Services & Solutions
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CMC-Product Development & Manufacturing
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Product Development
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Clinical Trial Material (CTM) Manufacturing
Robust capabilities supporting preclinical to Phase II supplies
Clinical Trial Material (CTM) Manufacturing
For early phase clinical trial materials, choose a product development team focused on scalability and performance
Frontage brings a team of leading development scientists with hands-on experience in designing formulation, finished products and manufacturing processes. We have the equipment needed to model processes on the bench and pilot scales for technology transfer to large-scale manufacturing. We complement these capabilities with our good manufacturing practices (GMP), clinical trial materials (CTM), and manufacturing areas for preclinical, Phase I and II clinical supplies.
Formulations
Frontage’s formulation development and CTM manufacturing team designs formulations for targeted delivery of a therapeutic and then develops GMP manufacturing processes to ensure a high-quality product is produced for clinical trials. We develop finished products supporting IND, NDA filings and generic ANDA filings. Our facilities have been designed for flexibility, as we offer a variety of dosage forms and the ability to handle highly potent compounds and DEA-controlled substances.
Manufacturing Services – Novel Drug, Generic Equivalent, and Consumer Health Products
- Stability evaluation of prototype formulations in select container closure systems for lead formulation and commercial stability program management
- Formulation development followed by process optimization studies for scale-up batch manufacturing incorporating Quality by Design principles
- Prototype manufacturing
- Regulatory-ready documentation (eCTD format)
For early phase clinical trial materials, choose a product development team focused on scalability and performance. Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists.
Specialized Capabilities
- Potent compound handling for occupational exposure levels down to 1μg/m3 (or Safebridge Category III)
- DEA licenses for analytical testing and manufacturing (Schedules I-V for analytical and manufacturing)
| Dosage Form | Batch Size | Product Type |
| Oral Solid | 0.5Kg – 30Kg | Neat API fill in capsules and vials Tablets Capsules Solubility enhancement |
| Sterile | 500mL – 20L | Aseptically-filled, stoppered vials using disposable mixing and filling technology Ophthalmic solutions, emulsions and suspensions in 3–piece PE bottles Lyophilized powder for injection |
| Semi-Solid | 0.5Kg – 300Kg | Creams, ointments, gels, and lotions Oral solutions and suspensions |
| High Potency | Up to 10Kg | Neat API fill in capsules and bottles Oral solid/semi-solid/liquid compounding |
Facility
- 35,000 sq ft
- Grade C formulation suites
- Grade A/B (class 100, and 10,000) Clean rooms
- Stability Chambers+8°C
- GMP warehouse
- Walk-in frozen storage -20°C
- Walk-in cold storage +2°C to +8°C
Equipment
- Semi-automated/automated vial/bottle filling, capping, and sealing machine
- Sterilizers
- Lyophilizer
- Table Press
- Roller compacter
- Tablet Coater
- Capsule filler
- High shear granulators
- Microfluidizer
- Fluid Bed Processor
- Comill
- Lyophilizer: LyoStar 3
- Lyophilizer: Millrock LD85
- Spray Dryer
- Negative Pressure Sterile Isolator
- Semi-Automatic Universal Labeling Systems R310 Labeler and Printer
Resources To Consider
CMC – CTM Manufacturing
Strategies and Solutions for Early Phase Formulation Development and…
CMC-Product Development Services
