Biopharmaceutical Contract Manufacturing Europe | Pharma Tech Outlook Magazine
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BioConnection

Merging Big Pharma Expertise with Biotech Agility

BioConnection is the bridge the industry needs. It blends the agility and personal touch of emerging biotech companies with the expertise of big pharma. While larger CMOs may treat clients as just another project in a long queue, BioConnection maintains a high level of personal interaction and tailored service. Clients are never mere numbers. This personalised approach, combined with in-house expertise typically found in top-tier CMOs, sets BioConnection apart in the market. Formed through a public-private partnership between Organon, then a part of AkzoNobel Pharma, and the Dutch government, BioConnection’s roots are deeply embedded in industry innovation. From the outset, Organon’s cutting-edge facilities became BioConnection’s foundation, empowering emerging biotech companies to turn their ideas into market-ready products. This spirit of collaboration laid the groundwork for a strong network of trusted partners, enabling it to provide end-to-end pharmaceutical development and manufacturing services. Today, BioConnection is known for specialising in the development, manufacturing, filling and freeze-drying of injectable biopharmaceutical products, from concept to commercialisation, with uncompromised quality and reliability. “Think of us like a boutique hotel,” says Alexander Willemse, CEO. “While we provide the same top-tier capabilities as larger CMOs, our approach is flexible. Our clients appreciate the individualised attention and agility we bring to each project without sacrificing the quality or expertise they would expect from a large-scale partner.” A critical gap it addresses in the pharmaceutical lifecycle is the transition from clinical trials to commercial manufacturing. This is often the most challenging point for biotech companies. Scaling up requires access to specialised facilities, advanced technology and a higher level of regulatory compliance, areas in which many small firms lack experience and resources. Without the right CMO, companies face costly delays and disruptions.

Innovative API Manufacturing

Axplora

Agile Partner for API Process Development and Manufacturing

M. Jean Bléhaut, CDMO BU President

The European pharmaceutical contract development and manufacturing organization (CDMO) market is expanding rapidly due to increased pharmaceutical demand, rising healthcare expenditure, and the advent of disruptive technologies. To succeed in this market, manufacturers must ensure that their facilities, processes, and equipment adhere to strict regulatory requirements and standards, guaranteeing product safety and efficacy. Moreover, they must adopt a continuous improvement mindset to address the specialized equipment and manufacturing processes needed for targeted therapies. Axplora, a company specializing in developing and upscaling complex API production processes, tackles these challenges effectively. Axplora has facilitated FDA approval for 13 new customer drugs in the past five years and is a dependable and agile partner for process development and API manufacturing. The firm has adapted its facilities to handle increasingly complex molecules and invested in new continuous technologies such as chromatography, electrochemistry & flow chemistry. “With our outstanding team of over 120 process development experts and 20 dedicated project managers we provide expertise and service excellence. We have an impressive track record, demonstrated by our successful transfer and validation at scale, of a complex, multi-step API within six months,” says Mr. Jean Bléhaut, CDMO BU President, Axplora. The firm’s expertise in hazardous chemistry enables it to use energetic reagents and chemicals to yield efficient synthesis routes with fewer steps and a lower mass intensity. Axplora is recognized as a leader in the manufacture of antibodydrug conjugates (ADC) and steroids, also leveraging technologies such as HPAPIs and cryogenic chemistry.

IN MY OPINION

Pharma Manufacturing

Shaping the Next Chapter of Manufacturing

Chow Woai Sheng, Vice President of Global Instrument Manufacturing and Singapore General Manager, Agilent Technologies

LAST WORD

Pharma Marketing

From Pharmaceutical Parallel Importer to Building Brands

Line Bentsen Zacho, Marketing Director, Orifarm

IN FOCUS

Sustainable Practices in European Biopharmaceutical Contract Manufacturing

Europe's biopharmaceutical industry prioritises sustainable practices due to regulatory mandates, consumer expectations, and environmental concerns. Contract Manufacturing Organizations invest in renewable energy and green chemistry.

Learn more

Europe's cmos: Catalysts for biopharma Growth

The biopharmaceutical industry has experienced significant growth in recent years, fueled by advances in biotechnology and the rising demand for innovative therapies.

Learn more

EDITORIAL

Biopharma’s Next Frontier— Innovation, Agility and Growth

The biopharmaceutical contract manufacturing landscape is evolving rapidly, emerging as a critical enabler within the broader pharmaceutical supply chain. This transformation is driven by the escalating demand for biologics and advanced therapies, which offer unprecedented specificity in targeting complex diseases. As biopharma companies accelerate innovation, they increasingly rely on contract manufacturing organisations (CMO) not only for production capacity but for strategic partnerships that provide access to specialised expertise and scalable technologies.

A prominent shift within this sector is the increasing implementation of single-use technologies (SUT). These systems fundamentally alter biomanufacturing paradigms by enhancing operational flexibility and process efficiency. SUTs mitigate contamination risks and substantially reduce turnaround times by eliminating the need for cleaning validation, while also lowering capital expenditures associated with traditional stainless-steel systems. For CMOs, this evolution enhances their ability to meet client demands for rapid, adaptable production, supporting faster commercialisation timelines.

At the same time, the adoption of advanced digitalisation and automation technologies is redefining the operational landscape for CMOs. Integrating artificial intelligence, advanced analytics, and automated systems has enabled these organisations to optimise manufacturing workflows, ensuring consistent product quality and regulatory compliance. By leveraging data-driven insights, CMOs can achieve greater process control, predictive maintenance, and real-time monitoring, collectively enhancing product reliability. Moreover, digitalisation facilitates traceability and end-to-end visibility throughout the production lifecycle, critical for maintaining transparency with regulators and fostering greater trust within the biopharma ecosystem.

Driven by these trends, the global biopharmaceutical contract manufacturing market is estimated to reach US$ 25.1 billion by 2034, growing at a CAGR of 8.8 percent.

This edition of Pharma Tech Outlook offers insights into the latest biopharmaceutical contract manufacturing industry developments and how companies align with these trends.

This issue features a thought leadership article by Chow Woai Sheng, Vice President of Global Instrument Manufacturing and Singapore General Manager at Agilent Technologies. He explores how manufacturers can leverage Fourth Industrial Revolution (4IR) technologies to drive productivity, sustainability and supply chain resilience. Additionally, an article by Ozgur Akbulut, Director, Contract Manufacturing Lead at Takeda, examines the evolving landscape of contract manufacturing organisations (CMOs/ CDMOs) in the pharmaceutical industry, outlining key expectations pharma companies have from their CMO partners, including quality, supply reliability, competitiveness and value creation.

In this edition of Pharma Tech Outlook, we also bring you the story of BioConnection, a boutique contract manufacturing organisation (CMO) that bridges the gap between big pharma expertise and biotech agility. With a personalised approach and a focus on injectable biopharmaceuticals, it offers end-to-end services from development to commercialisation. It specialises in navigating the challenging transition from clinical trials to commercial manufacturing, particularly for small indications and orphan drugs.

In this edition featuring the number one European company in biopharmaceutical contract manufacturing in 2024, we hope you find the right partner to meet your organisation’s needs.

Let us know your thoughts!