How EU Sustainability Regulations Are Reshaping CDMO Manufacturing

“Rather than saying that there’s a gap from the industry, I think there’s a listening gap from our governments.”Neha Dave is an independent EU Government Affairs Advisor based in Brussels, with more than 20 years of experience across the EU institutions, agency-side consulting at Weber Shandwick, and government affairs and public policy at MedTech Europe. She advises pharma and medtech companies on entering and navigating the European market, with policy expertise spanning pharmaceuticals, MDR/IVDR, clinical trials, and the single market.In the latest PharmaSource podcast episode, Neha explains how EU regulation, particularly the environmental and sustainability agenda, is landing on contract manufacturers, which legislation is already in force, what arrives in the next 12 to 18 months, and what CDMOs should be doing now to prepare.Read the full article.

Moderated by Raman Sehgal, Host of Molecule to Market, this opening panel at CDMO Live Europe 2026 brought together Melanie Wamsler, External Network Strategy Lead, Takeda, Rocco Paracchini, Vice President, Morpho, Kaan-Fabian Kekec, Partner, Simon-Kucher, and Kurt Nielsen, President, Longview Leader, to assess market conditions, capital discipline, geopolitical risk, and pricing in contract manufacturing.Read the full article.

“There isn’t enough capacity for antibody-oligo conjugates out there today, full stop,” says Geoff Glass, CEO of Abzena. “And it’s really because of the volume requirements for the diseases.”Geoff Glass is Chief Executive Officer of Abzena, the end-to-end, fully integrated CDMO and CRO for complex biologics and bioconjugates. He brings 30 years in life sciences, including at Patheon, Avadel, and Ncardia, and he chaired Abzena’s board before taking the CEO seat last year. He’s joined by Campbell Bunce, Abzena’s Chief Scientific Officer, who runs discovery through GMP manufacturing across the company’s San Diego, CA, Bristol, PA, and Cambridge, UK sites.Antibody-oligonucleotide conjugates (AOCs) have moved from concept to late-stage development in just a few years, attracting major investment along the way. In the latest PharmaSource podcast, Geoff and Campbell walk through where the modality came from, manufacturing considerations compared to ADCs, and the broader geopolitical and capacity challenges in the US.Read the full article.

“If you look at the employment numbers in the manufacturing sector, it’s been absolutely flat for two years. The political noise has not driven that big wave of reshoring that we were expecting.” After a decade of making the economic case for bringing manufacturing back to America, Rosemary Coates says the data tells a very different story from the press releases.Rosemary Coates is Executive Director of the Reshoring Institute and President of global supply chain consultancy Blue Silk Consulting, with 35 years of experience across industries from healthcare to high tech. She has consulted for over 80 clients worldwide, served as an expert witness in major supply chain disputes, authored five books including the Amazon bestseller 42 Rules for Sourcing and Manufacturing in China, and was named one of the 100 Most Influential Women in Silicon Valley in 2024.In the latest PharmaSource podcast episode, Rosemary explains what the data really says about reshoring to the US, why tariff volatility has frozen executive decision-making, and how pharmaceutical companies can build manufacturing strategies durable enough to survive an unstable world.Read the full article.

“No one is going to care about your project as much as you do.” Steven Weissman is Vice President and Head of CMC at Cognition Therapeutics, a small pharma company outside New York City developing CT1812, a neurodegeneration candidate now through three Phase 2 trials in Alzheimer’s disease, Lewy body dementia, and dry AMD. He spent 18 years in the process chemistry groups at Merck before moving into the small pharma space, where he has managed CMC functions at Concert Pharmaceuticals, Lexicon, and now Cognition Therapeutics.In the latest PharmaSource podcast, Steven explains how small biotechs can build a manufacturing supply chain from scratch, why cost of goods is a lever most teams pull too late, and what working on drugs that made it to market, and some that didn’t, taught him about when to invest in process development.Read the full article.

“Digital collaboration is a competitive advantage for everyone — for CDMOs and CMOs, it’s not a question of if you’re going to do it, it’s when. So how do you get ready for it?”At CDMO Live Europe 2026, Sham Afzalpurkar, CEO of Collabrix, presented a standards-based, AI-enabled framework for connecting sponsor-CDMO networks at scale, arguing that custom point-to-point integrations are structurally unsustainable as external manufacturing portfolios grow.Read the full article here.

“When we go to an external partner, we need to show up as one single aligned organization. If we’re not aligned internally, the CMO ends up becoming the referee.” In pharmaceutical manufacturing, the quality of a CDMO partnership is rarely determined by the contract alone. According to Sabrina Mattos, Senior Director of External Manufacturing for the Americas at Elanco, what truly separates high-performing partnerships from dysfunctional ones comes down to two factors: internal alignment and cultural intelligence.Sabrina brings over 20 years of pharmaceutical industry experience spanning quality, supply chain, and operations leadership across Brazil, Europe, and North America. As a pharmacist who began her career as a QA representative at Eli Lilly in Brazil, she has progressed through site leadership and global roles to now oversee Elanco’s external manufacturing portfolio across the US, Canada, and Latin America — a hub spanning close to 50 CMO relationships.In a recent PharmaSource Podcast conversation, Sabrina shared how Elanco structures its external manufacturing teams, navigates the cultural differences that shape partnerships across the Americas, and why getting internal alignment right before approaching a CDMO is non-negotiable.Read the full article.

At CDMO Live Europe 2026, Jeff Mason, VP and Head of US Sales at Samsung Biologics, demonstrated a risk-based, parallel approach to dual-site technology transfer that delivered a first GMP batch at a second facility within 90 days of initiation.Read the full article.

When relationships with contract manufacturers break down, the cause is rarely just the contract manufacturer. A panel of three sponsor-side executives examined the warning signs, the internal failures, and the governance models that determine whether a difficult relationship recovers or ends.At CDMO Live Europe 2026, a session, moderated by Raman Sehgal of the Molecule to Market podcast, brought together three buyers: Stefan Bouckaert, a Quality and Operations Leader who spent 20 years at Johnson & Johnson overseeing 170 contract manufacturing organizations and 5,500 suppliers; Nick Wark, Head of External Manufacturing and Strategic Partnerships at Ferring Pharmaceuticals, overseeing several dozen contract manufacturers; and Oksana Vodovska, Business Development Manager at Sopharma, a regional generics company that selectively outsources alongside its own production facilities.Read the full article.

“The least expensive CDMO on the first day of bidding may not be the optimum value CDMO three years later.”Choosing a contract development and manufacturing organization is not about who quotes the lowest unit price. It’s mainly about who keeps your clinical timeline intact.Prakash Savarirayan is a life sciences procurement leader with more than two decades of sourcing experience, over a dozen years of it in biopharma, including senior roles at Takeda (formerly Shire) and Roche’s Spark Therapeutics. He has led complex CDMO partnerships, supported M&A integrations, and built governance models across small molecules, biologics, and gene therapy, and now advises pharma and biotech clients in consulting capacity.In the latest PharmaSource podcast episode, Prakash explains why getting CDMO selection right matters more than negotiating the lowest price, how procurement earned a strategic seat at the table, and why the right partner protects both patient safety and enterprise value.Read the full article.