Milestone Map for Biosimilar Product Development
MPR BIO can support biosimilar product development across most stages of the process, providing comprehensive services from target selection through market commercialization.
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Target Selection & Feasibility
Initial assessment and target identification
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Process Development & Manufacturing
CDMO services from development to scale
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Non-Clinical Studies
Preclinical research and testing
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Clinical Development
Comprehensive clinical trial services
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Regulatory Submission & Authorization
Full regulatory affairs support
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Market Entry & Commercialization
Launch support and market access
Our Comprehensive Capabilities
MPR BIO offers fully integrated end-to-end services across all aspects of biosimilar development.
Clinical Research
Comprehensive clinical development services with end-to-end capabilities covering trial design, patient recruitment, study monitoring, data management, and pharmacovigilance.
Clinical trial design and protocol development
Patient recruitment and site engagement
Safety monitoring and data management
CDMO Capabilities
Fully integrated end-to-end CDMO services specifically designed to accelerate biosimilar development with facilities in Suzhou (high-capacity manufacturing), Boston (advanced CMC and formulation expertise), and regional hubs across MENA, Türkiye, and CEE.
Early-stage cell line development
Process development and optimization
Commercial-scale production
Regulatory Affairs
Comprehensive regulatory support with deep expertise across EMA, FDA, and major emerging markets. Our experienced teams guide clients through the entire submission process.
Regulatory strategy and intelligence
Dossier compilation and submission
Post-approval and market access support
Biostatistics & Safety
Expert biostatistical analysis and drug safety management with standardized data handling and comprehensive pharmacovigilance solutions.
Statistical analysis plan development
Safety event identification and reporting
PK/PD analysis and interim assessments
Our Value Proposition
MPR brings unique advantages to biosimilar clinical research partnerships.
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Deep Biosimilar Expertise
Dedicated therapeutic and clinical teams with hands-on experience across multiple therapeutic areas
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Speed & Startup Efficiency
Industry sensible startup timelines — critical when patent windows are finite
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Established Site Network
Qualified sites with investigators experienced in PK, immunogenicity, and comparator study designs
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Regulatory Intelligence
In-house regulatory affairs expertise integrated into every project team from the outset
Clinical Research Services
Clinical Research Services
✓ Clinical Development Program Management
✓ Flexible Clinical Monitoring Solutions
✓ Resources Optimization
✓ Efficient Study Start-up Initiation
✓ Patient and Site Engagement
Regulatory Affairs
✓ Regulatory Intelligence & Operational Expertise
✓ Strategic and Operational Regulatory Support
✓ Global Regulatory Consulting and Advisory
✓ Product Lifecycle Management
✓ Regulatory Documentation and Submissions
Drug Safety & Data Management
✓ Established Safety Reporting System
✓ Standardization of Clinical Data
✓ Construction of Databases
✓ Pharmacovigilance Solutions
✓ Uniform Data Structuring
Medical Writing
✓ CERs and CEPs (Clinical Evaluation Reports and Plans)
✓ Clinical Research Literature Reviews
✓ User Documentation and Labeling
✓ Summaries of Safety and Clinical Performance (SSCPs)
✓ Implant Cards
Project & Trial Management
✓ Customized Employee Training and Development
✓ Advanced Technologies and Immediate Data Analysis
✓ Perpetual Enhancement of Operational Processes
✓ Adaptive Governance Structures
Biostatistics
✓ Statistical Analysis Plan Development
✓ Analysis and Reporting Including ISS/ISE
✓ Safety Event Identifications and Endpoint Adjudications Support
✓ Interim-Analysis and Safety Updates
✓ PK/PD Analysis
Global CDMO Capabilities
MPR BIO is a global platform that brings biopharmaceutical development into a single system. By combining our proprietary technologies and powdered delivery systems with full manufacturing, regulatory, and commercial infrastructure, we guide products from initial concept to the global market.
Instead of working with multiple fragmented vendors, our clients benefit from innovation, manufacturing, and market access managed under a single operational framework.
Biosimilar Development
Streamlining Biosimilar Projects and Reducing Risk
We specialize in the complex requirements of biosimilars. By providing analytical testing, process optimization, and GMP manufacturing under one roof, we eliminate tech transfer risks and shorten development timelines.
