Menarini Biotech
Menarini Biotech is a private Italian CDMO providing process development, GMP manufacturing, and analytical services for biopharmaceuticals (mAbs, bispecifics, ADCs, fusion proteins) up to clinical phase III, serving biotech and pharma clients as a subsidiary of The Menarini Group.
- Company typePrivate
- Founded2003
- HeadquartersRome, Italy
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Menarini Biotech does
Menarini Biotech S.r.l. is a private Italian Contract Development and Manufacturing Organization (CDMO) specializing in process development and GMP manufacturing of biopharmaceuticals. Founded in 2003 and headquartered in Pomezia (Rome), Italy, the company operates as a wholly-owned subsidiary of The Menarini Group, a diversified pharmaceutical conglomerate founded in 1886 and present in 140 countries. The company focuses on mammalian cell line development, upstream and downstream process development, analytical method development, GMP manufacturing up to clinical phase III, bioconjugation (including HPAPIs and ADCs), and aseptic fill-finish for monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, fusion proteins, and enzymes. Its facility uses single-use bioreactor platforms from 25L to 1000L scale, with dedicated Class D, C, and B cleanrooms, and is authorized by AIFA for GMP manufacturing of biological active substances up to clinical phase III.
The company's technology stack is built around established bioprocessing platforms: a proprietary purification platform for mAbs and bispecifics, established HPAPI/ADC manufacturing capabilities with 25+ years of experience, single-use upstream processing, and in-house analytical platform methods following ICH Q14 Quality by Design guidelines. Quantifiable performance includes DNA sequence to preclinical studies in 6-9 months, stable pool selection within 5 weeks of transfection, GMP manufacturing scale from 25L to 1000L, and over 50% of QC analyses completed in one working day. The QMS is compliant with cGMP AIFA/EU, ISO 14001, ISO 45001, and ISO 50001, and the company has held IMP manufacturing authorization since 1999.
Menarini Biotech generates revenue through fee-for-service CDMO contracts billed based on project scope, development phase, and manufacturing volume, with multi-year contract cadences. The go-to-market is enterprise-driven, with direct engagement with biopharmaceutical companies, biotech startups, and academic research teams through a business development team, industry conferences (World ADC London, BioEurope Spring/Fall, BIO International, CPhI Europe, Swiss Biotech Day, Festival of Biologics), and direct roadshows at European biotech hubs. In 2025, the company announced a strategic partnership with ERBC, a preclinical CRO, to offer an integrated preclinical-to-CMC pathway targeting First-in-Human clinical trials. The company is also participating in the DINAMO project (2021-2027), an ERDF-funded regional initiative to strengthen development and production capabilities at the Pomezia site.
Menarini Biotech firmographics
Firmographics- Name
- Menarini Biotech
- Legal name
- Menarini Biotech S.r.l.
- Website
- https://www.menarini-biotech.com
- Company type
- Private
- Founded year
- 2003
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Menarini Biotech is a private Italian CDMO providing process development, GMP manufacturing, and analytical services for biopharmaceuticals (mAbs, bispecifics, ADCs, fusion proteins) up to clinical phase III, serving biotech and pharma clients as a subsidiary of The Menarini Group.
- Ownership category
- akta.pro rank
Menarini Biotech industry classification
Industry- Product category
- Biopharmaceutical CDMO Services
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)
- akta.pro secondary industries
- Biologic API/Drug Substance Manufacturing Services (HLAAAKAA), Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)
Keywords
Where Menarini Biotech is headquartered
LocationHeadquarters
- HQ city
- Rome
- HQ country
- Italy
- HQ region
- Europe
Offices1 record
Markets served
Menarini Biotech business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales
Revenue model
- Contract Development and Manufacturing Services: Menarini Biotech generates revenue through providing fee-for-service CDMO capabilities including process development, GMP manufacturing, analytical services, and regulatory support to biopharmaceutical companies. Services are billed based on project scope, development phases, and manufacturing volumes.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom CDMO services priced per project |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
Menarini Biotech product offering
Product offeringCore offering
Menarini Biotech is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end services for biopharmaceuticals, including cell line development, upstream and downstream process development, analytical development, GMP manufacturing using single-use bioreactors (25L to 1,000L), bioconjugation/HPAPI/ADC manufacturing, aseptic filling, and integrated quality and regulatory support. Services cover monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, fusion proteins, and other biologics for clinical phases I through III, licensed up to BSL-2.
