BiOS

Biotech Operations & Systems

Make innovative medicines cheaper, faster, and right first time.

Working tools for COGS, line balance, readiness, and scale-up — built around how you actually operate. Antibodies, cell therapy, viral vector, and small-molecule API. Not a generic checklist, and not only a one-shot PDF.

First paid pass: $4,500 Operational Scale-Up Assessment · ~10 business days

Explore tools Why BiOS exists

Where scale-up usually breaks — between functions, not inside one

Process

→

Materials

→

Equipment

→

Quality

→

Data

→

People

Process scale-up → material demand → supplier exposure → release specs → inventory → scheduling. BiOS connects the chain so leadership can decide.

What BiOS offers

Tools and assessments for the plants that make medicine.

COGS analysis, line balance, readiness, and a fixed-fee scale-up assessment. Built for operators who need decisions this quarter — not another generic maturity score.

Antibodies · cell therapy · viral vector · small-molecule API

Paid first pass · $4,500Operational Scale-Up AssessmentA working decision tool customized to your plant: ranked gaps, a current→future map, and a Now/Next/Later freeze. Not only a PDF.Antibodies · cell therapy · viral vector · small-molecule API Hosted tool · cell therapy worked exampleCOGS analysisCost of goods first. Walk a full batch bill, compare plant positions, and build a step-change plan. The live example is autologous cell therapy; the same method applies to other modalities.Cell therapy today · same COGS method for antibodies, vector, and API Hosted preview · antibody BDS sampleCOGS stack previewHow BiOS stacks materials, labor, utilities, and overhead into contribution and fully loaded cost. Sample numbers are mAb BDS; the stack travels to other products.Antibodies today · same stack for cell therapy, vector, and API Free game · live on this siteLine Balance LabMatch upstream, downstream, and QC so campaigns clear release. Same craft as real scale-up, across modalities.Antibodies · cell therapy · viral vector · small-molecule API Free diagnosticReadiness scorecardA short cross-functional read on where scale-up pressure will show up first — capacity, release, materials, ownership.Antibodies · cell therapy · viral vector · small-molecule API

See all tools Why BiOS exists

Free game · antibodies, cell therapy, vector, API

Line Balance Lab — match the plant so it flows

Cartoon bioreactors, purification lines, and QC benches. Level the load across people and capacity so campaigns clear release — the same craft whether you make antibodies, cell therapy, viral vector, or small-molecule API.

Play Line Balance Lab Or take the scorecard

COGS analysis · cell therapy worked example

Cost of goods first. Cell therapy is the live application.

A working COGS model of one autologous batch: typical commercial lot, mature scale, and best-in-class technology — then a step-change planner for ambitious levers. The same method applies when the product is an antibody, a viral vector, or a small-molecule API.

Open COGS analysis Antibody COGS preview

Gowned operators handling a single-use bag in a cleanroom — Hands on a single-use assembly

A 96-well plate used for an assay — The release hold

Incubator shelves holding cell culture flasks — Days the culture occupies

Reusable stirred-tank bioreactors — Vessels from another plant

The pattern

Science often outruns the operating system that has to carry it.

The hard constraints show up late — and usually between functions, not inside one: material lead times, QC/CMO release lag, suite capacity, unclear decision rights. Failed batches, high COGS, and limited capacity hit the P&L. They also mean higher cost of care, delays to the clinic, and shortages for patients.

BiOS is built for that moment: make the interfaces visible, rank what matters for the business, and hand leadership a working tool customized to their situation — across antibodies, cell therapy, viral vector, and small-molecule API. Not an open-ended retainer, and not only a PDF that dies in email.

The offer

Operational Scale-Up Assessment

For COO / Head of Operations leaders at emerging biotechs (~20–150 people), and founders without dedicated senior ops — when clinical manufacturing, scale-up, tech transfer, CDMO change, or release/capacity pressure is on the calendar. Works for antibodies, cell therapy, viral vector, and small-molecule API. One fee. Clear exclusions so scope cannot drift.

First pass

$4,500

Delivery

~10 business days

Your time

~8–12 hours

Check fit for the $4,500 first pass Preview sample pages

Live on this public site today: the tools hub, COGS analysis, Line Balance Lab, and this fit check. A full customer portal to maintain your assessment is not shipped here yet.

Current → future operations map

How process, equipment, materials, quality, data, and ownership must evolve together for the next campaign or lot — in your plant, with your CDMO and release rules.

