Read about Fill & Finish services in Contract Pharma Magazine
- Mabion’s photo was chosen as the cover of the March issue of Contract Pharma Magazine.
- Ewelina Zielińska-Rosik, Production Division Manager at Mabion, discusses the key role of regulatory compliance in the current Fill & Finish environment.
The Fill & Finish stage of pharma manufacturing may not make headlines, but it is the final crucial step – the point where all the work behind a new drug either comes together or falls apart due to contamination, inefficiencies, or regulatory setbacks. Right now, the demand for adaptable Fill & Finish services is soaring. Mabion Biologics CDMO offer the expertise, flexibility, and advanced technology that pharmaceutical companies need to navigate today’s challenges.
A photo depicting a manual product inspection performed by a qualified Mabion specialist was selected as the cover of the March issue of Contract Pharma Magazine. We offer drug product inspection capabilities designed to detect and eliminate any defects or inconsistencies before the product reaches the patient. All filled, capped and corked vials undergo visual inspection and rigorous leak testing. With a focus on accuracy, efficiency and compliance, our advanced inspection systems provide complete assurance that each vial meets the highest industry standards.
Biologics are transforming the pharma industry, but their complexity demands stricter compliance. Regulatory bodies like the EMA and FDA now impose higher standards. The old vendor-client model is fading. Pharma companies now seek long-term CDMO partnerships to navigate regulations and improve efficiency. The COVID-19 pandemic accelerated this shift, highlighting the need for fast, scalable, and compliant Fill & Finish solutions. The EU GMP guidelines are evolving to meet these requirements. Changes in Annex 1 focus on contamination control, risk management and isolator technology. Predictive quality assurance is growing, using real-time data analysis and automated monitoring.
Trends in Fill & Finish Outsourcing by Contract Pharma Magazine
Compliance is no longer just an exercise in ticking off the right boxes, but a competitive differentiator for CDMOs looking to establish their credibility in the industry. This was perfectly recounted by Ewelina Zielinska-Rosik, Production Division Manager at Mabion, in her exclusive Contract Pharma segment of the roundtable. Below is a brief snippet of her statement:
As the pharma world pivots to biologic drugs, which are trickier to craft than the usual small molecules, the call for expert Fill and Finish services has intensified (…). The rise of monoclonal antibodies, ADCs, and other recombinant proteins treatments has made expert fill and finish solutions essential to ensuring product integrity from production to patient delivery.
We are proud to be able to present our specialists to the world. We want to share insights with biopharma companies and build long-term relationships. For years, we have been characterized by our focus on customer needs and a “can-do” approach.
If you are interested in cooperation, do not hesitate to write to email: bd@mabion.eu. We will support your project.
Take an inside look at our Fill & Finish services.
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Sources and further reading
- Fill‐Finish Outsourcing Trends, Contract Pharma Magazine, March 2025, 16-23.
- Mabion Capacity Update: Fill/Finish, Outsourced Pharma, July 2024.