A Strategic Response to a Competitive Threat
Discover how we supported a client with a strategic competitive threat response when a competitor’s product launch posed a significant threat to their market position.
Amid the COVID-19 pandemic, Emendo drove a rapid pharma tech transfer of a vaccine drug substance from Phase 2 to Phase 3 manufacturing for a BioTech client. The project was conducted under time pressure, global supply chain disruptions, and pharma regulatory compliance requirements.
THE BACKGROUND
In the midst of the global COVID-19 pandemic, a BioTech company developing a corona vaccine faced the urgent need to transfer their drug substance manufacturing from Phase 2 to Phase 3 scale. This required transferring the entire biologics technology transfer process for the drug substance to an external contract manufacturing organization (CMO), while ensuring uninterrupted regulatory compliance and product quality.
The urgency was driven by fixed regulatory submission deadlines and the global demand for vaccines. Any delay risked not only missing critical milestones but also affecting worldwide access to life-saving vaccines. The client needed a partner with deep expertise in technology transfer in the pharmaceutical industry, who could navigate changing conditions, align stakeholders, and provide structure to a complex, high-stakes transfer.
THE CHALLENGE
Technology transfer in pharma is inherently complex, involving rigorous documentation, risk management, and cross-functional coordination. During the pandemic, these challenges multiplied:
The client needed a partner with deep Tech Transfer expertise and the agility to navigate uncertainty, align stakeholders, and deliver under extraordinary constraints.
OUR APPROACH
We performed a comprehensive market scan to identify CMOs with the required large-scale capabilities and available capacity – a challenging task given pandemic constraint. We developed evaluation criteria focusing on regulatory track record, technical fit, and ability to execute drug product tech transfer activities under accelerated timelines. Through structured evaluations and negotiations, we secured the right partner to deliver at speed and quality.
Building on the Phase 2 process, we developed a full commercial-scale process design. Due to shortages in critical single-use components, our team re-engineered unit operations using alternative resins and filters. This required careful process characterization to demonstrate equivalence while meeting pharma regulatory compliance standards. This step was central to ensuring drug substance scale-up was both technically and regulatorily sound.
Before full-scale production, we executed small-scale adaptation runs to verify process robustness and lot-to-lot consistency. A new working cell bank was created and qualified, providing a stable foundation for biologics technology transfer and reducing risk during scale-up. These runs provided critical data for regulatory documentation and de-risked the Phase 3 batches.
To maintain alignment, we designed a governance model bringing together specialists from manufacturing, QA, RA, and senior management from both Sending (SU) and Receiving units (SU). We held frequent decision forums to address open points immediately, with clear escalation paths. This structured governance ensured efficient documentation flow, supported technology transfer in pharmaceutical industry standards, and enabled informed, fast decision-making.
We applied rigorous planning tools, real-time document tracking, and rapid root cause analysis of deviations. Our close collaboration with the SU and the CMO enabled rapid problem-solving and adaptation at every stage. This agile execution approach allowed the team to keep momentum without compromising quality – essential for successful BioTech technology transfer.
THE RESULTS
Within just five months of signing the CMO agreement, the process was successfully scaled up and the Phase 3 drug substance batch was manufactured and released – a remarkable achievement under pandemic conditions.
Key success parameters included:
By combining structured methods with agile execution, Emendo helped the client achieve what seemed nearly impossible: a large-scale Phase 3 batch delivered at pandemic speed.
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GET IN TOUCH
If you are facing similar challenges with technology transfer in pharma or drug product tech transfer, reach out to Pernille Bonnor, Senior Scientific Consultant at Emendo Research & Development.
Pernille Bonnor
Scientific Senior Consultant