PharmaSource Podcast

Container closure integrity (CCI) is a critical element of sterile product quality, but evaluating a CDMO’s CCI capabilities requires more than confirming that testing is available.
The appropriate approach depends on the drug product, container closure system, manufacturing process, lifecycle risks, and applicable regulatory requirements. For pharmaceutical companies selecting or qualifying a CDMO, understanding how a manufacturing partner approaches these variables can provide useful insight into the maturity of its overall quality program.
Oliver Stauffer, CEO of PTI (Packaging Technologies and Inspection), has more than two decades of experience in container closure integrity testing and quality risk assessment. In a recent PharmaSource podcast, he discussed several considerations for assessing CCI strategies across vials, prefilled syringes, autoinjectors, and other sterile product formats.
The discussion points to six areas sponsors should consider when evaluating a CDMO’s approach to container closure integrity.
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At CDMO Live Europe 2026, Giulio Cavalli, Principal Lead External Manufacturing, J&J Innovative Medicine; Neil Stevenson, Director, CMC Logic Consultancy; Marine Joly Battaglini, Founder, PharmDev; and Susan Reasoner, Chief Commercial Officer, BioDuro, examined how early-stage biotechs can avoid common selection mistakes, manage capacity concerns, and build CDMO relationships designed to last beyond Phase 1.

“Traditional staff augmentation says, ‘Here are the people you asked for.’ An outcome-led model says, ‘Here is the service or capability you asked for, and we are accountable and responsible for making it work.’” — Aisling Flanagan
Aisling Flanagan, Global SVP of Professional and Managed Services at Catalyx, leads people-based services for regulated manufacturing environments. She works alongside Mike Barrett, Catalyx’s director of sales and operations for the UK and Europe, who focuses on translating client needs into measurable delivery.
In this PharmaSource podcast interview, Aisling and Mike explain how pharmaceutical manufacturers can improve staffing outsourcing in pharma manufacturing by buying capability, capacity, and results instead of contractor headcount. Their recommendations cover supplier consolidation, GMP expertise, workforce retention, governance, and performance-based KPIs.
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Sponsored by Blue Jet Healthcare, this panel at CDMO Live Europe 2026 brought together Bernhard Boehm, Head of External Manufacturing Animal Health, Boehringer Ingelheim; Philip Coetzee, Director CMO Management, Daiichi Sankyo Europe; Fanny Eberhardt, Director Global Procurement, UCB; and Shiven Arora, Managing Director, Blue Jet Healthcare to debate how pharma companies are making network strategy decisions as cost pressures, geopolitical risk, and the limits of tech transfer collide.
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“AI is marketed as such an approachable, ubiquitous thing that everybody thinks they can vibe code it. Unfortunately, a lot of companies are starting to think that way,” says Kat Kozyrytska.

Kat Kozyrytska is a portfolio strategy and technology leader in life science technologies who has operated across organizations, including Sartorius and Thermo Fisher, and now advises across the life sciences ecosystem. Her work focuses on translating emerging technologies, including AI, automation, and digital capabilities, into portfolio strategy, partnerships, and business growth.

Ahead of CDMO Live Americas, Kat explains why many of the assumptions shaping AI adoption in drug discovery do not translate into biopharma manufacturing. She covers the evolving questions around intellectual property and learning rights, why building AI in-house may be the wrong long-term choice for many companies, and why manufacturers need to move from experimentation toward portfolio-level prioritization if AI is to deliver sustainable business value.
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