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Dipharma

Empowering Your Journey From Molecule To Market

When driving innovation in the pharmaceutical industry, accelerating the drug development process is crucial. Dipharma is here to simplify this journey. As a global CDMO and a leading manufacturer of active pharmaceutical ingredients and intermediates, Dipharma turns challenges into opportunities. Instead of juggling multiple CDMOs, Dipharma supports customers as a one-stop partner from pre-IND to market, ensuring seamless compliance in every market. This holistic approach shortens timelines, optimises resources and allows clients to focus on what matters most: delivering life-changing therapies to patients. How does Dipharma make it happen? Its four facilities, strategically located across the U.S. and Europe, are built to satisfy customers’ needs while adhering to the strictest regulatory standards. The three facilities in Italy, certified by Agenzia Italiana del Farmaco (AIFA) on behalf of the European Medicines Agency (EMA), have also earned approval from major regulatory agencies worldwide, most notably the FDA since 1970, the Japanese PMDA, the Korean KFDA and the Brazilian Anvisa. In the U.S., the Kalamazoo-based former Kalexsyn Inc., a world-class contract research organisation (CRO) founded in Michigan in 2003, was acquired by Dipharma in 2018 and underwent a thorough transformation into a small-scale GMP site, culminating in a successful FDA preapproval inspection at early 2024. This harmonised and impeccable compliance track record guarantees every molecule produced at Dipharma’s facilities meets the highest global standards. Transparency Built to Last At Dipharma, client communication is key. They assure every client is always engaged and well-informed The dedicated team provides daily updates and weekly video calls, fostering seamless communication and collaboration throughout the CDMO project. The core team, including a Project Manager, a Technical Manager and Subject Matter Experts, oversees every phase, maintaining consistency and smooth transitions. The commitment to transparency reflects Dipharma’s dedication to client satisfaction, distinguishing it in the industry as a partner that truly values open collaboration. “We manage intricate projects with agility, adjusting to changing demands and timelines. This balance of scale and flexibility positions us as a preferred partner in the industry,” says Andrea Confetti, Exclusive Synthesis BU leader. Dipharma’s independence from external investors ensures solid ethics, unbiased decision-making and the ability to meet clients’ needs without delay. The unwavering commitment and strategic insight guarantee project success.

Top Pharmaceutical Sterilization Solutions in Europe 2025

De Lama

Building a Legacy of Stronger, Smarter Industrial Sterilisation

Marco Bianchi, Marketing, Sales and Communication Manager and Guido Rovera, Director of Sales and Marketing

Seventy-five years ago, De Lama pioneered Italy’s first industrial steriliser, setting a legacy of engineering excellence that continues to define the global sterilisation landscape. When Franco De Lama founded the company, he saw a future where sterilisation technology would be indispensable to pharmaceutical and biotech industries. That vision led to the development of a compact saturated steam steriliser, a breakthrough that made high-grade sterilisation accessible to laboratories and emerging pharmaceutical firms. Over the decades, the company has continuously expanded its portfolio, introducing advanced sterilisation technologies—including dry heat, air steam water, superheated water, and ethylene oxide (EtO) sterilisation— each designed to meet regulatory requirements while solving industry pain points. But innovation is only part of the story. De Lama stands out for its deep engagement with clients. “Our niche in pharmaceutical production has allowed us to build an unrivalled expertise in sterilisation—not just by refining technology, but by listening to our customers,” says Guido Rovera, director of Sales and Marketing. “We understand their challenges firsthand and engineer solutions that make a measurable difference. Our history is our foundation, but our focus is always on what’s next.” That customer-first approach led to one of De Lama’s pinnacle innovations—HyPerPure®, a sterilisation technology that overcomes the limitations of traditional methods. When a pharmaceutical client needed to sterilise a heat-sensitive syringe containing blood derivatives, conventional methods weren’t an option. Heat would degrade the product, while EtO posed toxicity risks, regulatory burdens and environmental concerns. De Lama responded with HyPerPure®, which achieves a log 12 reduction, matching the sterility assurance levels of saturated steam sterilisation but without the drawbacks. The impact is undeniable. HyPerPure® ensured uncompromised sterility for even the most heat-sensitive products while cutting energy consumption by 70 percent compared to saturated steam sterilisation. It completely eliminates water waste, reducing environmental impact and operational costs. And by drastically lowering CO₂ emissions, it helped the client meet sustainability targets without compromising on performance. As corporations worldwide—from global enterprises to mid-sized and small businesses—accelerate their pursuit of net-zero CO₂ targets, sustainability has become a decisive factor in equipment selection. “Our technology directly impacts their choices, favouring solutions that align with their sustainability goals,” says Marco Bianchi, marketing, sales and communication manager at De Lama.