Product overview
Menarini Biotech is a fully integrated CDMO (Contract Development and Manufacturing Organization) providing end-to-end biopharmaceutical services. The company operates as a unified platform combining Development Services (Cell Line Development, Process Development, and Analytical Development) with GMP Manufacturing capabilities (Upstream Processing, Downstream Processing, Bioconjugation, and Formulation/Aseptic Filling), all supported by integrated Quality services (Quality Assurance, Quality Control, and Regulatory Affairs). Established in 2003, the company specializes in CHO cell line development and GMP manufacturing of biopharmaceuticals including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and fusion proteins, offering services from early clinical development through Phase III.
Differentiator
Problem solved
Functional benefit
Products and services
- Development Services Comprehensive development services for biopharmaceuticals including cell line development, process development (upstream and downstream), and analytical development, supporting clients from DNA sequence to preclinical studies in 6-9 months.
- GMP Manufacturing GMP manufacturing services for biopharmaceuticals using single-use technologies, covering clinical phases I through III, with BSL-2 authorization, cleanroom facilities (Class D, C, B), and scalable single-use bioreactor systems from 25L to 1,000L.
- Quality Services Comprehensive quality services including quality assurance, quality control, and regulatory affairs to ensure compliance with cGMP requirements and support IMPD/IND submissions for biological active substances.
- Cell Line Development Generation of stable mammalian cell lines with high-throughput single-cell clone selection, vector optimization, and cGMP cell banking to provide IND-enabling material. Stable pool selection within 5 weeks of transfection.
- Process Development (Upstream and Downstream) Upstream development using Quality by Design (QbD) approach with DoE analysis for robust processes scaled up to 1,000L; downstream purification platforms for monoclonal and bispecific antibodies using high-throughput technologies.
- Analytical Development Comprehensive analytical services including platform methods, protein characterization, cell-based potency assays (CDC, ADCC), method validation, comparability studies, and forced degradation studies following ICH guidelines.
- Bioconjugation (HPAPI and ADC Manufacturing) End-to-end services for HPAPI and ADC manufacturing with dedicated Class D, C (ISO 7, 6) and B (ISO 5) cleanroom areas; structural characterization including DAR determination and LC-MS/MS peptide mapping for clinical phases through Phase III.
- Formulation / Aseptic Filling Small volume liquid fill-finish using disposable assemblies with IMP manufacturing authorization since 1999; vial filling, lyophilization, and temperature-controlled storage (2-8°C, -20°C) for clinical studies Phase I-IV.
- Regulatory Affairs Regulatory support including IMPD/IND dossier filing for regulatory submissions; authorized by AIFA for GMP production of biological active substances for clinical phase III.
Quantifiable outcome
- DNA sequence to preclinical studies in 6-9 months
- +3 more outcomes
Companies that use Menarini Biotech
Customer profileSegments3 records
Ideal customer profiles3 records
Menarini Biotech technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Menarini Biotech partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- ERBCcoreStrategic partnership between ERBC (a leading preclinical CRO specializing in safety assessment, pharmacokinetics, bio-analytics, and translational research) and Menarini Biotech for integrated preclinical to CMC development. The partnership offers a continuum from preclinical development to Chemistry, Manufacturing, and Controls (CMC), providing efficient and cost-effective development strategies for biopharmaceuticals, regulatory-ready data through CMC and safety modules, and expert guidance for IND submissions. This partnership targets biopharmaceutical companies, biotech startups, and academic teams seeking an integrated pathway from research to First-in-Human clinical trials.
Scale indicators3 records
Recent moves7 records
Expansion highlights10 records
Menarini Biotech competitors and assessment
Company assessmentBroad incumbents
- Lonza Biologics: Global CDMO leader offering mammalian cell line development, process development, and large-scale GMP manufacturing for mAbs and complex biologics. Directly comparable service portfolio to Menarini Biotech but at significantly larger commercial scale (up to 20,000L).
