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MyCellHub

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uuid000311l

Namestring
MyCellHub
Legal namestring
MyCellHub
Websiteurl
mycellhub.com
Company typeenum
Private
Founded yearint
2019
Descriptiontext

MyCellHub is a Belgium-based (Leuven) software provider that develops a cloud-based Manufacturing Execution System (MES) for regulated life sciences and advanced therapy manufacturers. Founded in 2019, the company targets manufacturers of cell therapies, gene therapies, and other advanced biotherapy products who require GMP-compliant production environments and electronic records compliance under 21 CFR Part 11. Its platform replaces paper-based batch records and quality management workflows with digital equivalents, addressing the traceability, data integrity, and real-time visibility requirements specific to advanced therapy manufacturing — a vertical where most manufacturers still rely on manual documentation despite stringent regulatory expectations.

The product, branded the MyCellHub Bio-Manufacturing Execution System, delivers three principal capabilities: real-time production monitoring, digital batch record management, and embedded quality management. The platform is architected as a cloud-native MES with secure digital workflows purpose-built for regulated environments; its differentiators are domain specialization (workflows designed for cell and gene therapy rather than generalized to all pharma), performance speed (real-time production visibility rather than batch reporting), and integration (quality management embedded directly into the execution layer rather than delivered as a separate bolt-on). The technical stack is not disclosed beyond these functional descriptions.

MyCellHub operates as a B2B enterprise software vendor using a subscription/recurring revenue model based on cloud MES licensing. Go-to-market relies on direct enterprise sales to regulated life sciences manufacturers, with vertical segmentation focused on advanced therapy production and primary pain points centered on paper-based GMP processes, traceability gaps, and 21 CFR Part 11 compliance. The company has been a privately held, VC-backed entity (with reported funding from Gemma Frisius Fund, Meusinvest/Noshaq, LRM, The Faktory Fund, The CoFoundry, and KU Leuven) until its acquisition by Title21 Health Solutions — an ARCHIMED portfolio company — in January 2026, which extends distribution into North America and Australia alongside its Belgian/European base.

Short descriptiontext

MyCellHub is a Belgium-based provider of cloud-based Manufacturing Execution System software for regulated life sciences and advanced therapy manufacturers, enabling real-time production monitoring, digital batch records, and embedded quality management for GMP-compliant cell and gene therapy production.

Operating statusenum
Acquired
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersLeuven, Belgium
HQ citystring
Leuven
HQ countrystring
Belgium
HQ regionstring
Europe
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
manufacturing execution system, cell therapy software, GMP compliance platform, bioprocess monitoring software, life sciences MES
Industry2 codes
1Manufacturing Informatics for Biopharma (MES/EBR/Batch Records for GMP)
CodeHLAGAJAJPrimaryYes
2Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES)
CodeHLAAAJAEPrimaryNo
NAICS code1 code
  • Computer Systems Design and Related Services54151
SIC code1 code
  • Services-Computer Programming, Data Processing, Etc.7370
Product category
Life Sciences Manufacturing Execution Systems
Social media profiles2 records
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1MES Software Licensing/Subscription
TypeSubscription Recurring
Description

MyCellHub generated revenue through cloud-based MES software licensing and subscription fees for its manufacturing execution system platform designed for regulated life sciences manufacturing. The company was acquired by Title21 Health Solutions in January 2026.

pulse2.com
Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeSoftware
Software
Core offering1 text field

MyCellHub provides a cloud-based Manufacturing Execution System (MES) purpose-built for regulated life sciences and advanced therapy manufacturers (including cell and gene therapy producers). The platform delivers real-time production monitoring, digital batch record management, and embedded quality management, replacing paper-based GMP workflows with secure digital records compliant with 21 CFR Part 11.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

MyCellHub offers a single unified cloud-based manufacturing execution system for GMP operations in regulated life sciences and advanced therapy manufacturing. The platform provides real-time production monitoring, digital batch record management, and embedded quality management capabilities designed to replace paper-based GMP processes with secure digital workflows compliant with electronic records regulations like 21 CFR Part 11.

