Our Solutions

MANUFACTURING AND ANALYTICAL SERVICES

We provide proof of concept, R&D, clinical and commercial manufacturing that includes liquid-filled capsules, band/sealing technologies, powder and over-encapsulated capsules, topical formulations, and clinical and blister packaging which are manufactured in our purpose-built facility.

FACILITY

Our 30,000-square-foot facility features:

  • 9,500-sq.-ft. warehouse
  • 3,300-sq.-ft. manufacturing area
  • 2,500-sq.-ft. segregated ISO7/8 manufacturing area (capable of handling potent compounds)
  • 1,500-sq.-ft. R&D formulations lab
  • 3,000-sq.-ft. analytical lab.

We have manufactured and/or tested nearly every currently available pharmaceutical dosage form.

MANUFACTURING SERVICES OFFERING

Product Development and Manufacturing Capabilities
  • Formulation and development
  • Process optimization
  • GMP clinical supply manufacturing (Phases I-IV)
  • Scale-up and engineering batch manufacturing
  • Validation batch manufacturing
  • Commercial batch manufacturing
Controlled Substance Manufacturing Capabilities
  • DEA Manufacturing License (Schedules I-V)
Additional Client Support Services
Facility expansion capabilities, including dedicated space and equipment, as required to meet project demands.
  • Man-in-plant
  • Perform supplier audits
Dosage Type and Process Capabilities
  • Liquid-filled hard shell capsules
  • Capsule banding
  • Particle size reduction (wet milling/nano-milling)
  • Powder blending
  • Powder-filled capsules
  • Over-encapsulation
  • Injectable vial filling (pre-sterilized)
  • Solutions and suspensions
  • Gels and creams
  • Clinical packaging (bottles and blisters)
  • Potent product handling

ANALYTICAL SERVICES OFFERING

Development and Validation of Critical Methodologies
  • Cleaning methods for the detection of API on manufacturing equipment
  • API methods for assay/related substance
  • Finished dosage products (assay/degradation, dissolution)
Drug Product Release Testing
  • High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC)
  • Dissolution and disintegration
  • Moisture analysis (Gravimetric and Karl Fischer [KF] Titratron)
Drug Product Release Testing (cont’d)
  • Spectroscopy (Ultraviolet/Visible [UV/VIS] and Infrared [FTIR])
  • Total Organic Carbon (TOC)
  • Viscosity
  • Particle size analysis
    • Malvern
    • Horiba
    • AccuSizer (USP<788>)
Stability Testing
  • ICH environment stability chambers
Controlled Substance Testing
  • DEA Analytical License (Schedules I-V)

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.