Catalent Biologics

What Catalent Biologics does

Catalent Biologics is the biologics-focused division of Catalent, Inc. (NYSE: CTLT), a global contract development and manufacturing organization (CDMO) headquartered in Somerset, New Jersey, operating from 50+ global sites with production capacity of approximately 80 billion doses across nearly 8,000 products annually. The division provides end-to-end development and manufacturing services for protein biologics, cell therapies, and gene therapies, serving pharmaceutical and biotechnology sponsors from early-stage startups through large pharma companies. Its core offerings are organized around four product lines: Biologics (drug substance and drug product, including analytical services), Gene Therapy (AAV and lentiviral vectors plus plasmid DNA), Cell Therapy (autologous and allogeneic, including CAR-T, TCR, TIL, NK, and iPSCs), and Specialty modalities (mRNA, bioconjugates, bispecifics, vaccines, oncolytic viruses). The OneBio Integrated Suite packages these capabilities into a single coordinated workflow from cell line development through commercial supply.

The company's competitive position is built on a portfolio of proprietary technology platforms: GPEx Lightning for cell line development (shortening drug substance timelines by up to three months), UpTempo AAV Platform (reducing gene-to-clinic timelines from 15–18 months to 9 months), UpTempo CAR-T Platform (closed GMP workflow), UpTempo Plasmid DNA Platform (yields up to 0.5g/L), Rapid Antibody Platform (gene-to-GMP drug substance in ~8 months), and SMARTag for antibody-drug conjugate bioconjugation. Manufacturing infrastructure is FDA- and EMA-licensed, including a flagship Harmans/BWI gene therapy campus with 10+ cGMP viral vector suites (with $130M expansion adding five Phase 3/commercial suites), a 60,000 sq ft commercial cell therapy plant in Gosselies, Belgium, and a $44.5M Princeton, NJ cell therapy facility acquired from Erytech.

Catalent Biologics generates revenue through project-based CDMO contracts (development and manufacturing agreements, technology transfer agreements, long-term supply agreements) negotiated directly with sponsors via enterprise field sales. It does not disclose pricing publicly. The division has expanded aggressively via acquisitions between 2020 and 2022 — MaSTherCell Global (Feb 2020, cell therapy), Skeletal Cell Therapy Support SA (Nov 2020, CGxP facility in Belgium), Hepatic Cell Therapy Support SA (May 2021, plasmid DNA), RheinCell Therapeutics (Aug 2021, GMP iPSC), and Erytech's Princeton facility (Apr 2022). Catalent Biologics reports working on 70+ clinical and commercial programs and has supported 1,000+ partner programs historically. Note that standalone Biologics-segment revenue is not disclosed separately by the parent; total Catalent, Inc. revenue was approximately $5B in FY2022.

Name

Catalent Biologics

Legal name

Catalent, Inc.

Website

https://biologics.catalent.com

Company type

Public

Founded year

2012

Operating status

Operating

Short description

Catalent Biologics is the biologics-focused CDMO division of Catalent, Inc. (NYSE: CTLT), providing end-to-end contract development and manufacturing services for protein biologics, cell therapies, and gene therapies to pharmaceutical and biotechnology sponsors globally, leveraging proprietary GPEx, UpTempo, and SMARTag technology platforms across 50+ sites.

Ownership category

akta.pro rank

Product category

Biologics Contract Development and Manufacturing (CDMO)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), Cell Therapy CDMO (HLAGABAD), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

Keywords

• Biologics CDMO services
• Cell therapy manufacturing
• Gene therapy CDMO
• Plasmid DNA services
• Antibody drug conjugates

Headquarters

HQ city

Rockville

HQ country

United States

HQ region

North America

Offices10 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. Biologics CDMO Services: Catalent generates revenue through contract development and manufacturing services for biologics including protein biologics, cell therapies, and gene therapies. Revenue comes from service fees for development, manufacturing, fill/finish, and analytical services across the product lifecycle from early development through commercial supply.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Catalent Biologics is a contract development and manufacturing organization (CDMO) that provides end-to-end biologics, cell therapy, and gene therapy services for pharmaceutical and biotechnology innovators. Its offerings span cell line and viral vector development, drug substance biomanufacturing, fill/finish, and commercial supply, delivered through proprietary technology platforms (GPEx, UpTempo, Rapid Antibody, SMARTag) at FDA- and EMA-licensed facilities in North America and Europe. The company also supports advanced modalities such as mRNA, bioconjugates, bispecifics, vaccines, and iPSC-based therapies.

Product overview

Catalent Biologics is a contract development and manufacturing organization (CDMO) offering a comprehensive portfolio of biologics, cell therapy, and gene therapy services through an integrated platform architecture. The core offerings include Biologics (drug substance and drug product), Gene Therapy (AAV and viral vectors), Cell Therapy (autologous and allogeneic), and Specialty modalities (mRNA, bioconjugates, bispecifics, vaccines). Key technology platforms supporting these services include GPEx® Lightning for cell line development, UpTempo℠ AAV Platform for gene therapy, UpTempo℠ CAR-T Platform for cell therapy, Rapid Antibody Platform for accelerated antibody development, UpTempo℠ Plasmid DNA Platform for plasmid manufacturing, and SMARTag® for bioconjugate development. The OneBio® Integrated Suite provides end-to-end coordination across all services from cell line development through commercial supply.

