CDMO Customer - Sourcing Project

This case study details a successful sourcing task undertaken by Matrix Fine Chemicals (Matrix Fine Chemicals) in Flums, Switzerland, for a larger CDMO, located in Switzerland. The company required a complex starting material for their pilot plant. This case highlights Matrix Fine Chemicals's expertise in sourcing hard to find chemical meeting stringent a strict impurity profile.

Client Background

The customer is a large Swiss multinational CDMO for the pharmaceutical, biotechnology and nutrition sectors. They were looking for a starting material that was commercially available but not with the impurity profile that the customer was looking for. The company sought a reliable and experienced partner to source the product with the pre-defined impurity profile.

Challenges

The company presented Matrix Fine Chemicals with the following key challenges:

• Existing product: The target raw material was commercially available but the required quantity by the customer did not justify an adaptation of the specification.
• Strict Quality Requirements: The raw material needed to meet stringent impurity specifications of 8 impurities at very low level.

Matrix Fine Chemicals' Approach

Matrix Fine Chemicals adopted a systematic search for existing producers but learned that the current suppliers were not able to meet the impurity profile set up by the customer.

• Initial Consultation: Matrix Fine Chemicals's experienced team held detailed discussions with the customer to fully understand the quality attributes and project timelines.
• Sourcing activities: Matrix Fine Chemicals initiated a systematic search for existing manufacturers but found that the current suppliers were unable to meet the impurity profile specified by the customer because the required quantities were too small for them.
• Analytical Method Exchange: Thanks to a three-way non-disclosure agreement, we were able to share the customer's test method and conditions with our supplier. The manufacturer adapted the test method to its quality control requirements.
• Quality Control and Documentation: Comprehensive quality control testing was performed on the raw material to ensure it met all predefined specifications and especially to meet the required impurity profile. A detailed analytical report, including all relevant data (NMR, HPLC, MS, etc.), and a Certificate of Analysis (CoA) were provided to the client. Full batch documentation was maintained for traceability and regulatory compliance.
• Communication and Collaboration: Throughout the project, Matrix Fine Chemicals maintained open and transparent communication with the customer, providing regular progress updates, discussing any challenges encountered, and collaboratively finding solutions.

Results and Outcomes

Matrix Fine Chemicals successfully delivered the key starting material to the customer within the agreed-upon timeline and meeting the required quality specifications. Key achievements included:

• Achievement of High Purity and impurity profile: The delivered raw material met the customer's stringent purity requirements, including impurity profile, as confirmed by comprehensive analytical data.
• Timely Delivery: Matrix Fine Chemicals adhered to the agreed-upon timeline and the customer’s project could start on time.
• Strong Collaboration and Communication: The collaborative partnership between Matrix Fine Chemicals and the client facilitated a smooth and efficient project execution.

Client Testimonial

Solution

This case study demonstrates Matrix Fine Chemicals's capabilities as a reliable and highly skilled partner for sourcing hard to find chemicals, particularly those that are challenging in regard of complexity in the structure or strict requirements in specifications. Matrix Fine Chemicals's integrated approach and a strong focus on customer collaboration, enabled us to successfully deliver the required product for the customer. This project highlights Matrix Fine Chemicals's commitment to providing tailored solutions and exceeding client expectations in the fine chemicals industry.