IN MY OPINION

CMO

How CMOs/CDMOs can Add Value for Pharma Companies

Ozgur Akbulut, Director - Divestment and Contract Manufacturing Lead, Takeda

LAST WORD

CRO

Digital Health: A New Experience in the Healthcare System

Stefania Alvino, Head of Digital Innovation - DSPACE European Digital Hub Department, Daiichi Sankyo

IN FOCUS

Italy's Leadership in Pharmaceutical Sterilisation

Pharmaceutical sterilisation is a crucial discipline that upholds medicinal products' safety, efficacy, and quality.

Learn more

Navigating the CDMO Landscape in Europe: Trends and Challenges

Contract development and manufacturing organizations (CDMOs) provide end-to-end services, from drug development to commercial manufacturing, enabling pharmaceutical establishments to bring innovative treatments to market.

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EDITORIAL

Global Excellence in European Pharma Manufacturing

Pharmaceutical sterilisation solutions have transformed far beyond traditional autoclaves and ethylene oxide chambers, driven by a surge in outsourcing to specialised providers and the relentless demand for regulatory compliance. This change is propelled by the swift integration of next-gen sterilisation techniques—vaporised hydrogen peroxide, electron-beam irradiation and precision-engineered membrane filtration.

Together, these methods achieve true “molecular level” cleanliness. They inactivate or remove contaminants at the smallest scales, delivering unmatched safety, shorter cycle times and compatibility with today’s most advanced pharmaceuticals.

Meanwhile, the contract development and manufacturing organisation (CDMO) landscape has become the premier destination for pharma firms seeking agility, specialised expertise and cost efficiency. By leveraging CDMOs’ integrated service platforms, from early-stage process development to commercial-scale manufacturing, pharmaceutical companies are shifting investment away from fixed infrastructure, accelerating their development timelines, and focusing squarely on innovation and patient outcomes.

Driven by these trends, the pharmaceutical sterilisation market is projected to reach $1.6 billion by the end of 2030, growing at a CAGR of 10.1 percent, and the CDMO market is projected to reach $88.8 billion at a CAGR of 7.7 percent by the end of 2034.

This edition of the Pharma Tech Outlook Europe offers a detailed look into the latest innovations and how companies align with these trends.

The magazine features a thought-provoking article from Liselotte Hyveled, Chief Patient Officer and Board member at Novo Nordisk. In it, she advocates for a transformative shift in the pharmaceutical industry—one that places patients at the centre of every stage of drug development, from research and clinical trials to regulatory approval and post-market care. Another article by Stefania Alvino, Head of Digital Innovation-Customer Experience Excellence Department & DSPACE at Daiichi Sankyo, wants to emphasise the transformative power of digital health. She underscores how technology is not just enhancing but redefining the experience of patients and healthcare professionals by enabling a more personalised, data-driven and patient-cantered approach.

We also bring you top pharmaceutical sterilisation and CDMO solution providers who offer cutting-edge products and solutions. A noteworthy story is that of Dipharma.This well-established company provides end-to-end solutions for its clients, seamlessly covering every development and manufacturing phase.

In this edition featuring the Top Pharmaceutical Sterilization Solutions in Europe 2025 and CDMO Solution of the Year in Europe 2025, we hope you find the right partner to meet your organisation’s needs.

Let us know your thoughts!