Technology Transfer & CDMO/CRO Management
We ensure seamless transitions from laboratory scale to pre-clinical to pilot and commercial manufacture.
Technology Transfer Packages
Developing detailed documentation including acceptable parameter ranges, critical material attributes, and known failure modes to enable reliable reproduction at new sites.
CDMO Selection & Oversight
Defining technical requirements, evaluating proposals on a consistent commercial basis, and providing technical oversight during transfer execution.
Scale-up Risk Assessment
Identifying process parameters likely to behave differently at larger scales and designing experiments to characterize this behavior before transfer.
CRO/ CDMO Management
We provide insights for reliable partners for enzymes, caps, nucleotides, mRNA, plasmid manufacturers to ensure long-term commercial viability. We also partner directly with you to help manage external research or manufacturing relationships and guide on SoWs, RFPs, milestone tracking, timeline management, tech transfer and more.
Let us help maximize your impact.
Smart molecule design is critical for execution!
Our strategy is built for robustness, success and speed. The correct design strategy saves time and decreases wet lab experiment design space, enables faster synthesis and scale up optimization to accelerate development freeing up your resources. Reduction of royalty and licensing costs and avoid common pitfalls. Reduced COGs and longer-term strategy baked in to ensure compliance with regulatory requirements.
Frequently Asked Questions
How do you ensure that a manufacturing process is reliably reproduced at a new facility?
We create comprehensive Technology Transfer Packages that detail acceptable parameter ranges, critical material attributes, and known failure modes to enable seamless transitions from laboratory scale all the way to commercial manufacture.
How do you help select the right Contract Development and Manufacturing Organization (CDMO)?
We define precise technical requirements, evaluate CDMO proposals on a consistent commercial basis, and provide dedicated technical oversight throughout the execution of the transfer.
How do you mitigate the risks associated with scaling up production?
We conduct Scale-up Risk Assessments to identify specific process parameters that are likely to behave differently at larger volumes. We then design targeted experiments to characterize this behavior before the technology transfer takes place.
What support do you offer for managing ongoing CDMO or CRO relationships?
We partner directly with you to manage external research and manufacturing relationships by guiding the development of Statements of Work (SoWs) and Requests for Proposals (RFPs), tracking milestones, and managing timelines. We also provide insights into reliable manufacturing partners for essential components—like enzymes, caps, nucleotides, mRNA, and plasmids—to ensure your long-term commercial viability.