Portfolio · Project 10

Alexander CHERNOV

Principal Engineer · Agentic AI & scientific data systems

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10

Batch records as typed programs

2025 – present · AstraZeneca

Approval is a node, not a convention — typed ports, only same-typed ones connect, and human approval sits inside the grammar.

A designer for master batch records (MBR) that executes them as electronic batch records (EBR), in Rust and React, with a no-backend browser build for places that will not host a server. One spine underlies every recipe — source, pre-process, reason, approve, sink — and the records live in version control, so review, promotion and rollback are the ordinary git ones.

A platform mAb downstream purification MBR, executed in the browser build: nine unit operations joined to their in-process controls, checked against five MBR limits, then held at a QA approval node. The executed record on the right flags one step — viral-inactivation hold above its 120-minute limit. Illustrative batch values; limits follow published platform ranges.
A platform mAb downstream purification MBR, executed in the browser build: nine unit operations joined to their in-process controls, checked against five MBR limits, then held at a QA approval node. The executed record on the right flags one step — viral-inactivation hold above its 120-minute limit. Illustrative batch values; limits follow published platform ranges.

Batch records are authored as documents and executed as programs, and the gap between the two is where validation effort goes. This is a visual builder in Rust and React where the MBR is authored as a graph and every run of it yields the EBR, including a browser-only build with no backend at all, so the authoring surface works where a server cannot be deployed.

The grammar is a visual pipeline with a type system: boxes are nodes, arrows are typed edges — rows, table, scalar, signal — and only same-typed ports may be wired. Every recipe instantiates one spine: source, pre-process, reason (AI), approve (human), sink. Human approval is a first-class node in the grammar rather than a workflow convention bolted on afterwards — the same conclusion as the pooling gate above, reached independently in a different domain. Records are governed in git: review, environment promotion, rollback.

Underneath it, twenty years back to pharmaceutical manufacturing execution systems in validated GxP environments.

References

  1. IEC (1997). IEC 61512-1: Batch control — Part 1: Models and terminology (ISA-88). International standard. webstore.iec.ch
  2. U.S. FDA. 21 CFR Part 11: Electronic records; electronic signatures. Code of Federal Regulations. ecfr.gov
  3. Kelley (2009). Industrialization of mAb production technology: The bioprocessing industry at a crossroads. mAbs 1(5), 443–452. doi:10.4161/mabs.1.5.9448

No public URL — internal system.