Technology Transfer Package demo
Draws the process from thaw to fill with every critical parameter, checks each step against the receiving site's equipment, compiles the technology transfer package and writes every gap before the receiving site or CDMO starts. 1:11
What the demo shows
A process transfer solution for CMC teams that compiles the transfer package and its gaps.
Extracts every process parameter, range, class, equipment and method from the development records with its source passage, and draws the process as connected unit operations. When a receiving site is picked, it compares that site's equipment list with every validated range step by step (power per volume, tip speed, kLa, centrifuge g-force and Q/Σ, filters), marks each step fits, adjust or gap, and drafts the risk line for a step that cannot hold its range. It then checks the package against the transfer checklist, writes each gap with evidence, an owner and a proposed action, drafts the package and protocol, and collects both sites' and Quality's signatures.
Transcript
- Technology Transfer Package builds the transfer package for CMC teams, moving a process to a new site.
- The costliest gaps are machines that cannot hold a validated range.
- Here is Veltromap, thaw to fill.
- Lena picks Leiden's 2,000-liter suite.
- The agent compares every step.
- Harvest turns red. Leiden's centrifuge tops out at 8,000 g, not 10.
- The risk line is drafted, a five-hour harvest, risk priority 140.
- Lena adds it to the risk assessment and raises the gap weeks before the run.
- Agents then build the package.
- 46 checks, every gap with an owner.
- Packages built in days, each gap found before a batch.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.