- Samsung Biologics: Large-scale mammalian CDMO offering cell line development, process development, and GMP manufacturing up to commercial scale. Overlaps with Menarini Biotech in mAb/bispecific process development and clinical-phase manufacturing.
- WuXi Biologics: Global end-to-end biologics CDMO offering discovery, development, and manufacturing services across mammalian and microbial platforms. Comparable to Menarini Biotech across the full biologics CDMO value chain but at much larger scale.
Direct peers
- AGC Biologics: Mammalian and microbial CDMO offering cell line development, process development, and GMP manufacturing for mAbs, recombinant proteins, and bioconjugates. Closely comparable to Menarini Biotech in scale and service mix, with a similar clinical-phase focus.
- Rentschler Biologics: European-based CDMO specializing in mammalian cell culture process development and GMP manufacturing of mAbs, bispecifics, and other complex proteins. Highly comparable in positioning, scale, and customer mix to Menarini Biotech.
- BSP Pharmaceuticals: Italian CDMO located near Latina providing development and GMP manufacturing services for biologics and ADCs. Direct geographic and service-line peer to Menarini Biotech in the Italian/European market.
- Cobra Biologics (Charles River): CDMO providing cell line development, process development, and GMP manufacturing for biologics including mAbs and recombinant proteins. Comparable in clinical-phase focus and customer base to Menarini Biotech.
- Polpharma Biologics: European CDMO offering cell line development, process development, and GMP manufacturing of biosimilars and novel biologics. Comparable service portfolio and European customer base to Menarini Biotech.
- Piramal Pharma Solutions: CDMO with strong bioconjugation and ADC manufacturing capabilities plus broader biologics services. Directly comparable to Menarini Biotech's HPAPI/ADC franchise and a key competitor in this niche.
Regional players
- Olon S.p.A. Italian CDMO focused on microbial fermentation and small-molecule biologics manufacturing. Regional Italian peer with overlapping capabilities in biopharmaceutical development, though more focused on microbial than mammalian systems.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
Menarini Biotech social profiles
Digital presenceMenarini Biotech compliance and trust
Trust signalCompliance5 records
Menarini Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
Menarini Biotech leadership team
Management profileNumber of profiles
Profiles9 records
Menarini Biotech funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Menarini Biotech M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Menarini Biotech
What does Menarini Biotech do?
Menarini Biotech is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end services for biopharmaceuticals, including cell line development, upstream and downstream process development, analytical development, GMP manufacturing using single-use bioreactors (25L to 1,000L), bioconjugation/HPAPI/ADC manufacturing, aseptic filling, and integrated quality and regulatory support. Services cover monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, fusion proteins, and other biologics for clinical phases I through III, licensed up to BSL-2.
Is Menarini Biotech a public or private company?
Menarini Biotech is a private company. It is classified as corporate owned and is currently operating.
When was Menarini Biotech founded?
Menarini Biotech was founded in 2003. It employs 51 to 100 people.
Where is Menarini Biotech based?
Menarini Biotech is headquartered in Rome, Italy, in the Europe region.
How does Menarini Biotech make money?
One revenue line is on record: contract Development and Manufacturing Services.
Who are Menarini Biotech's main competitors?
Broad incumbents on record are Lonza Biologics, Samsung Biologics and WuXi Biologics. Direct peers are AGC Biologics, Rentschler Biologics, BSP Pharmaceuticals, Cobra Biologics (Charles River), Polpharma Biologics and Piramal Pharma Solutions. Olon S.p.A. is listed as a regional player.
Does Menarini Biotech have an API?
No public API is recorded for Menarini Biotech.
What industry is Menarini Biotech in?
Menarini Biotech's product category is Biopharmaceutical CDMO Services. Its primary akta.pro industry code is HLAGABAC, Biologics (mAbs/Recombinant Proteins) CDMO, with a secondary code of HLAAAKAA, Biologic API/Drug Substance Manufacturing Services. Its NAICS code is 325414 and its SIC code is 8731.