Proof of Concept

Proof of concept services at UPM are widely recognized for speed, precision and innovative thought across a full spectrum of studies. Based on our client needs, we evaluate a number of parameters for development and manufacture of specific API (active pharmaceutical ingredient) dosage forms based. Brevi-Batch is a cost effective development approach ideal for clients in search of high quality, proof of concept. With a significantly smaller scale than most small-scale R&D formulation batches, Brevi-Batch conserves valuable R&D API using equipment designed for fast set-up, use, and clean-up.   UPM’s R&D formulation center features separate space from the GMP manufacturing areas, including safety downflow hoods, raw material inventory and controlled storage conditions.

Pre-formulation Capabilities

  • Particle Size Analysis(by laser)
  • Differential Scanning Calorimetry(DSC)
  • Thermal Gravimetric Analysis(TGA)
  • Osmolality
  • Coulometric Moisture Analysis
  • HPLC with ELSD
  • Dynamic Moisture Sorption
  • Moisture Sorption Isotherm
  • Surface Tension
  • Heat of Solution
  • Ph/PKa
  • Flame Photometry
  • Solubility
  • Microscopy
  • Equilibrium Solubility in Various Solvents
  • Exipient Interactions / Compatibility
  • Melting Point
  • Glass Transition
  • Decomposition
  • Purity Analysis

Pre-Formulation equipment

  • Thermogravimetric Analyzer
  • Differential Scanning Calorimetry
  • Particle Size Analyzer by Laser
  • FT-IR
  • Static Humidity Chambers
  • R&D Stability Chambers
  • Flodex
  • Bulk/Tap Density
  • Sonic Sifter
  • Powder Dispenser

UPM Team Advantages

  • Extensive equipment train to carry out essential testing
  • Comfortable with API sparing techniques
  • Experience in method development and transfer techniques
  • Dedicated team of analysts, formulators, and manufacturing associates who will work closely together from early stage development to GMP scale up
  • Peer-to-peer communication on a consistent basis
  • On site scale up for clinical and commercial supply
  • Data and client confidentiality from relationship on set

BREVI-BATCH Processing Platform

BREVI-BATCH® is a UPM trademark processing platform used for solid dose mini-scale R&D formulation development batches. BREVI-BATCH® is ideal for clients seeking to produce low-cost, high quality proof-of-concept results that will conserve valuable R&D API (active pharmaceutical ingredient).

Using the mini-scale processing equipment, the BREVI-BATCH® target batch size is 100 – 500 grams, a scale significantly smaller than most small scale R&D formulation batches. The specialized equipment is designed for fast set-up, use and clean-up. And, given the scale of the equipment, all processing can be done under containment conditions for potent APIs.

BREVI-BATCH® Equipment Highlights:

  • Quadro Comill U5
    40g sample size
    Over 200 different screens and different impellers
  • Caleva Screen Extruder
    Screen from 0.5-2.5mm
    Smallest batch size extruded is 5g
  • Caleva MBS Spheronizer 120
    Capacity from 10 to 150 g
  • L1A Fitzmill
    Minimal sample size of 5g
    Process wet or dry products
  • Vector Freund TFC-Lab Micro Roller Compactor
    Minimum sample size of 5 g
    Up to 1kg per hour working capacity
  • Mini Glatt
    Top Spray 50-400g
    Bottom Spray 50-200g
    Standard container for 50-350g and MicroKit for 2.5-50g
  • Diosna P 1-6 High Shear Lab Mixer
    0.25, 0.5, 1, 2, 4, 6 liter stainless steel vessels
    Reproducible mixing and granulating
  • PK Blendmaster V-Blender
    0.5, 1, and 2 shell sizes (quart)
    24 rpm blender speed
  • Vector Freund LCDS Hi-Coater
  • 0.5, 1.5, 2.5, 4, 6, and 8 liter pan sizes
  • 100-500g capacity
  • Spray gun rate 5-30 ml per minute
  • M&O Perry Accodil Model FC
    Fills from 2mg to 250 g

UPM views BREVI-BATCH® as essential to our clients, specifically those attempting to make the best and most cost effective decisions about the investment of precious research funds. By utilizing the UPM processing platform, organizations are able to make smaller research commitments earlier in the process.