BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
The biopharmaceutical industry continues to develop advanced best practice manufacturing processes, systems, technologies and facilities. However, we experience varying degrees of understanding and confidence across manufacturers and regulators. This can lead to uncertainty that proposed improvements will be accepted and successfully implemented in an aligned way. Therefore, to avoid perceived issues, best practice can end up being diluted, or solutions over-engineered. Ultimately, innovation and improvement is slowed, presenting a challenge to realize potential benefits such as speed to market, supply assurance and cost.
To address this, the BioPhorum Regulatory Governance Team recommends, facilitates and supports an ongoing platform of informal dialogue with agencies, offering industry views and listening to wider agency perspectives, prior to implementation. We are well placed to share industry positions on priority topics with agencies and solicit feedback by developing contacts with regulators and associated standard organizations, across the regulatory networks of member companies.
The goal of the team is to make appropriate regulatory agency connections, increase mutual understanding of key positions and challenges in implementing new biomanufacturing practices. The team is well positioned and resourced through pooled company intelligence of how different agencies are approaching key regulatory topics and challenges. This includes opportunities to share latest thinking with agencies with the desire to increase positive submission and inspection outcomes for both industry and regulators.
The Regulatory Governance Team consists of 38 representatives from 26 biopharma manufacturing and supply partner companies. The representatives are experienced professionals with extensive regulatory background and extended networks within their companies, other industry groups and with regulators. Membership of the regulatory team is available to representatives from company members of Phorums with appropriate Regulatory background and experience.