Product and service1 record
1MyCellHub Bio-Manufacturing Execution System
Scale indicator1 record

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-01-08
Description

Title21 Health Solutions, a provider of enterprise quality management systems and cell and gene therapy orchestration platforms and an ARCHIMED portfolio company, acquired MyCellHub in January 2026. The acquisition expands Title21's digital solution portfolio to include MyCellHub's real-time production monitoring, digital batch record management, and embedded quality management capabilities while extending geographic coverage from North America and Australia into Europe.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Acquirer of MyCellHub and provider of enterprise QMS and cell/gene therapy orchestration platforms. Directly comparable as both serve advanced therapy manufacturers with GMP-focused digital software stacks and now share the same product portfolio.

TypeDirect peer
Description

Market-leading MES platform purpose-built for pharmaceutical and biopharmaceutical manufacturing, including biologics and cell therapy workflows. Directly competes with MyCellHub for regulated biopharma MES deals and offers similar batch record and GMP compliance capabilities.

TypeDirect peer
Description

Cloud-native manufacturing execution and intelligence platform for life sciences, including cell and gene therapy manufacturers. Directly comparable to MyCellHub as a modern, cloud-based MES targeting similar regulated life sciences customers.

TypeBroad incumbent
Description

Established provider of quality management and manufacturing execution software for life sciences. Broader portfolio spans QMS, MES, and document management across pharma, medical devices, and biotech, overlapping with MyCellHub's QMS-embedded MES capabilities.

TypeBroad incumbent
Description

Large life sciences cloud software platform with Vault Manufacturing suite covering batch records, quality, and production execution. Competes for the same regulated life sciences manufacturers as MyCellHub but operates at significantly greater scale.

TypeBroad incumbent
Description

Rockwell's dedicated pharma/biotech MES offering, providing batch execution, electronic batch records, and integration with control systems. Competes with MyCellHub in regulated biopharma manufacturing but as part of a much broader industrial automation portfolio.

TypeBroad incumbent
Description

Siemens's MES solution covering regulated industries including pharmaceuticals and biotech. Overlaps with MyCellHub on production monitoring and batch execution but serves a much wider industrial manufacturing customer base.

TypeEmerging player
Description

Provider of LIMS, ELN, and manufacturing execution software for life sciences labs and production environments. Comparable to MyCellHub in serving regulated life sciences digital workflows, with partial overlap in biopharma manufacturing informatics.

TypeBroad incumbent
Description

Honeywell-owned QMS and manufacturing operations platform widely used in pharma and biotech. Adjacent to MyCellHub on the quality management side, increasingly overlapping on batch record and digital GMP workflows for life sciences customers.

TypeEmerging player
Description

No-code manufacturing app platform with growing footprint in life sciences, including pharma and biotech production use cases. Emerging peer to MyCellHub in the cloud MES space, with broader applicability but less depth in cell/gene therapy workflows.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles3 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance1 record

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds2 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors6 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

MyCellHub

Life Sciences Manufacturing Execution Systemsmycellhub.com

MyCellHub is a Belgium-based provider of cloud-based Manufacturing Execution System software for regulated life sciences and advanced therapy manufacturers, enabling real-time production monitoring, digital batch records, and embedded quality management for GMP-compliant cell and gene therapy production.

What MyCellHub does

MyCellHub is a Belgium-based (Leuven) software provider that develops a cloud-based Manufacturing Execution System (MES) for regulated life sciences and advanced therapy manufacturers. Founded in 2019, the company targets manufacturers of cell therapies, gene therapies, and other advanced biotherapy products who require GMP-compliant production environments and electronic records compliance under 21 CFR Part 11. Its platform replaces paper-based batch records and quality management workflows with digital equivalents, addressing the traceability, data integrity, and real-time visibility requirements specific to advanced therapy manufacturing — a vertical where most manufacturers still rely on manual documentation despite stringent regulatory expectations.

The product, branded the MyCellHub Bio-Manufacturing Execution System, delivers three principal capabilities: real-time production monitoring, digital batch record management, and embedded quality management. The platform is architected as a cloud-native MES with secure digital workflows purpose-built for regulated environments; its differentiators are domain specialization (workflows designed for cell and gene therapy rather than generalized to all pharma), performance speed (real-time production visibility rather than batch reporting), and integration (quality management embedded directly into the execution layer rather than delivered as a separate bolt-on). The technical stack is not disclosed beyond these functional descriptions.

