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LB-204 Process Transfer Plan

LB-204 Process Transfer Plan

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6. Intermediate Hold Times

6.2 Receiving-site hold limits

Intermediates shall be held within the limits established in the sending-site hold-time study. Clarified harvest (HT-3) shall not exceed 96 hours at 2–8 °C.

6.3 Excursion handling

Sofie Voice, in split screen. Talk it through; watch the work get built beside you.

About Sofie Voice

Built across the biopharma ecosystem

  • CDMOs
  • Emerging biotech
  • Commercial biopharma
  • Life sciences technology
  • Engineering & consulting

Why Sofie

Theknowledgebehindeverymedicineisspreadacrosspeople,documents,systemsandstandards.Sofieconnectsittoeveryworkflow,decisionanddeliverable,andkeepseveryconclusiontiedtoitsevidence.

The platform

One platform, from context to decision to deliverable.

Everything your team needs to move complex work forward, with Sofie working alongside them in every surface.

  • Every program, with its context attached

    Files, conversations, deliverables, meetings and collaborators organized around each program, site or client, synced from SharePoint, OneDrive and Google Drive.

    Explore Workspaces

  • Documents that survive the trip to Word

    Sofie drafts, redlines and cites inside a Word-faithful editor your team co-edits in real time, with tracked changes, comments and templates.

    Explore CoDraft

  • Analysis you can see and edit

    Batch data, trending and comparisons in a real spreadsheet: formulas, pivots and charts, with Sofie filling columns and explaining what changed.

    Explore CoSheet

  • From conversation to client-ready

    Decks, dashboards, pages and live trackers that stay connected to the data and chat that produced them. Export to PowerPoint, PDF or video.

    Explore Surfaces

  • Agents that hand work to each other

    Coordinate specialized agents across research, comparison and drafting, with the review points and approvals your experts define.

    Explore Orchestrations

  • Working sessions that write themselves up

    Live transcripts with speakers, notes shaped to the meeting type, and decisions and actions that flow into the work.

    Explore CoMeeting
Larkspur Biologics · Workspaces

Workspaces / Tech Transfer

LB-204 Tech Transfer

Search or ask across 1,284 files…

Syncing from SharePoint · 231 files

Recent files

Name · Modified
HTS-014 Hold-Time Study Report.pdfSending site · 38 pp
LB-204 Transfer Protocol v3.docxM. Kline · 2h ago
BR-2291 Executed Batch Record.pdfReceiving site · 64 pp
SOP-QA-017 Deviation Management.docxEffective 2026-03-01
PPQ Lot Summary.xlsx8 lots · A. Ruiz

The Sofie stack

Five layers. One system of work.

  1. 01Your knowledge

    SOPs, batch records, protocols, specifications and prior work: synced from SharePoint, OneDrive and Google Drive into Workspaces, searchable to the page.

    Explore

  2. 02The regulatory world

    Nine authorities and 36 live sources, from 21 CFR to Form 483s, EudraGMDP and PMDA review reports. Refreshed daily, every claim cited.

    Explore

  3. 03Institutional memory

    Your role, products, preferences and past decisions, kept as governed memory, so work starts where it left off.

    Explore

  4. 04Specialized agents

    Orchestrations coordinate agents across research, comparison and drafting, pausing at the review points your experts define.

    Explore

  5. 05Review-ready work

    CoDrafts, CoSheets and Surfaces your team edits together: the deliverable, with its sources attached.

    Explore
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New · Regulatory Intelligence

The entire regulatory world.
One question away.

Official regulations, guidance, inspections, recalls, shortages and approvals from nine authorities, refreshed every day. Every answer traces to its source, page and date.

Explore Regulatory Intelligence
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regulatory records

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live source connectors
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live source connectors

authorities, from FDA to PMDA
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authorities, from FDA to PMDA

Launch film · Nine regulators, one place, updated every day

FDA drug establishment registrations

10,477 sites. 83 countries.

10,477 FDA-registered drug sites · 83 countries

Ready on day one

116 workflows. 139 templates. Built by operators.

Start from prebuilt biopharma workflows for tech transfer, CQV, quality records, supply chain and regulatory work, or configure your own around the way your organization operates.

