Executive Summary

API Manufacturing Facility S, a key supplier for the innovative and promising brand-name antidepressant drug C, faced significant challenges in optimizing production processes. Thanks to Unibest’s expertise, the Facility gained essential improvements in yield and conversion rates and secured a stable supply of crucial intermediate C3, paving the way for FDA approval and the successful launch of drug C.

Customer Profile

API Manufacturing Facility S is a vital link in the production chain of drug C, an innovative antidepressant demonstrating impressive clinical effectiveness with fewer side effects than comparable drugs. To assist FDA approval, Facility S was on a mission to find a reliable source for intermediate C3 to ensure the ongoing commercial supply.

Challenges

In their mission, Facility S encountered several hurdles:

Poor yield and conversation rate from C4 to C3, accompanied with significant refinement loss in transforming C3 to keep single impurities under 0.1%, which would result in higher cost of material

Necessity to secure a GMP system compliant supplier for C3 to facilitate FDA approvals

Forecasted requirement for the tonnes supply of C3

Challenges handling dangerous reactions (nitration) during synthesis

Environmental pollution during production was a serious concern

Solution

In response to this complex challenge, Unibest implemented an intricate plan:

Unibest conducted thorough due diligence and strategically distributed the C3 production process between Unibest’s Shanghai facility and other factories based on their competitive advantages

An industrial expert panel was created to guide the R&D and manufacturing process and ensure successful project delivery

Implementation

Unibest’s Shanghai facility was tasked with resolving the refinement loss issue during R&D

A GMP-compliant CDMO factory, which later became a strategic partner, took the responsibility for scaling up manufacturing C3 from C4, maintaining high-quality output

To ensure safe, environmentally-conscious production, dangerous reactions and pollution were mitigated by introducing flow chemistry at a CMO factory

Results

Recognizing the under-diagnosis and under-treatment of depressive disorders as a public health issue, Unibest prioritized adequate supply for production. This was achieved with consistent and GMP grade supply of intermediate C3, leading to FDA's approval of Drug C in 201X. Success in this project cultivated stronger relationships among suppliers, the customer, and API Manufacturing Facility S leading to future collaborations.

Testimonial

"Facing stringent procurement needs and high standards for our innovative antidepressant drug, we had to ensure a stable supply of intermediate C3. With Unibest’s help, not only did we optimize our production process, but we also were able to secure long-lasting, reliable relationships with our suppliers. This success has not only helped our bottom line but more importantly, it's supporting the mental health of countless individuals." - Representative of API Manufacturing Facility S

Call To Action

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