Meet our challenge solver - Fernanda Macarini

Our market knowledge and technical know-how enabled us to support the customer’s needs during the R&D process and the analytical qualification of our products.
Challenge

In the pharma market, excipients are integral to our portfolio. That’s why when one of our suppliers discontinued the production of a particular excipient due to strategic portfolio considerations, our customers in LATAM were faced with quite a predicament. The available alternative had to be significantly altered to be applied in their pharmaceutical products. How did we leverage our market knowledge and technical know-how to tailor the excipient to customers’ needs so they would not face potential disruptions in their production and jeopardize sales?

Solution

Our ability to deliver distribution solutions globally is not only because of our state-of-the-art infrastructure but also because of our exceptionally talented and capable colleagues. We understood that a new excipient meant implementing a thorough quality assessment and control process with formal approval from the official regulatory authority. However, initial product analyses showed unfavorable results. The excipient simply did not meet the conditions stipulated for this particular customer’s end product yet. 

Building on our long-term experience in the pharma market and proficiency in technical development, we worked diligently with the customer’s quality control team and tested the excipient in end-product applications. Managing the key parameters of the starch-based excipient – solubility, density, and viscosity – was crucial to ensuring the performance of the end product. We supported the analytical team in the preparation of samples for the validation process, so that they could approve and implement the specification of this new material, without impacting the formulation of the final product. Despite the initial setbacks, we successfully completed the homologation process for the excipient – testing and validating as per the stringent quality standards – preventing potential interruptions in the customer’s pharmaceutical production plant. 

Fernanda Macarini
Product Development Specialist, Pharma, Caldic LATAM "We successfully ensured the continuity of production at our customer’s site by tailoring an alternate excipient to exact specifications and acquiring the necessary regulatory approvals in time by capitalizing on our pharma expertise."

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