Built for process development groups — cell therapy, mRNA / LNP, oligonucleotide, bioconjugate, AAV. Draft your process as a graph, capture every lot, and use AI to help you do it — so you never lose a parameter, or the reason a run drifted, even when the scientist who ran it has moved on.
You’re running CAR-T, LNP, AOC, or AAV development with three to fifteen PD scientists. Every run is novel. Every lot matters. And the institutional memory of how each process actually behaves is sitting on clipboards, in SharePoint folders, and in the head of the scientist who left last month. Batchrite is the fix.
Runs are logged on clipboards, transcribed at 18:00, and re-keyed into a SharePoint spreadsheet at 22:00. By the time CMC asks why lot 6 looked different, the answer is gone.
Real PD processes branch, loop, and parallelize. Linear step-lists flatten the truth, then patch the model with spreadsheets and tribal knowledge that walks out the door with every new hire.
Generative models can draft a 200-page legal brief, but the PD scientist is still pasting prompts into a chat window and copying answers back into a paper form headed for a three-ring binder.
From the graph-based process designer to AI-assisted authoring, vision capture, and paper-record import, every primitive is purpose-built for how process development groups actually run novel processes today.
Drag-and-drop unit operations onto a canvas. Assign roles, bind equipment slots, branch logic, parametrize every step. Built on SvelteFlow so the canvas feels as fast as Figma.
Processes are templates. Each run snapshots them at execution time and tracks every deviation against the source. Refactor a template and your historical runs stay intact — the process memory survives turnover.
Type a prompt. Get unit operations, parameters, swimlanes, and IPCs. Iterate in chat until it’s right, then commit to a new process version. The whole graph stays editable in the designer.
Ask the agent to find a process from the public literature. It searches OpenWetWare, returns candidates with full attribution under CC BY-SA 3.0, and — only after you approve — drafts a Batchrite process from the source.
No hallucinated steps slip into your library. Every imported process carries a citation trail.
Batchrite gives PD groups what paper records and SharePoint can’t: a single, queryable history of every run you’ve done. Lightweight review-and-lock workflow (PD scientist → process lead → head of PD) with hand-drawn e-signatures. Immutable audit trail. Reason-for-change on edits. Built for PD — not bolted on as commercial GMP overhead.
Upload a filled-in paper batch record — PDF, DOCX, or image. The AI extracts step status, timestamps, parameter values, signatures, and notes; maps fields to your digital run; and backfills the execution record — so your historical lots become searchable process memory.
Tap the camera during a run to capture a balance display, gauge, plate, gel, or handwritten log. The vision model parses the image, lifts numeric readings, lot codes, and observations, and proposes structured fields against the current step. You approve before anything lands in the batch record.
The seven headline features get the spotlight. The rest of the product is everything you’d expect from a PD-focused batch-record system — without the four-month implementation cycle that commercial MES vendors quote you.
No proprietary file formats. No “contact sales” to get an export. No retention games when you cancel. Every protocol, run, batch record, signature, photo, and audit-log entry is yours — available in open formats, on demand, for as long as you have an account.
Pull the entire project — protocols, runs, batch records, signatures, attachments — as a single archive. Or per-run as Excel, CSV, or PDF.
Excel, CSV, PDF, and image files — the formats your team already uses. Walk in with paper, walk out with data you can actually open and read — and walk away whenever you want.
Send every run to your team’s own data systems automatically, and pull anything back out on demand. Get a notification on every sign-off. Your systems stay your systems.
Your data is kept separate from every other customer’s. AI features work over your data, for your queries, only. Disable them entirely if your compliance posture requires it — the product still works.
If you ever decide to leave, we’ll get you and your data out the door cleanly. 90-day post-cancellation access. Full archive on request. No exit fees, no negotiation, no friction.
Read the export terms →Batchrite’s first cohort is 15 PD groups in the San Diego biotech cluster — cell & gene, mRNA, oligo, bioconjugate, AAV. There’s no self-serve signup. Every partner starts with a 30-minute conversation so we understand your modality and bench before you ever touch the product.
Batchrite is built for the work you’re doing before the GMP shadow falls — PD, late-stage research, IND-enabling development. We don’t claim 21 CFR Part 11 compliance and we don’t pretend to be a GxP MES. Here’s what we do ship — the traceability and process-memory primitives a PD group actually needs — and what we don’t pretend to.
Scientist → process lead → head of PD. Each step gates the next; post-lock edits require a fresh signature and reason. Right-sized for PD — not GMP overhead.
Initials and full signature, bound to every consequential review event. Stored as immutable artifacts on the audit trail.
Every mutation logged with actor, timestamp, before/after. Append-only. Tamper-evident hashes per entry — so process memory survives turnover and CMC handoff.
Post-lock edits require a typed justification and a fresh signature. Locked records can’t be silently mutated.
Every lot, reagent, instrument, and operator threaded through a queryable history. When CMC asks why lot 6 looked different, you have the answer in seconds.
One-click archive of the entire project in open formats (Excel, CSV, PDF). Per-run exports, or connect Batchrite to your own data systems. Your data, on demand.