Browse the workflow librarySee the templates

Tech Transfer

Tech Transfer Charter Generator

~20–35 hrs per TTC document

Process Development

Process Development Plan Author

~25–45 hrs per PDP document

Analytical Development

Analytical Development Plan Author

~20–35 hrs per ADP document

Tech Transfer

MSAT Execution Plan Author

~25-40 hrs per MEP document

Tech Transfer

MSAT Execution Summary Author

~20–35 hrs per MES document

Tech Transfer

Analytical Transfer Summary Author

~15–25 hrs per ATS document

Tech Transfer

Scale-Down Model Qualification Protocol Author

~20–35 hrs per SDMQ Protocol

CQV

Process Validation Protocol Author

~20–35 hrs per PVP document

CQV

Continued Process Verification Summary Author

~20–35 hrs per CPVS document

Analytical Development

Analytical Validation Summary Author

Substantial hours saved per Analytical Validation Summary versus manual authoring

Tech Transfer

Comparability Report Author

~20–35 hrs per CR document

Quality Records

Quality Risk Assessment (QRM / FMEA, ICH Q9)

15–30 hours across SMEs — convening workshops, building FMEA tables by hand, and normalizing scores.

Quality Records

Site Master File (SMF)

Days to weeks across QA / Regulatory — compiling nine chapters by hand, chasing current site data, retyping tables, and re-checking against the PIC/S format.

Supply Chain

Aseptic Process Simulation (Media Fill)

15–30 hours across MSAT and QA — building worst-case rationale, intervention matrices, and acceptance tables by hand.

Analytical Development

Stability Study

Days of manual table-building, trend analysis, and formatting per report.

Analytical Development

Viral Safety / Adventitious Agent Assessment

Days to weeks across virology and QA — collating cell-bank, testing, and clearance data by hand, reconciling LRVs against criteria, and re-checking against Q5A(R2).

Supply Chain

Supplier Qualification

20–40 hours of supplier-quality time gathering evidence, mapping it to criteria, and formatting the assessment by hand.

Supply Chain

Clinical / IMP Supply Plan

30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand.

Tech Transfer

Tech Transfer Charter Generator

~20–35 hrs per TTC document

Process Development

Process Development Plan Author

~25–45 hrs per PDP document

Analytical Development

Analytical Development Plan Author

~20–35 hrs per ADP document

Tech Transfer

MSAT Execution Plan Author

~25-40 hrs per MEP document

Tech Transfer

MSAT Execution Summary Author

~20–35 hrs per MES document

Tech Transfer

Analytical Transfer Summary Author

~15–25 hrs per ATS document

Tech Transfer

Scale-Down Model Qualification Protocol Author

~20–35 hrs per SDMQ Protocol

CQV

Process Validation Protocol Author

~20–35 hrs per PVP document

CQV

Continued Process Verification Summary Author

~20–35 hrs per CPVS document

Analytical Development

Analytical Validation Summary Author

Substantial hours saved per Analytical Validation Summary versus manual authoring

Tech Transfer

Comparability Report Author

~20–35 hrs per CR document

Quality Records

Quality Risk Assessment (QRM / FMEA, ICH Q9)

15–30 hours across SMEs — convening workshops, building FMEA tables by hand, and normalizing scores.

Quality Records

Site Master File (SMF)

Days to weeks across QA / Regulatory — compiling nine chapters by hand, chasing current site data, retyping tables, and re-checking against the PIC/S format.

Supply Chain

Aseptic Process Simulation (Media Fill)

15–30 hours across MSAT and QA — building worst-case rationale, intervention matrices, and acceptance tables by hand.

Analytical Development

Stability Study

Days of manual table-building, trend analysis, and formatting per report.

Analytical Development

Viral Safety / Adventitious Agent Assessment

Days to weeks across virology and QA — collating cell-bank, testing, and clearance data by hand, reconciling LRVs against criteria, and re-checking against Q5A(R2).

Supply Chain

Supplier Qualification

20–40 hours of supplier-quality time gathering evidence, mapping it to criteria, and formatting the assessment by hand.

Supply Chain

Clinical / IMP Supply Plan

30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand.

Tech Transfer

Process Transfer Plan Author

~25–40 hrs per PTP document

Process Development

Process Development Report Author

~25–45 hrs per PDR document

Analytical Development

Analytical Development Report Author

~25–45 hrs per ADR document

Tech Transfer

Process Characterization Plan Author

~20–35 hrs per PCP document

Tech Transfer

Process Characterization Summary Author

~15–25 hrs per PCS document

Tech Transfer

Technology Transfer Summary Author

~35–50 hrs per TTS document

Tech Transfer

Scale-Down Model Qualification Report Author

~20–35 hrs per SDMQ Report

CQV

Process Validation Summary Author

~20–35 hrs per PVS document

Analytical Development

Analytical Validation Plan Author

~25–40 hrs per AVP document

Tech Transfer

Comparability Plan Author

~20–35 hrs per CP document

Tech Transfer

Knowledge Gap Assessment

~15–25 hrs per knowledge gap assessment

Quality Records

Data Integrity Assessment

Days across QA and IT — pulling configurations and access matrices by hand, mapping data flows, and cross-checking ALCOA+ against Part 11 and Annex 11.

