Precision at Scale

Zenth Pharma Manufacturing operates a globally distributed network of Class A/B cleanrooms, modular bioprocessing suites, and sterile fill-finish lines designed for rapid technology transfer and batch-to-batch consistency.

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Small Molecule APIs

Continuous flow chemistry, micro-reactor synthesis, and automated crystallization for high-purity active pharmaceutical ingredients with <99.8% yield consistency.

180MKg/Year Capacity
14Synthesis Lines
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Biologics & mAbs

Single-use bioreactors (50L–20,000L), continuous chromatography, and virus filtration suites enabling rapid scale-up from pilot to commercial manufacturing.

32Bioreactor Suites
8.4ML Annual Volume
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Sterile Fill & Finish

RABS and isolator-based aseptic processing, lyophilization capacity, and automated vial/fill systems supporting vials, cartridges, and pre-filled syringes.

480MDoses/Year
Grade ACleanroom Class

Manufacturing Hubs

Strategically located facilities enable 24/7 production, regional compliance alignment, and optimized cold-chain distribution.

Zenth BioCampus, Cambridge MA
Primary Biologics & CGT Hub
20kL Bioreactors Viral Vector Suites FDA Priority Review Ready
Aevum PharmaWorks, Singapore
APAC Small Molecule & Formulation
Continuous Flow WHO-GMP API + DOS
Zenth Sterile Fill, Berlin DE
EMEA Fill-Finish & Lyophilization
RABS/Isolators EMA/PIC/S 24/7 Aseptic Lines
Aevum Advanced Mfg, Hyderabad IN
High-Volume API & Generic Scale
CDSCO / WHO Cost-Optimized Bulk Synthesis

End-to-End Process Integration

Digital twins, real-time PAT analytics, and automated material handling ensure seamless transition from development to commercial scale.

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Technology Transfer
Standardized protocols, scale-up modeling, and digital twin validation for rapid site onboarding.
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Raw Material QC
NMR, HPLC, mass spec, and AI-driven spectral analysis for incoming batch verification.
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Synthesis / Fermentation
Continuous flow chemistry or single-use bioprocessing with real-time yield optimization.
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Purification & Formulation
Chromatography, ultrafiltration, lyophilization, and sterile filtration integrated with PAT.
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Fill, Finish & Release
Automated aseptic processing, vision inspection, batch record generation, and QA sign-off.

Certifications & Standards

Every facility operates under rigorous quality management systems aligned with global regulatory expectations.

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FDA cGMP
21 CFR Part 210/211 compliance with zero critical observations in last 5 inspections
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EMA GMP
PIC/S certified sites with regular EudraLex Volume 4 audits
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WHO-GMP
Prequalification pathways for vaccines, biologics, and essential medicines
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ISO 13485 / 9001
Integrated QMS covering design control, risk management, and supplier audits

Green Pharma Manufacturing

Reducing environmental impact without compromising yield or compliance through closed-loop systems, solvent recovery, and renewable-powered facilities.

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Solvent Recovery

On-site distillation and membrane separation reclaim >92% of organic solvents for reuse in synthesis cycles.

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Zero-Carbon Sites

3 of 6 manufacturing hubs operate on 100% renewable energy with smart HVAC and waste-heat recovery.

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Single-Use Waste Reduction

Polymer recycling partnerships and reusable bioprocessing hardware reducing landfill output by 68% YoY.

Secure Manufacturing Capacity

Connect with our commercial operations team to discuss CDMO partnerships, technology transfer, or dedicated line allocation.