Integrated CRO, CDMO & Proprietary API Process Development

End-to-End Development and Pilot Manufacturing for Complex Modalities
We are an integrated CRO and early-stage CDMO specializing in peptides, oligonucleotides, and biologics, providing end-to-end support from process development through pilot-scale manufacturing. In parallel, we invest in proprietary API process and technology development programs to build scalable manufacturing platforms and future-ready assets. This integrated model allows us to support client programs efficiently while continuously advancing our internal technology base.

Trusted partner for biologics

Mano-Tri Pharma is a research-driven pharmaceutical organization operating within rigorously defined scientific and regulatory frameworks. We support external clients through compliant, scalable, and data-driven development and manufacturing solutions aligned with global regulatory standards.
Our focus is on building repeatable, transparent processes that ensure technical reliability, regulatory readiness, and long-term operational confidence across every engagement.

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Scientific Team & Operating Philosophy

Our organization is led by experienced scientists, engineers, and pharmaceutical professionals with domain expertise spanning development, analytical characterization, quality systems, and regulatory operations.

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Asher John

Chief Scientific Officer

Mila Lucy

Senior Laboratory

Leo Elias

Medical Diagnostics

Iris Eden

Operations Manager

Our Integrated Capabilities

CRO – Process & Technology Development

We support early-stage and advanced development programs through:

API route and process development
Fermentation and expression optimization
Downstream process development and purification
Analytical method development and process characterization
Scale-up and manufacturability assessment

CDMO – Pilot-Scale Manufacturing

Our CDMO services enable translation from development to manufacturing:

Upstream fermentation capacity up to 100 L
Downstream purification and isolation
Supply of material for R&D, preclinical, and early clinical programs*
Process transfer and scale-up readiness

*As applicable to quality systems and regulatory requirements.

Proprietary API Process & Technology Development

In addition to client services, we run internal API process and platform development programs focused on:

Development of scalable, efficient API manufacturing processes
Upstream and downstream platform technologies
Process robustness, yield optimization, and cost efficiency
Creation of transfer-ready processes suitable for licensing, partnerships, or future commercialization

These programs strengthen our technical capabilities and create optional future value beyond service-based offerings.

Why Our Integrated Model Matters

Faster development

Internal platform know-how accelerates client timelines

Lower risk

Deep process understanding improves scalability and transfer success

Innovation-driven

Continuous internal R&D keeps our manufacturing capabilities current

Future-ready

Builds a foundation for clinical and commercial expansion

One Company – Three Integrated Pillars

CRO (Process Development)

Pioneering peptide innovation through precise lead selection, in vitro analysis, and expression optimization.
We ensure purity, potency, and performance across every phase , from concept to clinical scale.

CDMO (Pilot Manufacturing ≤100 L)

Pilot-scale manufacturing enabling smooth transition from development to production, with upstream fermentation capacity up to 100 L and integrated downstream purification.
We support R&D, preclinical, and early clinical programs, with strong focus on scale-up readiness and technology transfer.

Proprietary API Process & Technology Development

Internal programs focused on scalable API process and platform development, strengthening upstream and downstream manufacturing technologies.
These initiatives improve process efficiency, yield, and cost structure, creating transfer-ready processes for future partnerships or commercialization.

Core Capabilities

Upstream: Microbial & Cell Culture

CHO, HEK, and yeast cell lines for biosimilars.
Optimized fed-batch and perfusion systems for scalable production.

Downstream: Purification

Advanced HPLC and chromatography platforms for purity and yield.
Validated processes ensuring consistency and regulatory compliance.

Quality & Regulatory

GMP-certified QC labs with method validation and stability studies.
Comprehensive documentation for global regulatory submissions.

Facilities

Smart Bioprocessing Suites

Equipped with 10L to 100L automated bioreactors and digital control systems.

Integrated Analytical & Validation Labs

Our GLP/GMP-certified analytical spaces are outfitted with advanced instrumentation.

Controlled Storage & Material Management

Comprehensive cold-chain systems and secure storage environments ensure material traceability, product safety.

Case Studies

Monoclonal antibody: IND-ready supply

Reduced time-to-IND by 6 months through parallelized analytical development and accelerated tech transfer.

Recombinant peptide: cost-efficient scale-up

Optimized fermentation and downstream steps cut downstream losses and halved purification costs.

Insights That Keep

October 23, 2025 | By admin