Supply Chain

Master Batch Record (MBR)

30–60 hours across MSAT and production — drafting, formatting, and cross-checking every step and parameter by hand.

Business Development

Capability Pitch Deck

Days hunting through old decks, case studies, and quality records to assemble a story.

Analytical Development

Reference Standard Qualification

Business Operations

Capital Expenditure (CapEx) Justification

40–80 hours across finance, engineering, and manufacturing building the model and narrative by hand.

Business Operations

EHS Risk Assessment / Job Hazard Analysis

8–20 hours across EHS — walking the task, listing hazards by hand, scoring risk in a spreadsheet, and re-checking each control against OSHA and ISO 45001.

Quality Records

Quality Agreement

Tech Transfer

Process Transfer Plan Author

~25–40 hrs per PTP document

Process Development

Process Development Report Author

~25–45 hrs per PDR document

Analytical Development

Analytical Development Report Author

~25–45 hrs per ADR document

Tech Transfer

Process Characterization Plan Author

~20–35 hrs per PCP document

Tech Transfer

Process Characterization Summary Author

~15–25 hrs per PCS document

Tech Transfer

Technology Transfer Summary Author

~35–50 hrs per TTS document

Tech Transfer

Scale-Down Model Qualification Report Author

~20–35 hrs per SDMQ Report

CQV

Process Validation Summary Author

~20–35 hrs per PVS document

Analytical Development

Analytical Validation Plan Author

~25–40 hrs per AVP document

Tech Transfer

Comparability Plan Author

~20–35 hrs per CP document

Tech Transfer

Knowledge Gap Assessment

~15–25 hrs per knowledge gap assessment

Quality Records

Data Integrity Assessment

Days across QA and IT — pulling configurations and access matrices by hand, mapping data flows, and cross-checking ALCOA+ against Part 11 and Annex 11.

Supply Chain

Master Batch Record (MBR)

30–60 hours across MSAT and production — drafting, formatting, and cross-checking every step and parameter by hand.

Business Development

Capability Pitch Deck

Days hunting through old decks, case studies, and quality records to assemble a story.

Analytical Development

Reference Standard Qualification

Business Operations

Capital Expenditure (CapEx) Justification

40–80 hours across finance, engineering, and manufacturing building the model and narrative by hand.

Business Operations

EHS Risk Assessment / Job Hazard Analysis

8–20 hours across EHS — walking the task, listing hazards by hand, scoring risk in a spreadsheet, and re-checking each control against OSHA and ISO 45001.

Quality Records

Quality Agreement

Tech Transfer

Analytical Transfer Plan Author

~18–28 hrs per ATP document

Process Development

Process Development Summary Author

~30–50 hrs per PDS document

Analytical Development

Analytical Development Summary Author

~25–45 hrs per ADS document

Tech Transfer

Technology Transfer Plan Author

~20–35 hrs per TT Plan document

Tech Transfer

Process Transfer Summary Author

~20–30 hrs per PTS document

Tech Transfer

Scale-Down Model Qualification Plan Author

~20–35 hrs per SDMQ Plan

CQV

Process Validation Plan Author

~25–40 hrs per PVP document

CQV

Continued Process Verification Plan Author

~20–35 hrs per CPVP document

Analytical Development

Analytical Validation Protocol Author

~20–30 hrs per AVPr document

Tech Transfer

Comparability Protocol Author

~20–35 hrs per CPR document

Tech Transfer

Lifecycle Management Plan Author

~25–40 hrs per LMP document

Quality Records

Product Quality Review (APR/PQR)

20–40 hours across QA — pulling logs by hand, retyping tables, chasing reconciliation, and re-checking against the regulation.

Supply Chain

In-Process Control & Sampling Plan

15–30 hours building control tables and justifying sample sizes by hand against the standards.

