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INFORGE · FORGE · PHASE 4

Your CMC knowledge. Productized.

Process development assistant trained on Inscinstech's v2.2 CMC knowledge base, FDA review documents, and your own historical batches. 21 CFR Part 11-ready.

Enterprise tier only at launch · Private deployment available
mAb-003 Purification Process · v0.3draft
CAPTURE
Protein A
MabSelect · pH 7.4 · DBC 50 g/L
⚠ HMW 0.3%
POLISH
CEX
Capto S · Step gradient
⚠ pI 7.8
VIRAL
UVC inact.
pH 3.5 · 30 min hold
FINAL
TFF
Pellicon 3 · 300 kDa · Buffer A
✓ Audit trail✓ 21 CFR Part 11 signature ready
01THE PROBLEM

CMC knowledge is tribal — and that's the problem.

Every process scientist carries 10 years of habits, preferences, unwritten rules.

When they leave, that knowledge leaves with them. When a new molecule arrives, half the team relearns it.

What if the knowledge stayed?

02THE SOLUTION

A copilot trained on real CMC.

InForge absorbs Inscinstech's CMC v2.2 knowledge base (82+ entries), FDA review docs, and your team's batch records — as a process design copilot.

03CAPABILITIES

Five workflows across the CMC lifecycle.

From the initial process tree to the final IND/NDA document draft.

P0 · CORE

Process development assistant

User describes the molecule + target; Agent recommends a complete process (capture / intermediate / fine / viral inactivation / TFF). Per step: resin / membrane / buffer / parameter ranges / risk flags / alternatives.

TIER · Team / Enterprise
P1

DOE design · execution · analysis

CDSystem DOE module online. statsmodels response surface + next-round recommendation. 21 CFR Part 11 audit trail.

TIER · Team / Enterprise
P2

Impurity attribution + method development

Upload HPLC / MS data; Agent attributes impurity sources (OligoMS approach), recommends characterization methods + limits.

TIER · Enterprise
P3

Risk assessment + ICH Q9 automation

FMEA / Risk Assessment templates + AI fill, outputs IND/NDA report drafts.

TIER · Enterprise
P4

CMC document drafting

Development report · Process description · Specification draft generation, FDA / NMPA style-matched.

TIER · Enterprise
04COMPLIANCE

GxP-ready from day one.

We didn't add compliance as an afterthought. It's a primary engineering constraint.

21 CFR Part 11 compliant electronic records and signatures
Immutable audit trail (Temporal-backed long workflows)
Role-based access control (RBAC) per project, per stage
Customer data never trains the model (contractually guaranteed)
Private deployment available (on customer infrastructure)
IBS integration for accounts, billing, audit
No internet exfiltration in private deployment mode
SOC 2 Type II in progress (Q3 2026)
05DEPLOY YOUR WAY

Four deployment modes. One product.

From cloud SaaS to fully air-gapped private deployment.

SaaS standard

Small / mid biotech teams
LOCATION
inscinstech.ai
DATA
Customer private namespace

SaaS · CN residency

China CMC clients
LOCATION
inscinstech.cn
DATA
Stored in CN · PIPL-aligned

Hybrid

Enterprise clients
LOCATION
Mixed
DATA
Sensitive data on-prem

Fully private

Large pharma · sensitive IP
LOCATION
Customer infrastructure
DATA
All local · no external egress
06INTEGRATION

Same Skills, every tool.

Skills you create or buy work across Claude Code, Cursor, and InForge. agentskills.io-compatible from day one.

agentskills.io is the open standard for Skill interop · InForge is both an authoring surface and an execution surface.

07USE CASES

Three roles. Three force multipliers.

CM
CMC manager · top-20 pharma

InForge cut our P-2 to P-3 transition time from 8 weeks to 3.

Anonymous · v0 placeholder
PS
Senior principal process scientist

It writes the first draft of every dev report I would have written in 2 hours.

Anonymous · v0 placeholder
CR
CRO CMC lead

Our small team punches above its weight because InForge fills in 10 years of experience.

Anonymous · v0 placeholder
08PRICING

InForge at every tier.

Free
— not available on this tier
Pro
— not available on this tier
Team
Core P0 process design · 5 active projects
Enterprise
P0–P4 · unlimited · 21 CFR Part 11 · private deploy · IBS · SLA
Bespoke
Custom Agent · co-development · co-marketing
09SAMPLE OUTPUT

An InForge process design.

app.inscinstech.ai
mAb-003 Purification Process · v0.3draft
CAPTURE
Protein A
MabSelect · pH 7.4 · DBC 50 g/L
⚠ HMW 0.3%
POLISH
CEX
Capto S · Step gradient
⚠ pI 7.8
VIRAL
UVC inact.
pH 3.5 · 30 min hold
FINAL
TFF
Pellicon 3 · 300 kDa · Buffer A
✓ Audit trail✓ 21 CFR Part 11 signature ready
11FAQ

Common questions

In private mode, InForge runs on your infrastructure (Kubernetes / VM). No telemetry. No external model calls unless you configure them. Audit logs stay on-prem.
No — it gives them leverage. Drafts come from InForge; decisions, risk acceptance, and final sign-off come from your team. The audit trail records who approved what.
Inscinstech CMC v2.2 (82+ entries spanning capture, polishing, viral safety, filtration, formulation) plus a public corpus of FDA review documents. Your team's batch records layer on top — never shared.
Yes — IBS is supported natively (accounts / billing / audit). LIMS via standard API integration on Enterprise.
Want to see all 4 modules in one place?Explore the full inscinstech.ai platform

Stop relearning what you already know.

Enterprise tier with private deployment options. Talk to our team.

Request accessTalk to a CMC consultant
InForge · CMC process-development agent | inscinstech.ai