The biopharmaceutical sector is expanding twice as fast as traditional drug manufacturing, and currently accounts for 20 percent of the pharmaceutical industry.1,2 Biotechnology companies are therefore under increasing pressure to maintain a rapid pace of development, while providing trackable documentation to comply with rigorous regulatory standards. This pressure highlights the importance of a cohesive, company-wide approach to quality management.
In this blog, Nicole Barnes, Team Leader in Quality Assurance and Compliance, underscores the foundational role that state-of-the-art quality management software plays in optimizing operational efficiency and satisfying regulatory requirements. She will also take us through Ingenza’s dynamic new partnership with Opvia, a leading provider of digital quality management systems (QMS).
Pursuing next generation quality assurance
I have the pleasure of being one of Ingenza’s longest-serving team members, and have contributed to the evolution of the company’s QMS over the years. Harnessing and coordinating our collective experience in different aspects of quality assurance and compliance has resulted in a robust quality infrastructure that I’m personally very proud of. Ingenza’s QMS is based on ISO 9001 and also complies with international good manufacturing practices (GMP) for early stage development projects. Our demonstrably high quality standards have allowed us to consistently deliver early stage projects in the pharmaceuticals sector, an exciting growth area of our business progression. Ingenza’s QMS closely adheres to the European Union’s guidelines for the manufacture of biotechnology and biological products, the ICH Q10 Pharmaceutical quality system – Scientific guideline,3 confirming our competency for the development and manufacture of novel active pharmaceutical ingredients (APIs) for use in GLP toxicology studies.
Despite these achievements, we continuously strive to improve our operations, exemplified by our commitment to constantly streamlining Ingenza’s quality management processes for enhanced operational precision and efficiency across our R&D and production divisions. Our ongoing QMS optimisation supports microbial strain and mammalian cell line engineering, protein production, upstream fermentation, downstream bioprocess development and analytical operations. In combination with our enhanced data management and security processes, we provide our customers with the protection and confidence necessary to underpin and drive their growth and service expansion. Consistent with these initiatives, we are transitioning to a pre-validated electronic QMS (eQMS) that will automate our quality assurance and control through more efficient document, data, audit and training management. This will further enhance our operational efficiency, reduce compliance risks, improve transparency and scale our business.
Accelerating transformation with a digital QMS
Following extensive research and comparison of several eQMS providers we selected, Opvia – a provider of tailored software solutions for R&D, manufacturing and quality control. The modularity, adaptability and flexibility of Opvia’s offering made it particularly suitable for a versatile life sciences companies like Ingenza. Competing products tended to include redundant features that represented an extra administrative and technical burden to our team, without providing any real benefit to our operations. In addition, we found off-the-shelf eQMS programs developed for larger organisations to be less adaptable, whereas the ability to customise the software to our needs gave Opvia an edge.
Conversations with Opvia’s technical specialists as well as positive references convinced us that the platform would suitably integrate into and manage Ingenza’s quality management practices. We entered into the partnership in November 2023, working with Opvia’s software developers to implement the eQMS platform across Ingenza. We have been delighted with the in-person training from the Opvia team, and have found the software very intuitive and easy to use. The software developers have been highly responsive, onboarding our feedback and requests to optimise the software to our requirements.
Ingenza is already enjoying the advantages of streamlined quality processes, centralised data management, automated workflows and data-driven decision making offered by the system. We can more easily share data and documents internally – with full control over access and editing – as well as record and track all actions, creating an unbreakable chain of custody that can be audited and traced back to the source. The platform brings a level of automation that reduces the likelihood of human error, improves consistency and integrity, and frees up our staff to perform other tasks. This in turn increases our productivity and cost effectiveness, underpinning an even higher standard in the products and services we provide to our customers.
World-class technology for future-preparedness
Implementation of our new eQMS is well underway, and we are excited about the full benefits the Opvia platform will bring to Ingenza’s diverse workflows, including electronic laboratory notebook and electronic batch manufacturing records. Ingenza’s future-ready eQMS is a critical company asset that demonstrates our unswerving commitment to quality, and it will enable us to meet and exceed the increasingly strict quality standards demanded by the biotechnology industry for years to come.
- Otto R, Santagostino A, Schrader U. Rapid growth in biopharma: Challenges and opportunities. McKinsey & Company . Published online December 1, 2014.
- Mordor Intelligence. Biopharmaceutical Industry Size & Share Analysis – Growth Trends & Forecasts (2024 – 2029).; 2024. Accessed April 17, 2024. https://www.mordorintelligence.com/industry-reports/global-biopharmaceuticals-market-industry
- European Medicines Agency. ICH Q10 Pharmaceutical Quality System – Scientific Guideline. https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline; 2008.