When a Danish biotech company faced a stalled drug product tech transfer involving multiple parties, Emendo stepped in to stabilize the project, unite stakeholders, and steer it toward regulatory and commercial readiness. What had become a fragmented, two-year-delayed transfer with lost knowledge, shifting teams, and no clear direction was rapidly transformed into a structured, collaborative effort aligned with regulatory expectations and commercial timelines.
BEFORE EMENDO STEPPED IN
A Danish biotech company had acquired a new product that required transferring the drug product manufacturing from the original site to a Contract Manufacturing Organization (CMO). Acting as Marketing Authorization Holder (MAH), the company was already two years into a delayed and fragmented pharma tech transfer marked by staff turnover, lost knowledge, and the termination of its previous CMO agreement.
With regulatory timelines at risk and supply chain continuity threatened, the company needed swift intervention to recover the project and secure a new CMO partner. Success would depend on a structured approach to technology transfer in the pharmaceutical industry — and this is where Emendo stepped in.
THE CHALLENGE
Technology transfers in the pharmaceutical industry are rarely linear. Increasingly, these projects involve multiple stakeholders — in this case, the original manufacturer, the acquiring company, and a new CMO. Such three-way setups add layers of complexity and risk to any pharma tech transfer: misaligned governance, fractured communication, and uncertainty about regulatory compliance and overall readiness.
For this client, delays had already eroded trust and momentum. Without decisive action, the company faced further setbacks to regulatory submissions, potential supply chain disruption, and growing reputational risk in the market — highlighting the need for structured pharmaceutical tech transfer planning from the outset.
This situation underscored industry concerns highlighted in WHO Annex 7: Technology Transfer, which stresses the importance of structured communication and knowledge flow between Sending Unit (SU) and Receiving Unit (RU).
OUR APPROACH
The immediate priority was to identify and onboard a new CMO capable of handling aseptic drug product manufacturing at commercial scale. Emendo mobilized subject matter experts to lead a comprehensive technology transfer due diligence process, including:
On-site visits and technical assessments
In-depth contract negotiations
Gap analysis between the SU and RU
By combining technical depth with structured decision-making, Emendo ensured the selected CMO not only met operational requirements for pharmaceutical contract manufacturing but also complied with GMP expectations from WHO Annex 4, laying the foundation for compliant pharmaceutical technology transfer.
With the CMO onboarded, Emendo established a governance framework uniting all three parties — the SU, the biotech company as MAH, and the new CMO. This framework clarified roles, responsibilities, and decision-making pathways, while structured tools and templates strengthened collaboration across teams.
Working hand-in-hand with the client’s SMEs, Emendo designed a comprehensive pharmaceutical technology transfer strategy that:
Defined the sequence of transfer activities
Identified risks and mitigation measures
Ensured alignment with ICH Q10: Pharmaceutical Quality System and ICH Q9: Quality Risk Management
This structured approach restored clarity and control to a complex pharma tech transfer, laying the groundwork for a compliant and efficient execution phase.
Execution involved hands-on project management, on-site oversight at the CMO, and close alignment with regulatory requirements and compliance standards. Emendo coordinated activities including equipment and facility qualification, technical and validation batch production, and preparation of submission-ready documentation.
Every step of the tech transfer and pharmaceutical process validation was guided by international standards, including:
FDA’s Process Validation Guidance
EMA’s Guideline on Process Validation for Finished Products
PDA Technical Report 65: Technology Transfer
By acting as a single point-of-contact with the CMO, Emendo ensured seamless communication, minimized delays, and kept the pharma tech transfer fully aligned with regulatory and quality expectations.
THE RESULTS
Emendo successfully stabilized the stalled pharmaceutical technology transfer and handed it over to an internal project manager with full operational momentum restored. What began as a fragmented, high-risk transfer evolved into a structured and compliant project ready for commercial scale.
Key milestones achieved included:
Three validation batches successfully manufactured, demonstrating process repeatability and robustness at commercial scale
Regulatory submission strategy finalized, with the company prepared for filings in multiple major markets
Knowledge continuity secured across SU, MAH, and CMO, reducing risk of future knowledge gaps
Submission readiness achieved, with only long lead-time analyses and stability studies pending at handover
Through independent expertise, structured governance, and regulatory alignment, Emendo transformed a stalled, high-risk transfer into a coordinated and compliant success story.
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.
Explore how we helped a MedTech client navigate the EU MDR transition by leading a science-driven material reformulation. The result: a fully compliant device that preserved critical product claims, improved performance, and reduced cost of goods – turning regulatory risk into competitive advantage.
A leading medical device manufacturer partnered with Emendo R&D to bring statistical expertise into the development of new product formulations. The goal was to build a rigorous foundation for testing and validation that would inspire confidence in product performance and support regulatory compliance from day one.
Facing a Stalled Tech Transfer?
If you are facing similar challenges with drug product tech transfer or complex multi-party pharmaceutical technology transfer projects, reach out to Pernille Bonnor, Senior Scientific Consultant at Emendo R&D.
Pernille Bonnor
Scientific Senior Consultant