Differentiator

Problem solved

Functional benefit

Brands

• OneBio Suite: Integrated biologics development and manufacturing suite offering end-to-end solutions from cell line development through commercial supply
• GPEx Lightning
• Rapid Antibody Platform
• UpTempo AAV Platform
• UpTempo CAR-T Platform
• UpTempo Plasmid Platform
• SMARTag

Products and services

• Biologics (Drug Substance & Drug Product) Comprehensive protein biologics development and manufacturing services from cell line through commercial supply, including analytical services, drug substance biomanufacturing, and fill/finish capabilities, targeted at pharmaceutical and biotechnology customers developing monoclonal antibodies, vaccines, biosimilars, and recombinant protein therapeutics.
• Gene Therapy Custom viral vector and plasmid development with scalable CGMP manufacturing for advanced gene therapies, including AAV and lentiviral vectors, targeted at biotech customers developing gene therapies for genetic disorders and rare diseases.
• Cell Therapy Integrated end-to-end cell therapy services with global capacity for autologous and allogeneic therapies, including CAR-T, TCR, TIL, NK cells, and iPSC-based therapies, targeted at cell therapy developers requiring clinical and commercial-scale manufacturing.
• Specialty (mRNA, Bioconjugates, Bispecifics, Vaccines, Oncolytic Viruses, Orphan Drugs) Expertise in advanced therapeutic modalities including mRNA, antibody-drug conjugates, bispecific antibodies, vaccines, and oncolytic viruses, targeted at innovators developing complex biologics requiring specialized analytical and manufacturing capabilities.
• OneBio Integrated Suite End-to-end integrated solution spanning cell line development through commercial supply, combining drug substance, drug product, and analytical services into a coordinated offering for biologics innovators seeking a single CDMO partner across the product lifecycle.
• Plasmid DNA Services GMP plasmid DNA services from milligram to gram scale for viral and non-viral applications, including off-the-shelf AAV and lentiviral plasmids, E. coli cell line development, and R&D through CGMP quality grades, targeted at gene therapy and cell therapy developers needing viral vector starting materials.
• Cell Therapy Fill & Finish Fill and finish services for autologous cell therapies (bag filling under aseptic conditions, visual inspection, controlled freezing, vapor phase nitrogen storage) and allogeneic cell therapies (closed-vial system, Crystal M1 station filling), targeted at cell therapy developers preparing products for clinical and commercial distribution.
• GPEx Lightning Cell Line Development Proprietary cell line development technology leveraging a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system with novel gene insertion to shorten drug substance development by up to three months compared to previous timelines, offered as a standalone platform service to biologics innovators.
• UpTempo AAV Platform Scalable AAV platform process with in-house clonal HEK293 cell line and off-the-shelf plasmids, accelerating time from gene to clinic for AAV gene therapies and reducing the typical timeline from 15–18 months to approximately 9 months.
• UpTempo CAR-T Platform Fully closed, GMP-compliant CAR-T cell therapy workflow with data-driven process guidance, automated aseptic connections, and minimal hands-on operator time, suitable for both autologous and allogeneic CAR-T cell therapy manufacturing.
• Rapid Antibody Platform Integrated antibody development platform combining advanced technologies, parallel development strategies, and scalable solutions to deliver gene-to-GMP drug substance in as little as 8 months for antibody programs.
• UpTempo Plasmid DNA Platform High-yielding plasmid DNA manufacturing process capable of producing up to 0.5g of purified plasmid DNA per liter of fermentation culture, using a fully disposable manufacturing process to reduce turnaround time and mitigate cross-contamination risk for viral vector and gene therapy customers.
• SMARTag Bioconjugate Technology Proprietary antibody-drug conjugate technology platform enabling precision-based bioconjugation with specialized linkers for antibody-drug conjugate candidates, targeted at biotech and pharma developers of cytotoxic and targeted bioconjugate therapeutics.
• Manufacturing by Design (MbD) Methodology Custom cell therapy methodology leveraging Quality by Design (QbD) principles to address scalability and supply chain complexity in autologous and allogeneic cell therapy process development.

Quantifiable outcome

• Reduces drug substance development timeline by up to 3 months compared to previous timelines with GPEx Lightning platform
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core.

• Siren BiotechnologycoreStrategic or Co-development Partner · 12 June 2025Siren Biotechnology has a strategic partnership with Catalent for process development and cGMP manufacturing of its universal AAV immuno-gene therapy for solid tumor cancers. The partnership supports SRN-101 which has received FDA Orphan Drug and Rare Pediatric Disease designations. Catalent provides process development and manufacturing services for Siren's gene therapy candidate.
• AavantiBiocoreStrategic or Co-development Partner · 27 April 2021AavantiBio partnered with Catalent for development and manufacturing of gene therapies including its lead AAV vector-based therapeutic candidate for Friedreich's Ataxia. Catalent provides process development and CGMP manufacturing for clinical trials in the U.S. and Europe, with process optimization at its Baltimore, Maryland center.
• Passage BiocoreStrategic or Co-development Partner · 7 December 2020Passage Bio partnered with Catalent for CGMP manufacturing of AAV gene therapy products for rare monogenic CNS disorders. Catalent completed a dedicated CGMP manufacturing suite at its Harmans, Maryland facility for Passage Bio. The partnership includes manufacturing using Pall Corporation's iCELLis single-use fixed-bed bioreactor technology and packaging/labeling services through FastChain demand led supply.
• T-knifecoreStrategic or Co-development Partner · 21 September 2020T-knife signed technology transfer and manufacturing agreement with Catalent for autologous TCR-based cell therapy (T1367) targeting MAGE-A1 positive tumors. Catalent undertakes transfer of T-knife's platform process at Gosselies, Belgium for European trials and Houston, Texas for North American trials.
• BrainStorm Cell TherapeuticscoreStrategic or Co-development PartnerBrainStorm Cell Therapeutics partnered with Catalent for the manufacture of NurOwn mesenchymal stem cell platform therapy.

Scale indicators10 records

Recent moves8 records

Expansion highlights8 records

Market position

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/CatalentPharma
• YouTubeyoutube.com/c/CatalentPharma
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/catalent

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries6 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Catalent Biologics