01

Intake

Upload program materials

Spekl starts with the documents and entries that already define the program: protocols, CMC summaries, assay plans, and technical notes.

Spekl structured

Research paper.pdf

User-provided source

Published precedent

Read

Clinical protocol.pdf

User-provided source

Study context

Read

Experimental protocol.docx

User-provided source

Process detail

Read

Supplemental methods.docx

User-provided source

Assay support

Read

Draft IND.docx

User-provided source

Regulatory context

Read

CMC summary.docx

User-provided source

Manufacturing scope

Read

Assay plan.xlsx

User-provided source

Analytics

Read

Batch notes.txt

User-provided source

Process assumptions

Queued

Spekl does not begin with a vendor list.

The first step is organizing the program context clearly enough for CMC and manufacturing fit to be evaluated.

02

Define

Define the product through CQAs

User-provided materials become structured records that separate what is known, what is inferred, and what still needs review.

Spekl structured

Spekl defines the product in manufacturing terms before matching begins. Critical quality attributes become part of the evidence-backed logic used to evaluate process, quality, scale, and partner fit.

Review item 01

DS scope

Flagged before matching begins.

Review item 02

Release assay detail

Flagged before matching begins.

Review item 03

Suite model

Flagged before matching begins.

Quality attribute

Dose

Acceptance criteria

Target dose range defined for clinical administration

Evidence

Draft IND.docx

Quality attribute

Identity

Acceptance criteria

CD3+ T cell population confirmed before release

Evidence

Assay plan.xlsx

Quality attribute

Viability

Acceptance criteria

Minimum release threshold defined for clinical supply

Evidence

Clinical protocol.pdf

Quality attribute

Viable cell number

Acceptance criteria

Viable cell count aligned to dose and fill strategy

Evidence

Experimental protocol.docx

Quality attribute

Vector copy / transduction

Acceptance criteria

Transduction efficiency and release assay path identified

Evidence

CMC summary.docx

Quality attribute

Mycoplasma

Acceptance criteria

Negative result required before release

Evidence

Supplemental methods.docx

Quality attribute

Endotoxin

Acceptance criteria

Release threshold defined for final drug product

Evidence

Draft IND.docx

Quality attribute

Potency

Acceptance criteria

Functional assay linked to proposed mechanism of action

Evidence

Research paper.pdf

Quality attribute

Sterility

Acceptance criteria

Release testing window aligned to batch cadence

Evidence

User entry

03

Map

Build the process map

Unit operations, equipment, analytics, and timing are organized into a process-flow view that a technical team can inspect.

Spekl structured

Manufacturing logic becomes visible and reviewable across equipment, unit operations, analytics, and timing.

PFD Complete
Equipment
Unit Operations
Analytics
Day 1
BSCCell counter

STEP 1

Leukapheresis receipt

Receipt, accessioning, and initial material checks.

Viability

In-process
↓
CliniMACSIncubator

STEP 2

T cell activation

Closed-system activation with CD3/CD28 beads.

Identity

In-process
↓
Day 1-3
BSCLovo

STEP 3

Viral transduction

Lentiviral transduction under clinical process controls.

Transduction efficiency

Release
↓
Day 3-7
G-RexIncubator

STEP 4

Expansion

Controlled culture expansion to target viable cell number.

Cell count

In-process
↓
Day 7
LovoBSC

STEP 5

Harvest

Wash, concentrate, and prepare material for final formulation.

Viability

In-process
↓
Day 8
Fill manifoldCryobags

STEP 6

Fill & finish

Final fill, labeling, cryopreservation, and release hold.

Sterility

Release
04

Criteria

Convert science into fit criteria

Spekl translates product needs into manufacturing specifications before any CDMO shortlist is considered.

Spekl structured

Process knowledge

  • Closed autologous handling
  • T cell activation
  • Viral transduction
  • Expansion
  • Vial filling

Equipment required

  • BSC access
  • Closed activation platform
  • Incubator capacity
  • Wash and concentration system
  • Fill manifold

Compliance environment

  • FDA inspection-ready quality system
  • BSL-2 controls
  • ISO 7 / Grade B processing fit
  • Clinical release documentation

Scale constraint

  • 10 batches per month
  • 12-month campaign
  • Clinical-grade material
  • Drug substance and drug product
  • Global distribution
05

Match

Match on manufacturing logic

Partner fit is based on process, quality, scale, timing, and readiness, not keyword search or directory categories.

Spekl structured
Strong fit
Autologous workflowViral transductionISO 7 / BSL-2Q1 start plausible
Closed activationRelease QC fitDS + DP scope
Clinical phase fitCold-chain modelSuite availability
Conditional fit
Capacity after Q2Assay transfer unresolvedQA path review
DP scope availableVector handling confirmTimeline risk
Equipment fit partialOpen tech diligenceSlot dependent
Excluded
No viral vector handlingBSL-2 mismatchExcluded
DP-only scopeNo autologous handlingExcluded
Scale mismatchRelease testing gapExcluded
06

Engage

Prepare partner engagement

Biotechs and manufacturers start with clearer scope, fewer false starts, and better technical context.

Spekl structured

Partner brief preview

Cell Therapy Phase I Supply

Program snapshot

Phase I autologous cell therapy; DS + DP scope; Q1 2027 target start

Manufacturing scope

Closed activation, viral transduction, expansion, harvest, fill & finish

Fit rationale

Process, equipment, compliance environment, scale, and quality requirements align

Readiness status

CQA table structured; process map complete; assay transfer details under review

The partner packet keeps the matching logic visible after shortlist creation.

Focused intake questions

1

Can the site support closed autologous activation and viral transduction?

2

Can ISO 7 / BSL-2 operations support 10 batches per month over 12 months?

3

Can release assay transfer support the proposed Q1 start?

4

Which readiness items must be resolved before quote or slot reservation?

Spekl helps early teams enter CDMO conversations with the questions that actually test fit.

Built for both sides of the decision

Executives see the manufacturing path. Technical teams can inspect the logic.

Scope and partner-readiness are visible before outreach.
Process, quality, scale, and timing constraints are explicit.
Matching rationale is inspectable by the point person running the search.
Manufacturers receive better-prepared opportunities.

Request access

Bring manufacturing clarity to promising science.

Spekl is opening access with selected biotech and manufacturing teams. We will contact you before requesting sensitive program materials.

For biotechsFor manufacturers