OneSource provides comprehensive analytical services for biologics development and manufacturing, supporting approximately 95% of required testing in-house. Analytical capabilities at OneSource are designed to support both novel biologics and the highly demanding requirements of biosimilar development.
Biologics development
and manufacturing services
From early-stage biologics process development through commercial manufacturing, OneSource delivers fully integrated biologics CDMO services across microbial and mammalian platforms. Our global biologics drug substance and drug product development center, supported by advanced analytical infrastructure and scalable manufacturing, enables biologics from concept to market with speed, control, and confidence.
Speak with our biologics teamAn integrated biologics CDMO built for end-to-end delivery
Biologics development rarely follows a straight path. Programs evolve, timelines shift, and complexity increases as molecules move from development to commercialization. OneSource is structured to support this full lifecycle with a single, integrated platform, including the integration and production of drug-device combination products.
Clients engage OneSource at any stage, including:
- Early-stage development—gene to IND
- Tech transfer for clinical material generation—IND to BLA
- Commercial manufacturing and alternate supply
- Prior Approval Supplement (PAS)
Comprehensive capabilities enable end-to-end programs:
- Process development and process characterization
- Analytical method development and validation
- Product characterization
- Clinical and commercial manufacturing
- Fill/finish and drug device integration
With integrated drug substance development and drug product development and manufacturing at the same site, OneSource eliminates common handoff risks and accelerates timelines.
Supporting the full spectrum of biologics modalities
OneSource supports a wide range of biologics across both microbial and mammalian expression systems.
Microbial Platforms
HOVER TO REVEAL DETAILSMicrobial Platforms
- Recombinant protein products: Enzymes, cytokines, antibody fragments, peptide hormones, and more
- High-yield E. coli expression systems
- Intracellular – soluble and inclusion bodies; secreted products
Mammalian Platforms
HOVER TO REVEAL DETAILSMammalian Platforms
- Conventional monoclonal antibodies (mAbs)
- Bispecific and trispecific antibodies
- Fc-fusion proteins and glycoproteins
- Recombinant proteins
This breadth allows OneSource to support both novel biologics and biosimilars, with demand increasing due to upcoming patent expiries and a growing global biosimilar pipeline.
Analytical capabilities across the biologics lifecycle
- Identifying quality target product profile (QTPP)
- Method development and qualification
- Method transfer and validation
- Bioassays (binding, kinetic, and functional)
- LCMS
- Stability studies and reference standard development and maintenance
- Product characterization for novels using orthogonal analytical methods
- Biosimilarity assessment and reference product strategy for biosimilars
- Raw material testing
- In-process and final release testing methods
Development and process expertise that enables scale
Successful biologics manufacturing starts with robust development. As a premier biologics CDMO, OneSource integrates upstream, downstream, and analytical teams from the outset to ensure processes are designed for scalability and manufacturability.
A core focus is ensuring processes are transfer-ready and scalable, supported by deep gap assessment and structured tech transfer methodologies.
Facilities and infrastructure designed for biologics at scale
Biologics programs at OneSource are supported by a coordinated network of development and manufacturing facilities in Bangalore, designed to move seamlessly from early-stage biologics process development through commercial production. This infrastructure connects upstream and downstream development with large-scale manufacturing and integrated drug product development and drug-device-combination product capabilities, ensuring continuity across the product lifecycle.
Rather than treating development and manufacturing as separate functions, OneSource aligns these environments to enable efficient scale-up, streamlined tech transfer, and consistent execution.
Integrated DS & DP Facility
Global R&D Facility
Sterile Injectable Facility
Penicillin Injectable Facility
Soft Gelatin Facility
Accelerating development with advanced technology platforms
OneSource combines extensive experience, expertise, and advanced technologies to enhance productivity, yield, and manufacturability.
OneSource Technology Advantages
High-titer clone development (8–10 g/L in ~7 days)*
Next-generation E. coli expression with extracellular production*
High-concentration, low-viscosity formulation (~300 mg/mL)*
Perfusion-enabled mammalian systems
These capabilities translate directly into faster development timelines, improved yields, and reduced cost of goods, while also enabling more patient-friendly delivery formats such as subcutaneous administration.
*Service offered in cooperation with external partners.
Integrated drug substance and drug product capabilities
OneSource’s integrated model continues through drug product manufacturing, where biologics are filled into a range of formats.
Drug product formats include:
Vials (liquid and lyophilized)
Prefilled syringes
Cartridges
Pens
Autoinjectors
Because drug product capabilities exist alongside drug substance manufacturing, transitions between stages are streamlined. There is no need for external transfers under controlled-temperature conditions, and scheduling can be aligned to meet program timelines more efficiently. The result is a more controlled, predictable path from bulk drug substance to final product.
The OneSource integrated model enables:
- Reduced tech transfer risk
- Simplified logistics and scheduling
- Faster timelines from DS to DP
- Improved cost efficiency
Quality, Compliance, and Digital Integration
Biologics programs at OneSource are supported by a robust, unified quality framework spanning development and manufacturing. Our commitment to quality excellence is reinforced by a strong regulatory track record, including approvals from major global agencies and a history of successful audits.
Combined with ongoing investments in digitization and data access, these systems provide clients with greater transparency and confidence throughout the lifecycle.
Built to Deliver: Right-First-Time Execution
OneSource’s biologics programs are guided by three core principles:
Integrity
through proven compliance and quality systemsCollaboration
through deep client engagement and strategic supportExecutive Excellence
through right-first-time scale-up and tech transferPrograms are guided by structured governance models, detailed gap assessments, and cross-functional alignment designed to identify risks early and ensure successful scale-up and tech transfer.
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