Ranked cross-functional gaps

The consequential interface failures — with why they matter now — not an exhaustive SOP audit or a generic maturity score.

Now / Next / Later freeze

Sequenced actions and dependencies so you know what to decide this quarter before more spend.

A living tool — not only a PDF

The assessment is the first working version. Ongoing: a simple web interface so you maintain it as campaigns, CDMOs, and release rules change. That customer workspace is not a login portal on this site yet.

What $4,500 looks like

A working decision tool you can act on — not a maturity scorecard.

Illustrative excerpt from the Operational Scale-Up Assessment (fictional company). Sample pages show the first-pass format; the paid work is a tool customized to you — not a one-shot PDF that dies in email.

BiOS

Operational Scale-Up Assessment

NovaCell Therapeutics

Excerpt · Executive Decision Summary

Confidential · Sample

1. Executive Decision Summary

NovaCell is moving a perfusion-based mAb process from development toward early clinical manufacturing readiness. Technical process definition is ahead of the operating system required to run it reliably: material planning, release interfaces, and ownership of cross-functional decisions remain underspecified.

Decision required this quarter

Prioritize a single “scale-up operating path” for the next 90 days—freeze the materials / release / scheduling interfaces before committing additional process characterization spend.

Priority	Finding	Why it matters	Suggested move
P0	Drug substance material demand model not linked to campaign calendar	Lead-time exposure on critical media/filters will slip first tox lot	Build a 2-campaign material risk register with dual-source flags
P0	QC release ownership unclear between NovaCell and CMO partner	Release lag becomes the de facto schedule constraint	Name a single release decision owner + SLA for CoA exceptions
P1	Equipment capacity model assumes ideal changeover	Suite utilization overstated by ~18% in draft plan	Re-baseline changeover + buffer prep window with MSAT + Ops

Full sample continues with Current→Future Operations Map, Gap & Risk Assessment, and Now/Next/Later roadmap (not shown).

Open full sample excerpt Check fit for the $4,500 first passIllustrative sample for a fictional company. Not a real client engagement.

Related formats (not the current offer)

Adjacent assessment shapes we may use later. The paid first pass right now is the Scale-Up Assessment above — a working tool, not a customer login on this site.

Facility Risk Assessment

HelixForge Biologics

View excerpt →

Process Design Assessment

Aurelia BioWorks

View excerpt →

Capability Gap Assessment

Northwind Cell Systems

View excerpt →

How it works

From fit check to a working decision tool.

Fit conversation (20–30 min)

Confirm stage, urgency, and whether the $4,500 Scale-Up Assessment is the right first pass — or not.

Customized systems review

Map the interfaces that constrain your next lot or campaign — process, materials, quality, facilities, data, ownership — as they exist in your situation, not a template.

First-pass working tool (~10 days)

Prioritized gaps, a current→future map, and a Now/Next/Later freeze you can act on this quarter. A working decision tool, not only a PDF.

Keep it living

Intended next step: a simple web-based interface so you maintain the tool as campaigns, CDMOs, and release rules change. That authenticated customer workspace is not live on this site yet.

Not included by default: exhaustive SOP review, detailed engineering design, validation packages, or full implementation projects. Those are separate — and we will say no if they threaten the fixed fee.

What you can use on this public site today: tools and services, including COGS analysis, Line Balance Lab, the scorecard, and the fit check below. The paid first pass is the $4,500 assessment; the customer login to maintain that tool is next, not claimed as live here.

Check fit for the $4,500 first pass

The team

Operators who have lived the interfaces.

BiOS brings ~15 years of combined depth across consulting and biotech operations — process and MSAT, manufacturing, materials and supply chain, equipment and facilities, quality interfaces, automation, and the business decisions that keep those systems coherent. We work across antibodies, cell therapy, viral vector, and small-molecule API.

We help companies make innovative medicines cheaper, faster, and right first time — starting with hosted tools and a fixed-fee Operational Scale-Up Assessment — instead of another open-ended retainer or a one-shot PDF.

Check fit for the $4,500 first pass

Next step

Check fit for the $4,500 first pass.

Tell us your stage and the operational pressure you're under. If it's a fit, we scope a fixed-fee Scale-Up Assessment — a working decision tool customized to your situation — before anything starts (~10 business days, ~8–12 hours of your team's time). A simple web interface for keeping that tool current is the intended follow-on; it is not a customer login on this site yet.

Prefer a live self-check first? Scorecard, Line Balance Lab, or COGS preview.