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

  • Laser Diffraction Particle Size Analysis
  • 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 Solvents
  • Excipient Compatibility
  • Melting Point
  • Glass Transition Temperature (Tg)
  • Decomposition
  • Purity Analysis
  • Aqueous Solubility f(pH)
  • Forced Degradation
  • Tablet Friability
  • Tablet Disintegration

At UPM, customized development programs are structured to integrate strategic process development and scale-up, eliminating the need for costly reformulation at later stages.

Pre-Formulation equipment

  • Thermogravimetric Analyzer (TGA)
  • Differential Scanning Calorimetry (DSC)
  • Particle Size Analyzer by Laser
  • FT-IR
  • Static Humidity Chambers
  • R&D Stability Chambers
  • Flodex-Flow Measurement
  • 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 50 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 Drying up to 50-400g 
  • Diosna P 1-6 High Shear Lab Mixer
    0.25, 0.5, 1, 2, 4 liter stainless steel vessels
    Reproducible mixing and granulating
  • PK Blendmaster V-Blender
    0.5, 1, 2 and 4 Shell Sizes (Quart)
    25 rpm blender speed
  • Vector Freund LCDS Hi-Coater
  • 0.5, 1.5 and 2.5 liter pan sizes
  • 35-1000g capacity
  • Spray gun rate 5-30 ml per minute
  • M&O Perry Accodil Model FC
    Fills from 2mg to 250 g
  • Styl'One Single Station Tablet Press Rotary Tablet Press Simulation                                                  Up to 5 Layers with 3 Unique Powders

UPM views BREVI-BATCH® as an essential tool in making decisions regarding investment of research funds. By utilizing the UPM processing platform, organizations are able to decide commitments earlier in the process.