MyCellHub operates as a B2B enterprise software vendor using a subscription/recurring revenue model based on cloud MES licensing. Go-to-market relies on direct enterprise sales to regulated life sciences manufacturers, with vertical segmentation focused on advanced therapy production and primary pain points centered on paper-based GMP processes, traceability gaps, and 21 CFR Part 11 compliance. The company has been a privately held, VC-backed entity (with reported funding from Gemma Frisius Fund, Meusinvest/Noshaq, LRM, The Faktory Fund, The CoFoundry, and KU Leuven) until its acquisition by Title21 Health Solutions — an ARCHIMED portfolio company — in January 2026, which extends distribution into North America and Australia alongside its Belgian/European base.

MyCellHub firmographics

Firmographics
Name
MyCellHub
Legal name
MyCellHub
Website
https://mycellhub.com
Company type
Private
Founded year
2019
Operating status
Acquired
Headcount range
11–50 employees
Short description
MyCellHub is a Belgium-based provider of cloud-based Manufacturing Execution System software for regulated life sciences and advanced therapy manufacturers, enabling real-time production monitoring, digital batch records, and embedded quality management for GMP-compliant cell and gene therapy production.
Ownership category
akta.pro rank

MyCellHub industry classification

Industry
Product category
Life Sciences Manufacturing Execution Systems
NAICS
Computer Systems Design and Related Services (54151)
SIC
Services-Computer Programming, Data Processing, Etc. (7370)
akta.pro primary industry
Manufacturing Informatics for Biopharma (MES/EBR/Batch Records for GMP) (HLAGAJAJ)
akta.pro secondary industry
Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES) (HLAAAJAE)

Keywords

  • Manufacturing execution system
  • Cell therapy software
  • GMP compliance platform
  • Bioprocess monitoring software
  • Life sciences MES

Where MyCellHub is headquartered

Location

Headquarters

HQ city
Leuven
HQ country
Belgium
HQ region
Europe

Offices1 record

Markets served

MyCellHub business model

Business model
GTM type
B2B
Offering type
Software
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

  1. MES Software Licensing/Subscription: MyCellHub generated revenue through cloud-based MES software licensing and subscription fees for its manufacturing execution system platform designed for regulated life sciences manufacturing. The company was acquired by Title21 Health Solutions in January 2026.

Go-to-market motion1 record

Distribution channels1 record

MyCellHub product offering

Product offering

Core offering

MyCellHub provides a cloud-based Manufacturing Execution System (MES) purpose-built for regulated life sciences and advanced therapy manufacturers (including cell and gene therapy producers). The platform delivers real-time production monitoring, digital batch record management, and embedded quality management, replacing paper-based GMP workflows with secure digital records compliant with 21 CFR Part 11.

Product overview

MyCellHub offers a single unified cloud-based manufacturing execution system for GMP operations in regulated life sciences and advanced therapy manufacturing. The platform provides real-time production monitoring, digital batch record management, and embedded quality management capabilities designed to replace paper-based GMP processes with secure digital workflows compliant with electronic records regulations like 21 CFR Part 11.

Differentiator

Problem solved

Functional benefit

Products and services

  • MyCellHub Bio-Manufacturing Execution System

Companies that use MyCellHub

Customer profile

Segments2 records

Ideal customer profiles1 record

MyCellHub technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature4 records

MyCellHub partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • Title21 Health SolutionscoreStrategic or Co-development Partner · 8 January 2026Title21 Health Solutions, a provider of enterprise quality management systems and cell and gene therapy orchestration platforms and an ARCHIMED portfolio company, acquired MyCellHub in January 2026. The acquisition expands Title21's digital solution portfolio to include MyCellHub's real-time production monitoring, digital batch record management, and embedded quality management capabilities while extending geographic coverage from North America and Australia into Europe.

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

MyCellHub competitors and assessment

Company assessment

Direct peers

  • Title21 Health Solutions: Acquirer of MyCellHub and provider of enterprise QMS and cell/gene therapy orchestration platforms. Directly comparable as both serve advanced therapy manufacturers with GMP-focused digital software stacks and now share the same product portfolio.
  • Werum PAS-X (Körber): Market-leading MES platform purpose-built for pharmaceutical and biopharmaceutical manufacturing, including biologics and cell therapy workflows. Directly competes with MyCellHub for regulated biopharma MES deals and offers similar batch record and GMP compliance capabilities.
  • Apprentice.io: Cloud-native manufacturing execution and intelligence platform for life sciences, including cell and gene therapy manufacturers. Directly comparable to MyCellHub as a modern, cloud-based MES targeting similar regulated life sciences customers.

