The importance of quality and consistency from a CDMO for aseptic manufacture.
Susan Swan, Head of Quality, Symbiosis Pharmaceutical Services
The demand for advanced parenteral manufacturing support from Contract Development and Manufacturing Organisations (CDMOs) continues to rise due, in part, to factors such as a growing pipeline of biologics like complex oncology and vaccine products. Due to the requirement for special procedures and equipment for fill-finish operations that ensure product quality and safety, the level of technology to support these exacting specifications in production is ever-increasing. Biologics represents the majority of top-selling drugs and the fastest-growing pharmaceutical segment. The Biologics space is supported by the evolving capabilities and strategic compatibility to service this segments demands for injectable medications.
Bioavailability, the proportion of a drug substance entering the circulation following administration, is a critical parameter. Parenteral administration enables direct administration of drug substances ensuring optimal bioavailability. Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices.
Faced with the growing demand, expectations for advanced technological production solutions and increased complexity of drug substances and ever more regulatory scrutiny – expectations have never been as high from innovators. Add to this, the requirement for quick access to manufacturing slots and abbreviated development timelines, then CDMOs must develop flexible and innovative approaches to manufacturing efficiencies to ensure all expectations are met without compromising quality.
Quality at the root of CMDO solutions
Due to the complexity of the environment of aseptic parenteral product manufacturing, the best chance for success is to implement a culture of quality where effective quality systems are systemic within the business. A CMDO that designs quality into the parenteral manufacturing process from the start, and reinforces this with a process for continuous improvement, is the embodiment of a quality culture. At Symbiosis, we utilise a collaborative and integrated project management process that brings together cross-functional teams to provide the highest standards of quality to our customers, while helping to minimise potential problems that could result in delays in getting products to market.
A central component of our quality strategy is the importance and preparation for constant inspection readiness. Supporting products released for use across several geographic regions, we adhere to multiple regulatory requirements for compliance. This is constantly assessed in our regular self-inspection programs, as well as frequent client audits, meaning we are perpetually ensuring a sustained state of regulatory compliance. We identify, resolve, and document any continuous improvement opportunities that arise, and that information is always available during audits. Our collaborative approach with our clients for a quality strategy combined with our strong quality culture helps facilitate that inspection readiness.
Visibility enabling quality metrics
‘You can’t manage what you don’t measure’ is the old adage and this rings true when it comes to monitoring quality metrics. Creating key quality metrics allows for the identification of adverse trends that enable action to be taken before they become critical quality issues. Symbiosis has developed metrics that analyses our performance by monitoring on a weekly, monthly and annual review frequency. This enables our organisation to demonstrate that the quality strategy is verified and allows the quality function to work with all departments to ensure continuous improvement is being sustained. We routinely review all relevant metrics to ensure they are current and reflective of the required regulatory expectations.
Furthermore, the organisation has made a significant investment in technology quality systems for data alignment, quality systems for training, tracking and document management which has established consistency across all activities. These technologies support our expert teams, which help the sites set goals for their various activities (research, quality, etc.) to address important issues consistently.
Additionally, to ensure a mutual understanding of quality requirements, we have routine meetings, at a frequency set by the client, in which the quality teams from both companies collaborate. These meetings are designed to review the adherence to the quality agreement and raise points of relevance supporting the release of the medicinal products Symbiosis produced. This governance structure creates a clear alignment between both organisations and increased opportunity to respond to challenges promptly.
The final, but probably most important factor in quality and consistency, is found in the regulatory history of a CDMO. To facilitate this, we have transparency on our commitment to quality we typically support evaluation of the last five years’ worth of inspections. We aim to share our regulatory inspections with our clients and seek their support where any product-specific inspection is performed. Our quality history from a regulatory standpoint is exceptional.
Building quality into our future
A strong quality culture and effective quality systems are established in our day-to-day operations and we use this as the foundation for future expansion plans. The quality culture we have developed feeds into all departments via the management structure. The future is bright at Symbiosis and expansion plans don’t stop with the recent announcement of the new analytical testing labs. Further expansion is on the horizon and will be underpinned by a commitment to quality. Consistency in our quality approach for the introduction of any new capacity and capabilities would be a focus for our organisational development. Key to this will be our quality culture adapting to ensure we hit the ground running with the same high standard of quality excellence.