Practical Tips for a Successful Partnership for Raw and Ancillary Materials
By Felicity Thomas
The success of an advanced therapy development program can be impacted by the raw and ancillary materials supply chains. A relationship between materials suppliers and developers is, therefore, of great import. As such, Pharmaceutical Technology asked Claudia Zylberberg, CEO of Akron Biotechnology, and Bernd Leistler, vice-president production, CellGenix, to provide some practical tips for a successful partnership.
“The relationship between ancillary materials suppliers and advanced therapy developers should be more intimate than an arms-length relationship,” explained Zylberberg. “There needs to be a close partnership between the two in order to create opportunities for improvement on both sides.”
“It is important to build a trustful partnership with your supplier and share forecasting information to prevent supply issues,” said Leistler.
“The need for data and documentation on the ancillary materials employed in a developer’s manufacturing process is increasing, which requires greater openness and dialogue between parties,” added Zylberberg. “It is important to maintain an open dialogue, ensuring that issues are addressed early on, and both parties work together to meet common goals.”
Security of supply
“Security of supply is a critical issue for advanced therapy developers. It is imperative to ensure that your ancillary materials provider can scale alongside you and provide the regulatory support you need,” emphasized Zylberberg. “This is a two-way street, as developers must provide accurate forecasts and clear directives regarding testing and documentation requirements to ensure timely delivery and support.”
“In this regard, it is advisable to set up supply and quality agreements for critical raw and ancillary materials,” confirmed Leistler.