CQV

Cleaning Validation

Analytical Development

Container Closure Integrity (CCI) Study

Supply Chain

Purchase Requisition / Sourcing Package

Hours spreadsheeting apples-to-oranges quotes by hand

Business Operations

Preventive Maintenance & Calibration Program

Days across metrology, QA, and facilities — reconciling registers, tolerances, intervals, and CMMS status by hand, then re-checking against ISO/IEC 17025 and Annex 15.

Supply Chain

Supply Chain Risk & Continuity Plan

Tech Transfer

Analytical Transfer Plan Author

~18–28 hrs per ATP document

Process Development

Process Development Summary Author

~30–50 hrs per PDS document

Analytical Development

Analytical Development Summary Author

~25–45 hrs per ADS document

Tech Transfer

Technology Transfer Plan Author

~20–35 hrs per TT Plan document

Tech Transfer

Process Transfer Summary Author

~20–30 hrs per PTS document

Tech Transfer

Scale-Down Model Qualification Plan Author

~20–35 hrs per SDMQ Plan

CQV

Process Validation Plan Author

~25–40 hrs per PVP document

CQV

Continued Process Verification Plan Author

~20–35 hrs per CPVP document

Analytical Development

Analytical Validation Protocol Author

~20–30 hrs per AVPr document

Tech Transfer

Comparability Protocol Author

~20–35 hrs per CPR document

Tech Transfer

Lifecycle Management Plan Author

~25–40 hrs per LMP document

Quality Records

Product Quality Review (APR/PQR)

20–40 hours across QA — pulling logs by hand, retyping tables, chasing reconciliation, and re-checking against the regulation.

Supply Chain

In-Process Control & Sampling Plan

15–30 hours building control tables and justifying sample sizes by hand against the standards.

CQV

Cleaning Validation

Analytical Development

Container Closure Integrity (CCI) Study

Supply Chain

Purchase Requisition / Sourcing Package

Hours spreadsheeting apples-to-oranges quotes by hand

Business Operations

Preventive Maintenance & Calibration Program

Days across metrology, QA, and facilities — reconciling registers, tolerances, intervals, and CMMS status by hand, then re-checking against ISO/IEC 17025 and Annex 15.

Supply Chain

Supply Chain Risk & Continuity Plan

Sequences & Memory

Work that runs on its own. Context that carries forward.

Sequences handle the recurring and the reactive: a brief every weekday morning, a supplier review when FDA posts a new Form 483, follow-ups when a meeting ends. Memory keeps your team’s standards, preferences and past decisions at hand, and your admins decide what it keeps.

SequencesMemory
Larkspur Biologics · Sequences
Supplier 483 watchActive

When

FDA posts a Form 483 for a approved supplier

40 suppliers · 57 sites

Only if

Observations mention sterility or aseptic processing

Checked on each posting

Then

Run Supplier Risk orchestration

Updates the Supplier risk Surface

Then

Draft notice to Quality

Needs approval before sending

07:00Checked FDA 483 postings · 0 new

Proven outcomes

average time savings per workflow
60–80%
workflows improved across operations in the first 30 days
10–15
of hours returned to teams each month
Hundreds

00:00:00:00

Customer story · Cory Lewis, CEO · In production

INCOG Biopharma × Sofie

2:00 target
“With Sofie, our team members have completed in minutes work that would have taken hours or days. That's not a one-time thing. We've seen it across workflows, across functions. I'm a believer.”
Cory LewisCEO, INCOG Biopharma

Trust & security

Built for work that ends up in front of an inspector.

Every customer runs in an isolated environment, with the controls and oversight regulated operations demand.

More about security

  • An isolated deployment for every customer

    Your own AWS environment: a dedicated VPC, private subnets and an encrypted database. Never shared.

  • Your data never trains a model

    Customer content is used to do your work, and nothing else.

  • Enterprise sign-in

    SAML SSO with Okta, Entra ID, Google and more, passkey MFA and configurable idle timeouts.

  • Human approval where it matters

    Sending, sharing and unattended work pause for approval by default.

  • Evidence for every conclusion

    Answers carry page-level citations; missing evidence is flagged, never invented.

  • Audit trail and access reviews

    Security events, access reviews and record history you can hand to an auditor.

Insights

From the TransferAI team

All insights

Product Announcements

Introducing Regulatory Intelligence in Sofie

Newsletter

The Transfer: August 2026

Product Announcements

Turn Biopharma Work into Polished Deliverables with Surfaces in Sofie

Start with one workflow.
Measure it. Then expand.

In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.

Book a working sessionExplore the platform