Clinical Trial Material Manufacturing
CTM Manufacturing
Sterile & Non-Sterile CTM Manufacturing — Preclinical → Phase I → Phase II
SmaBio Labs delivers flexible, quality-focused GMP manufacturing solutions tailored to your program. We combine technical expertise, disciplined execution, and comprehensive quality oversight to support consistent and reliable clinical material.
Supports
- FDA cGMP for Phase 1
- 21 CFR cGMP
- IND
- NDA
- ANDA
- 505(b)(2)
Quality Focused Execution. Reliable Clinical Supply.
- Controlled Processes
- Aseptic Discipline
- Active QA Oversight
- Quality Control and Testing
- Documentation and Traceability
- Consistent Results
Sterile · Phase-appropriate
Phase Appropriate Support for Different Development Phases
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Development Phase
Preclinical
- Feasibility and formulation development for sterile products
- Early sterility risk assessment and process design
- Small-scale batch production for toxicology studies
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First-in-Human
Phase I
- Flexible, small-batch aseptic manufacturing
- Streamlined documentation in compliance with FDA Guidance for Industry - cGMP for Phase 1 Investigational Drugs
- Rapid turnaround to support clinical timelines
- Excellent project management for stakeholder alignment and transparent communication
- Enhanced environmental monitoring and sterility assurance
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Development Expansion
Phase II
- Process optimization and scale-up
- Increased batch consistency and process control
- Phase appropriate method validation and specification establishment
- Stability data generation to support Phase III scale-up
- Alignment with more comprehensive 21 CFR cGMP expectation
Sterile capabilities
Sterile Manufacturing Capabilities
SmaBio Labs supports pharmaceutical, biotech, and medical device sponsor companies with sterile Clinical Trial Material (CTM) manufacturing from preclinical development through Phase II clinical trials. SmaBio Labs focuses on aseptic processing, contamination control, and regulatory compliance to ensure the highest standards of product sterility and patient safety.
Aseptic Processing
- Small-scale sterile batch manufacturing
- Manual and semi-automated filling operations
Sterile Dosage Forms
- Injectable solutions, suspensions and emulsions
- Ophthalmic solutions and ointments
- Sterile devices
Process Development
- Process development and optimization for safety, stability and sterility
- Filter compatibility and integrity testing
- Support for clinical packaging and labeling
Controlled Environment and Infrastructure
ISO 7/8 · ISO 5
- ISO 7/8 Cleanrooms
- ISO 5 Biosafety Cabinets
- Fume Hoods and Laminar Flow Hoods
- Isolators for High Potent API (HPAPI) handling
- Segregated manufacturing rooms
- Monitored warehouse
Non-sterile · Phase-appropriate
CTM Manufacturing for Non-sterile Products
Flexible and scalable solutions for a wide range of dosage forms, ensuring quality, consistency, and regulatory compliance.
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Phase 01
Preclinical
- Small-scale batch production for toxicology and feasibility studies
- Fit-for-purpose analytical methods
- Initial stability assessment
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Phase 02
Phase I
- Rapid, flexible manufacturing of CTM
- Phase appropriate documentation (FDA cGMP for Phase 1)
- Dose escalation and protocol changes
- Packaging and labeling for clinical use
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Phase 03
Phase II
- Process refinement
- Pilot scale-up batches
- Enhanced analytical testing and method qualification
- Increased compliance with 21 CFR cGMP requirements
Non-Sterile capabilities
- Liquid Dosage Forms (Solutions, suspension, emulsions)
- Semi-Solid Dosage Forms (Creams, gels and ointments)
- ISO 7/8 Cleanrooms
- Fume Hoods and Laminar Flow Hoods
- HPAPI isolators
- Segregated manufacturing rooms
- Monitored warehouse