Vital role of quality in biotechnology CDMO: Ensuring excellence at every step
White Paper CDMO May 2025
Quality is the backbone of innovation and success in the fast-evolving world of biotechnology, experiencing frequent launches of novel ingredients for diverse markets. Arxada’s Contract Development and Manufacturing Organization (CDMO) provides a suite of essential services, including process development, technology transfer, pilot and commercial manufacturing, and regulatory support. To ensure these services meet stringent regulatory and industry standards, robust quality management systems (QMS) are indispensable. Effective quality practices not only ensure compliance but also drive operational efficiency, product consistency, and customer satisfaction. Read on to discover how Arxada’s focus on quality transforms compliance into competitive advantage and why it might just be the key parts of your partnership.
Vital role of quality in biotechnology CDMO: Ensuring excellence at every step
In today’s global biotechnology market, particularly in the CDMO business, customer demands are increasingly complex. Even though often stressed out specifically in the pharmaceutical industry, regulatory expectations are more stringent than ever, and may vary in other markets such as food, feed or personal care as well. A strong QMS is no longer optional – it is a key differentiator. At Arxada, we see quality as a strategic pillar that drives every phase of our services ranging from early-stage development to full-scale commercial manufacturing. Our QMS is designed to be proactive, risk-based, and fully integrated into every stage of the manufactured product lifecycle.
From the outset of each customer project, our QA (Quality Assurance) team conducts a comprehensive regulatory assessment, considering the product’s intended use, target markets, and applicable legal frameworks. This ensures that quality requirements are not only met but optimized for the product’s success in its final application. Arxada’s biotechnology manufacturing capabilities are supported by a wide range of certifications, starting with ISO 9001 general quality management guidelines and extending with FSSC 22000 for food production, FAMI-QS for feed production, EFfCI for cosmetic ingredient manufacturing and medical device in accordance with ISO 13485. These certifications are more than badges. They are a testament to our ability to meet diverse regulatory and customer expectations with precision and consistency, reflecting on our versatility and commitment to excellence across multiple industries. The QA team is responsible for interpreting regulatory requirements and implementing them into standard operating procedures (SOPs), ensuring that all aspects of production and quality control align with the above-mentioned international guidelines. To ensure full alignment with our customers’ needs and transparency, we are developing a project-specific Quality Agreement with each customer. This agreement clearly defines roles, responsibilities, and expectations across all quality-related areas such as product specification, audits and inspections, personnel training and qualifications, facility hygiene and operational controls, raw material sourcing and traceability, batch release protocols up to product labeling and packaging standards. This collaborative approach fosters trust, minimizes ambiguity, and ensures that both Arxada and our partners are fully aligned on the quality objectives.
A robust QMS is the backbone of any successful manufacturing organization. An effective QMS ensures seamless operations, continuous improvement, and regulatory compliance. It also facilitates risk management by identifying and mitigating potential quality risks in manufacturing and development. Our QMS encompasses a full suite of quality assurance processes (Figure 1):
Figure 1. Illustration of key QA processes
- Document control and version management: QA team enforces strict document creation (from SOPs to batch records) and control measures to ensure traceability and accountability in every process. Data integrity is another vital component, ensuring that all electronic and paper-based records are accurate, complete, and tamper-proof. Adhering to regulatory guidelines such as FDA’s 21 CFR Part 11 ensures that electronic records and signatures are secure and verifiable.
- Change management, deviation handling, corrective and preventive actions (CAPA): Managing deviations, implementing change control, and executing CAPA are essential to maintain product quality, regulatory compliance, and continuous improvement. Let us point out that one of the key capabilities of our CDMO lies in changeover operations - the critical process of switching between products on the same manufacturing line - where frequent transitions demand precision, discipline, and deep competency from every team member. By defining clear roles, rigorous training, and robust quality systems, we ensure purity and performance of the product and uphold the highest standards in every batch we produce.
- Supplier qualification: Our commitment to quality extends to our entire supply chain. The QA team rigorously evaluates and qualifies suppliers through audits, risk assessments, and quality agreements. This ensures that every raw material, component, and piece of equipment meets our high standards - reducing variability, preventing contamination, and ensuring consistent product performance.
- External and internal audits: We conduct comprehensive internal audits of all departments involved in our biotechnology CDMO operations every two years to proactively identify potential gaps in compliance and quality management. In addition, we undergo external audits by regulatory authorities, customers, and third-party auditors to validate our adherence to global quality standards (Figure 2). Our QA team ensures we are always audit-ready by maintaining current documentation, delivering targeted personnel training, and addressing any findings through a structured CAPA program, driving continuous improvement across the organization.
- Training: People are at the heart of quality. That is why we invest heavily in training and development, ensuring that every team member, from production operators to senior scientists, is well-versed in SOPs and regulatory expectations. We follow a robust training system consisting of several stages such as introductory training, documentation training matrix, on the job training, and legal and compliance training. Regular training sessions, competency assessments, and continuous learning initiatives help us maintain a high-performance culture rooted in quality.
Figure 2. Track record of on-site external audit between 2021-2024
Summary
Through stringent quality management systems, meticulous documentation practices, supplier oversight, and continuous improvement initiatives, our QA team safeguards product integrity and consumer safety, ensuring regulatory compliance, product consistency, and operational excellence.
By embedding quality into every process, every partnership, and every product, we help our customers bring their innovations to life – safely, efficiently, and with confidence.
Our offer
- One-stop-shop CDMO services in the field of industrial biotechnology from early
stage to commercial manufacturing - Facility registered as food manufacturing site at FDA. Holding additional certification
such as cosmetic manufacturing (EFfCI), ISO 9001:2015 and food FSSC
22000/HACCP, FAMI QS, Halal and Kosher - Strong focus on quality and continuous process improvement
- Focus on what matters to you
Authors information
Jiri Sarkady
Senior Quality Manager
Vratislav Stovicek
Business Development Analyst CDMO
Acknowledgments
This work was funded by Arxada AG, Peter Merian-Strasse 80, 4052 Basel, Switzerland.
For further information and/or if you would like Arxada to support your project(s), get in touch with:
Arxada is an industry leader in science-based specialty chemicals that creates innovative chemistry and solutions. Comprised of two business units, Arxada’s Microbial Control Solutions (MCS) business provides more sustainable, science-based solutions that utilize differentiated capabilities in microbiology, actives delivery and formulation chemistry. Its manufacturing and unmatched regulatory expertise meets customer needs in variety of endmarkets, specifically, Professional Hygiene, Home & Personal Care, Paints & Coating, Wood Protection and Material Protection. Arxada’s Nutrition, Care & Environmental (NCE) business serves the needs of our partners in a diverse range of industries including food and feed supplements, aerospace, electronics, renewables, agriculture and industrial, as well as pharma intermediates. Leveraging our strong vertical integration into chemical building blocks, such as ethylene, acetylene, ketene/diketene and HCN, along with our fermentation capabilities and our deep technical expertise, NCE transforms customer needs into high performing solutions. This is achieved through direct product supply or contract development and manufacturing (CDMO). With major sites strategically located in the heart of Europe, Arxada secures its customers’ supply chains, while actively supporting their sustainability efforts.
Headquartered in Basel, Switzerland, the company’s global footprint spans 24 production sites and 14 R&D centers. Its 3,400 associates contribute daily to its overall success.
To learn more about Arxada, please visit: arxada.com and Arxada on LinkedIn
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