BIOSIMILARS
End-to-End Expertise for Biosimilar Development
Provis offers comprehensive biosimilar development services spanning the complete product lifecycle from early discovery through commercial manufacturing. Our capabilities in Microbial (E. coli) and Mammalian (CHO) expression systems enable us to support diverse therapeutic proteins across multiple complexity levels and therapeutic areas.
Proven Biosimilar Development Expertise
Our team brings demonstrated experience in successfully developing and commercializing 20+ Complex biosimilars (proteins and monoclonal antibodies) with proven capabilities in:
✓ Accelerated development timelines
✓ Global regulatory approvals
✓ International technology licensing and partnerships
✓ Complex biologics from development to commercial launch
This experience enables us to deliver de-risked biosimilar programs with confidence and speed.
Our Integrated R&D Platform
As a fully integrated biologics development partner, we support programs from target validation to regulatory filing, with a focus on quality, scalability and GMP readiness.
Our Service Capabilities Include:
- Late Discovery & Feasibility Studies – Target validation, construct design and expression system selection
- Cell Line Development – Stable, high-yielding clones for both microbial and mammalian platforms
- Process Development – Upstream and downstream optimization for commercial-scale manufacturing
- Analytical Development – Comprehensive characterization, comparability and biosimilarity assessment
- Non-GMP to cGMP Manufacturing – Scalable production to support preclinical through clinical supply and IND filing
Our Core Expertise
Our expertise covers mammalian and microbial systems, with optimized bacterial fermentation (E. coli) and mammalian cell cultures, primarily CHO (Chinese Hamster Ovary) cells.
Mammalian Expression (CHO)
Our mammalian platform supports complex, glycosylated biologics, including monoclonal antibodies and Fc-fusion proteins.
- CHO cell line development and optimization
- Advanced bioprocessing for glycosylation control
- Post-translational modification profiling
- Biosimilarity and comparability frameworks
Microbial Expression (E. coli)
Our microbial platform is optimized for non-glycosylated proteins, including growth factors, cytokines, enzymes.
- High-density bacterial fermentation
- Cost-effective production models
- Rapid development timelines
- Established purification and refolding strategies
Therapeutic Focus Areas
Provis focuses on biosimilar development across multiple high-impact therapeutic areas:
- Oncology – Monoclonal antibodies and targeted biologics
- Metabolic Disorders – Hormone therapies and enzyme replacements
- Rheumatoid Arthritis & Autoimmune Diseases – Anti-inflammatory biologics
- Bone Health (Osteoporosis) – Bone metabolism regulators
Our Business Model
In-House Development + Strategic Partnerships
- Provis-Led Development – Economical production processes, extensive analytical characterization and regulatory strategy development completed in-house
- Partner-Led Commercialization – Collaboration with biopharmaceutical companies for clinical development, regulatory approval and market access
This model enables faster time-to-market, reduced development costs and shared risk while leveraging our technical expertise and your commercial capabilities.
Let's Advance Global Biosimilar Access Together
Partner with Provis to accelerate your biosimilar portfolio with proven technologies, comprehensive development support and a shared commitment to expanding patient access to life-changing biologics.