CTM Manufacturing

Robust capabilities supporting preclinical to Phase II supplies

Discovery
Drug Development
Product Development & CMC
Clinical Services
Central Laboratories

Clinical Trial Material (CTM) Manufacturing

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.

Get in touch with our CMC services experts for a quote. 

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
  • 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