Our core capabilities support every major biosimilar milestone:
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Cell Line Development: Mammalian and microbial cell line creation
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Process Development: Upstream and downstream optimization.
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Purification: Efficient purification scaling and optimization.
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Characterization: Detailed analytical studies to match the reference product.
Scaling & Global Regulatory Support
From Clinical Batches to Commercial Supply
With established formulation, fill-finish, and scalable manufacturing infrastructure, we move products efficiently from clinical trials to full commercial supply.
Additionally, our integrated regulatory team directly manages global filings with major agencies, including the FDA, EMA, and emerging markets.
Workflow of Biopharmaceutical CDMO Services
CMC+CMO
Results from a decade of research on protein therapeutics at research institutes and innovative biopharmaceutical companies.
Clinical study CRO, with strategic partners
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CMO
Phase III, BLA and commercial manufacturing
CRO:
Biopharma discovery and optimization
Cell Line Development
GMP Cell Banking
Media Optimization
Cell Culture Process
Down Stream Process
Scale Up
Clinical Phase
I / II Material
Gene to IND Projects
Clinical Material Manufacturing
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Plasmid, vector, and virus (AAV, LV, Adenovirus, Bac, mRNA, exosomes, etc.) - Cell and Gene therapies
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Serum-free media optimization and customized development
GLP animal studies
Safety and efficacy studies, with strategic partners
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4 different types of MPR BIO CDMO services
Self-own IP of all technologies, media & products for our CDMO services.
CDMO Services
Protein Development and Manufacturing
✓ Mabs
✓ Fc Proteins
✓ Bispecific Abs
✓ Antibodies for ADC
Cell and Gene Therapy
Manufacturing
✓ Vectors / Plasmids
✓ Viruses
✓ Exosomes and cytokines
Custom Cell Culture Media Development
✓ Different kinds of media
Cell Line Optimization
✓ Different kinds of stem cells and primary cells
Cell Suspension Adaptation
✓ Different kinds of cells
Cell Culture Development
✓ Different kinds of stem cells and primary cells
✓ Immune cells, CAR-T, TCR-T, etc.
Serum-free Cell Culture
Media Services and Products
A full range of services and products, including customized cell culture media development, contract manufacturing, and catalog cell culture media products.
Many cell culture media formulations and product development experience with self-owned intellectual property to meet the needs of different customers who are working on protein therapeutics, cell and gene therapies, and vaccines.
Internationally leading serum-free cell culture media development systems and platforms. GMP and non-GMP manufacturing capabilities to support preclinical, clinical and commercial biopharmaceutical needs
Customized Media
Development
Proprietary media formulations
International leading metabolic engineering and metabolic modeling tools
High-throughput platforms
(DOE + Automation)
Contract Media
Manufacturing
Non-GMP powder media manufacturing
(1-50kg / batch)
GMP powder media production
(500kg / batch, annual output > 350 tons)
GMP and non-GMP liquid media production
（500 and 2000L batches, annually over 480,000L)
Catalog Media
Products
CHO, HEK293 and other CD media and feeds
DMEM, F12 and other basic media
Insect cells, Vero cells, BHK21 and other media
T cell and stem cell media
Why Choose MPR BIO
MPR BIO operates a comprehensive global network supporting clinical trials and research across multiple continents.
Access to Large Populations
Access to a combined population of several hundred million provides a substantial pool of participants, including drug-naïve patients.
Qualified Healthcare Professionals
Highly trained and experienced healthcare professionals with strong academic backgrounds, many holding teaching positions at major medical universities.
Cost-Effectiveness
The high geographical reach allows for lower regulatory, operational, and labor costs compared to most Western countries.
High Geographical Reach
Wide-range of capabilities for supporting clinical trials, including bioequivalence and biosimilar clinical trials, with diverse patient populations.
Good Infrastructure
Access to modern hospitals, research centers, and laboratories with the necessary infrastructure and technological capabilities for health research.
Rapid Study Startup and Enrollment
Dedicated team of experts working on administrative and clinical aspects to ensure rapid study startup and overall clinical trial success.
Geographic Footprint & Site Network
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