed procurement is a big problem. We’ve recently worked with a client where a CDMO was selected simply because it could start two weeks before another. Ultimately, that led to about an 18-month delay in the project altogether.”Matthew Holt, Co-founder and Managing Director at Collaborative Sourcing, brings extensive pharmaceutical procurement expertise, from supply planning operations to managing large CMO networks. His consultancy now supports pharmaceutical companies ranging from biotech startups to established pharma giants.In the latest PharmaSource podcast episode, Matthew explains why getting CDMO selection right is crucial for project success and how a collaborative approach can prevent costly mistakes that derail timelines and budgets.Read the full article

 "Outsourcing is about giving the things you don't excel at to someone who does them exceptionally well. That's what speeds development and delivery," says Kindeva’s CEO, Milton Boyer.Milton brings nearly 30 years of pharmaceutical manufacturing experience as a contract manufacturer. He spent the first half of his career in drug substances and APIs, and the latter half in sterile drug product manufacturing before leading Kindeva's transformation into a multi-platform drug delivery CDMO.In this exclusive interview from Kindeva's new MDI Hub and UK headquarters at Charnwood Campus in Loughborough, Milton explains why strategic partnerships, sustainability initiatives, and specialized capabilities are driving the next wave of pharmaceutical outsourcing growth.

“A strategic partnerships is not a transactional relationship – it’s a partnership that should last. If we incentivise through co-investments and risk sharing, the partner can grow their business while enabling us to achieve cost and volume targets.” – Shilpi GhoshShilpi Ghosh, who leads Roche’s global CDMO operations, brings extensive expertise from chemical engineering and supply chain leadership across multiple continents. She oversees commercial aspects of Roche’s external manufacturing strategy, managing relationships with multiple external manufacturers globally.In the latest PharmaSource podcast episode, Shilpi explains why getting CDMO relationship management right is a key strategy for driving down costs, improving operational efficiency, and building sustainable partnerships that deliver results from early development through commercial launch.Read more

“Pharma consulting right now is an overgrown patch of weeds. Everybody’s just doing their own thing. It’s the Wild West compared to what it could be – an English garden.” – Ray SisonRay Sison, founder of SCxCMC exclusively speaks to the PharmaSource podcast about the launch of the Society of Professional Pharmaceutical Consultants (SOPPhC)In the latest PharmaSource podcast episode, Ray explains why he believes the pharmaceutical consulting industry desperately needs professional standards, ethical guidelines, and professional trade organization to better serve biotech clients and create sustainable working conditions for consultants. He announces the new society designed to address these critical industry gaps.Read the full article

In this episode Luke Bilton, Co-Founder of PharmaSource, shares a special announcement about CDMO Live Europe 2026 (May 19-21, Rotterdam World Trade Center). Following a sold-out inaugural event that facilitated over 1,200 targeted meetings, this pharmaceutical outsourcing event is doubling in size in 2026.Key topics covered:Why the £200+ billion CDMO sector needed a dedicated European platformNew learning tracks for External Manufacturing Strategy and Drug Development & CMCHands-on training sessions including Strategic Partnership development and Biotech CMC BootcampExpanded PartnerMatch concierge system connecting pharma companies with more than 80 CDMOsLearn more about CDMO Live Europe here

“The idea is to get the information in real time. And for that, you would go and see what systems you have at hand, what system your CMO is using, and find a joint, so called ‘Safe Space’, which serves both sides.” – Ingrid LuxIngrid Lux serves as Lead Quality Disposition in Oncology & Small Molecule External Supply Europe at Takeda, bringing extensive experience from her previous 16 years at Sandoz. Her expertise spans pharmaceutical quality management, with a particular focus on cross-functional collaboration and external manufacturing partnerships.In the latest PharmaSource podcast episode, Ingrid shares valuable insights on managing quality across external manufacturing networks, creating effective partnerships with CDMOs, and navigating the evolving landscape of pharmaceutical quality oversight in an increasingly complex global environment.Full article here

"Sustainability isn't just about doing the right thing. It's about making smarter, more cost effective decisions that are really building stronger, more reliable supply chains."Christiane Walker, Product Development Team Lead at Intelsius, believes the pharmaceutical industry stands at a critical juncture where environmental responsibility and operational excellence must converge.Christiane Walker leads the product development team at Intelsius, managing cross-functional teams that design innovative and sustainable packaging solutions. With four years at the company, she brings deep expertise in temperature-controlled transport packaging, working with pharmaceutical clients across global markets to optimise their cold chain operations.In the latest PharmaSource podcast episode, Christiane explains how pharmaceutical companies can simultaneously reduce their carbon footprint, cut operational costs, and improve supply chain resilience through strategic adoption of sustainable packaging technologies and connected digital systems.