Broad incumbents

  • MasterControl: Established provider of quality management and manufacturing execution software for life sciences. Broader portfolio spans QMS, MES, and document management across pharma, medical devices, and biotech, overlapping with MyCellHub's QMS-embedded MES capabilities.
  • Veeva Systems: Large life sciences cloud software platform with Vault Manufacturing suite covering batch records, quality, and production execution. Competes for the same regulated life sciences manufacturers as MyCellHub but operates at significantly greater scale.
  • Rockwell Automation PharmaSuite: Rockwell's dedicated pharma/biotech MES offering, providing batch execution, electronic batch records, and integration with control systems. Competes with MyCellHub in regulated biopharma manufacturing but as part of a much broader industrial automation portfolio.
  • Siemens Opcenter Execution (formerly SIMATIC IT): Siemens's MES solution covering regulated industries including pharmaceuticals and biotech. Overlaps with MyCellHub on production monitoring and batch execution but serves a much wider industrial manufacturing customer base.
  • Sparta Systems (Honeywell) TrackWise: Honeywell-owned QMS and manufacturing operations platform widely used in pharma and biotech. Adjacent to MyCellHub on the quality management side, increasingly overlapping on batch record and digital GMP workflows for life sciences customers.

Emerging players

  • LabVantage Solutions: Provider of LIMS, ELN, and manufacturing execution software for life sciences labs and production environments. Comparable to MyCellHub in serving regulated life sciences digital workflows, with partial overlap in biopharma manufacturing informatics.
  • Tulip Interfaces: No-code manufacturing app platform with growing footprint in life sciences, including pharma and biotech production use cases. Emerging peer to MyCellHub in the cloud MES space, with broader applicability but less depth in cell/gene therapy workflows.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

MyCellHub social profiles

Digital presence

MyCellHub compliance and trust

Trust signal

Compliance1 record

MyCellHub financial estimates

Financial estimate

Revenue estimate

Valuation estimate

MyCellHub leadership team

Management profile

Number of profiles

Profiles3 records

MyCellHub funding detail

Funding detail

Funding overview

Funding rounds2 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

MyCellHub M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about MyCellHub

What does MyCellHub do?

MyCellHub provides a cloud-based Manufacturing Execution System (MES) purpose-built for regulated life sciences and advanced therapy manufacturers (including cell and gene therapy producers). The platform delivers real-time production monitoring, digital batch record management, and embedded quality management, replacing paper-based GMP workflows with secure digital records compliant with 21 CFR Part 11.

Is MyCellHub a public or private company?

MyCellHub is a private company. It is classified as corporate owned and is currently acquired.

When was MyCellHub founded?

MyCellHub was founded in 2019. It employs 11 to 50 people.

Where is MyCellHub based?

MyCellHub is headquartered in Leuven, Belgium, in the Europe region.

How does MyCellHub make money?

One revenue line is on record: MES Software Licensing/Subscription.

Who are MyCellHub's main competitors?

Direct peers on record are Title21 Health Solutions, Werum PAS-X (Körber) and Apprentice.io. Broad incumbents are MasterControl, Veeva Systems, Rockwell Automation PharmaSuite, Siemens Opcenter Execution (formerly SIMATIC IT) and Sparta Systems (Honeywell) TrackWise. Emerging players are LabVantage Solutions and Tulip Interfaces.

Does MyCellHub have an API?

No public API is recorded for MyCellHub.

What industry is MyCellHub in?

MyCellHub's product category is Life Sciences Manufacturing Execution Systems. Its primary akta.pro industry code is HLAGAJAJ, Manufacturing Informatics for Biopharma (MES/EBR/Batch Records for GMP), with a secondary code of HLAAAJAE, Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES). Its NAICS code is 54151 and its SIC code is 7370.

