How To Deliver a High-Concentration Bispecific Antibody Tox Batch in 4 Months

“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.

At CDMO Live Europe, Dr. Vijay Vittal Mathad, Chief Operating Officer of CRAMSN Research Park, outlined how a genuine end-to-end CDMO model reduces friction across the drug development lifecycle, from supply chain resilience to sustainability, drawing on 32 years of pharmaceutical development experience.Read the full article here.

Leon Tian, Director of US Project Management, ProBio, walked through the cell line development, high-concentration formulation, and purification workflow, delivering a bispecific antibody tox batch from a single selected clone in 4 to 5 months at CDMO Live Europe 2026.Speed is always a top priority in biologic CMC development — but most of the time, speed trades against quality or regulatory confidence. What I want to show today is that this trade-off is not necessary.”ProBio’s client brought a demanding brief: a bispecific antibody project requiring a high-concentration formulation of approximately 120 mg/mL, produced from a single selected clone, with a tox batch delivered in 4 to 5 months. Tian called it a “mission impossible” scenario, then spent the session methodically explaining how ProBio’s platform addresses each part of that challenge.Read the full article.

“Environmental Sustainability can be a substantial differentiator for CDMOs”Jürgen Wieland, Development Environmental Sustainability Lead at Novartis, is engaged to integrate sustainability into development processes, including reducing the emissions of clinical trials.  Jürgen brings over 20 years of finance and controlling experience to his sustainability role at Novartis, where he’s responsible for embedding environmental considerations across R&D and clinical operations. Before joining Novartis in 2011, he served as CFO of an NGO bringing solar energy to rural East Africa.In a recent PharmaSource podcast, Jürgen shares how pharmaceutical companies and their Contract, Development and Manufacturing Organization (CDMO) partners can reduce scope 3 emissions while improving operational efficiency—proving that sustainability and profitability are not mutually exclusive.Read the full article here.

At CDMO Live Europe 2026, a panel of pharma and CDMO executives examined how supply chains must be redesigned for a world of sustained geopolitical pressure, regulatory fragmentation, and accelerating demand, and where contracts, governance, and visibility fit in.This panel brought together Steve Leonard, COO, Meribel; Ryan Kelly, Interim CEO, Rx-360; Frank Binder, Managing Director, GSCA; and Maik Talarczyk, Head PMO ESO, Sandoz.Read the full article.