Each customer’s data is kept logically separate. Your data is never used to train shared models. A dedicated, single-customer deployment is available for design partners.
SAML SSO and SCIM provisioning with Okta, Entra, and Google Workspace. Targeting Q3 2026 with design partners.
Data is encrypted at rest today. The option to bring your own encryption keys (AWS, GCP) is rolling out to design partners through Q3.
We don’t claim Part 11 compliance, GLP validation, or commercial-GMP fitness — and we’ll tell your QA group as much in writing. Plan to move to a validated MES (Tulip, MasterControl, Veeva) once your process leaves PD. Batchrite is built to hand off cleanly when that day comes.
Founding partners vote on what jumps the queue. Here’s what’s landing first.
Ask the chat agent: “Analyze my last 12 LNP runs and tell me what’s driving % encapsulation.”
N/P ratio (p = 0.003) and aqueous flow rate (p = 0.01) are your significant factors. Encapsulation peaks at N/P 6.2 / 12.5 mL/min. Want me to draft a new process version with these parameters?
→ replaces JMP / Design-Expert for the 80% case
One click turns a locked process into a tech-transfer package — mapped to your CDMO’s format, or your own custom SOP / batch-record template.
→ no more rebuilding the record by hand for transfer
Connect Batchrite to the AI agents you already run. Query runs, draft processes, and log results — without ever opening the UI.
Logged OD₆₀₀ = 0.82 to run BR-2026-0184 and flagged the 14-min foam event. Drafted next week’s LNP run from the v3 template — ready for your review.
→ the bench talks to Batchrite, no tab-switching
Working with an early product is a different kind of decision than buying a mature one. Here’s what process development groups typically ask before signing on.
No — and on purpose. Batchrite is built for process development work, which is pre-GMP and pre-Part 11 by design. We don’t make Part 11 compliance claims and we don’t pretend the product is fit for commercial GMP manufacturing. We’ll tell your QA group as much in writing.
What we do ship: a lightweight scientist → process lead → head of PD review-and-lock flow, hand-drawn e-signatures, an immutable audit trail, and reason-for-change capture. That’s the right floor for PD — enough traceability to defend a process to CMC, without the GxP overhead that would slow you down before you have a clinical candidate.
When your process moves into GMP, we’ll hand off cleanly to a validated MES (Tulip, MasterControl, Veeva) with a full export of the development history.
Those are ELNs and LIMSs. They’re great at structured inventory, sample tracking, and the discovery side of the house. They were not built to be a batch record system for a complex, multi-step PD process — which is why every PD group we’ve talked to runs Benchling alongside a stack of paper or SharePoint spreadsheets.
Batchrite is the digital batch record layer for that PD process — graph-based, modality-aware templates, AI-assisted authoring. It plugs in next to your ELN; it doesn’t replace it. Several pilot members run both.
That’s exactly who this is for. The pilot is sized for cell & gene, mRNA / LNP, oligo, bioconjugate, and AAV PD groups with 3–15 active scientists, pre-Phase 1 or Phase 1, currently on paper batch records or SharePoint / Excel hybrids. Series A or B, 20–80 employees is the sweet spot.
If you’re still 3 people in an incubator bay we’ll still talk — we just won’t pretend you need the whole product yet.
Your data stays your data — full stop. You can export the entire project as a single archive (with all your files and attachments) at any point, or stream it continuously to your own data systems. No “contact sales” gate, no proprietary format, no exit fees. Done from settings in two clicks.
If you cancel, we keep your project accessible for 90 days so you can pull anything you missed. If you decide not to continue at GA, we’ll give you a 60-day grace period to migrate on top of that.
The assistant works only over your own data — your processes, templates, run history. Your proprietary information is never used to train shared models, and is only ever read to answer your own questions.
For the OpenWetWare integration, the search runs against the public corpus and returns candidates for your approval. We will not draft Batchrite processes from those candidates until you click Approve & import.
You can disable the AI features entirely if your security posture requires it. The product works without them.
We’ll publish GA pricing 30 days before the pilot ends. Expect it to be priced for Series A/B PD groups — not for commercial manufacturing.
Pilot cohort members get grandfathered rates locked for 24 months after GA — below whatever public pricing turns out to be.
Because we’ve spent the first year of the company on the product, not the badge. SOC 2 Type II is on the roadmap for late 2026 — sequenced after GA so the controls we attest to are the ones actually in production.
In the meantime, we’ll walk your security team through our architecture and answer any questionnaire. The underlying controls (data isolation between customers, encryption at rest, an immutable audit trail, and role-based permissions) are already shipped.
Honestly: today, mostly by hand. PD scientists log readings and observations directly into Batchrite at the bench, or upload exports (CSVs, PDFs, photos of an instrument display) and let the AI structure them. Paper-record import handles the long tail of historical lots.
We don’t ship native instrument integrations yet — it’s the most common cohort request and we’d rather wait until we know which two or three instruments our pilot members actually live on, then build those adapters properly. You can connect Batchrite to your own systems for anything you want to wire up yourself in the meantime.
Book a 30-minute call to start. If you’re inside the 30-minute SD drive zone we’ll come to you with two coffees. Otherwise, we’ll meet over video.