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Live signals
Panama City News-HeraldTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions announced the acquisition of MyCellHub, a provider of manufacturing execution systems for life sciences and advanced therapies, expanding its digital solutions portfolio. The acquisition aims to enhance data sharing, transparency, and operational efficiency across the advanced therapies ecosystem, including European markets.Record SearchlightTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions, a provider of enterprise quality management systems and cell and gene therapy orchestration platforms, has acquired MyCellHub, a Belgium-based company offering a cloud-based manufacturing execution system for regulated life sciences and advanced therapy manufacturing.The Herald-TimesTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions has acquired MyCellHub, a Belgium-based provider of cloud-based manufacturing execution system technology designed for regulated life sciences and advanced therapy manufacturing. The acquisition adds real-time production monitoring, digital batch record management, and embedded quality management capabilities to Title21's portfolio while extending the company's geographic coverage from North America and Australia into Europe. The deal positions Title21 as a single-source provider for cell and gene therapy operations spanning standard of care, advanced biotherapy manufacturing, integrated analytics, and quality management systems.Asbury Park PressTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions, a provider of enterprise quality management systems and cell and gene therapy orchestration platforms, has acquired MyCellHub, a Belgium-based company offering a cloud-based manufacturing execution system (MES) for regulated life sciences and advanced therapy manufacturing. The acquisition expands Title21's digital solution portfolio to include real-time production monitoring, digital batch record management, and embedded quality management, while extending the company's geographic coverage from North America and Australia into Europe. Title21, an ARCHIMED portfolio company, positions itself as a single-source provider for standard of care, advanced biotherapy manufacturing, integrated analytics, and quality management systems following the deal.The Desert SunTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions announced the acquisition of MyCellHub, a Belgium-based company specializing in cloud-based manufacturing execution systems for regulated life science and advanced therapy manufacturing. The strategic acquisition enables Title21 to expand its digital solution portfolio with real-time production monitoring, digital batch record management, and embedded quality management capabilities specifically designed for healthcare, biotech, and cell therapy sectors. The deal extends Title21's geographic coverage from North America and Australia to include Europe.The Northwest Florida Daily NewsTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions announced the acquisition of MyCellHub, a Belgium-based company specializing in cloud-based manufacturing execution systems for the life sciences and advanced therapy sectors. The acquisition, completed on January 6, 2026, enables Title21 to expand its digital solution portfolio with real-time production monitoring and 21 CFR Part 11-compliant digital batch record management capabilities. The deal extends Title21's geographic coverage from North America and Australia to include Europe.Columbia Daily TribuneTitle21 Health Solutions Acquires MyCellHub to Expand Digital Capabilities in Life Sciences and Advanced TherapiesTitle21 Health Solutions, a provider of enterprise quality management systems and cell and gene therapy orchestration platforms, has acquired MyCellHub, a Belgium-based company offering cloud-based manufacturing execution system technology for regulated life sciences and advanced therapy manufacturing. The acquisition expands Title21's geographic coverage from North America and Australia into Europe while positioning the company as a single-source provider for standard of care, advanced biotherapy manufacturing, integrated analytics, and quality management systems. The CEOs of both companies highlighted alignment in their vision for digitalizing GMP operations and advancing patient safety in the life sciences industry.Pulse 2.0Title21 Health Solutions Acquires MyCellHub To Add MES Platform For Cell And Gene Therapy ManufacturingTitle21 Health Solutions has acquired MyCellHub, a Belgium-based company offering a cloud-based manufacturing execution system for cell and gene therapy workflows, with financial terms undisclosed. The acquisition expands Title21's advanced therapy capabilities by adding real-time production monitoring and digital batch record technology while extending its geographic coverage from North America and Australia into Europe, where manufacturers face stringent regulatory requirements and growing demand for traceability. MyCellHub's platform is designed to replace paper-based GMP processes with secure digital workflows compliant with electronic records regulations like 21 CFR Part 11.ContractpharmaTitle21 Health Solutions Acquires MyCellHub and Its MES PlatformTitle21 Health Solutions has acquired MyCellHub and its advanced manufacturing execution system (MES) platform, strengthening its position as a data bridge across the advanced therapies ecosystem. The acquisition enables Title21 to become a single-source provider for cell therapy manufacturing, integrated analytics, and quality management systems, while expanding its geographic coverage from North America and Australia into Europe. The Belgium-based MyCellHub team will join Title21, bringing real-time production monitoring and digital batch record management capabilities tailored for the healthcare, biotech, and cell therapy sectors.