Clinical Manufacturing Services

With a long history as a trusted pharmaceutical manufacturer, every project at UPM receives the highest quality with the greatest efficiency and speed possible. We are capable of supporting your clinical trial needs over a wide range, from a few hundred units to over a million units. 

UPM provides cGMP clinical trial materials for phase I, II and III tablet, capsule and semi-solid products

Every aspect of work at UMP is supported by the depth and breadth of our experience. We are focused on attention to scientific detail and overall quality. UPM's experience ensures our customers receive the highest-quality clinical trial materials and that they will be manufactured and delivered on time.


SERVICES

State of the art equipment in all areas of clinical manufacturing provides UPM’s clients with the utmost in accuracy and speed. Our tablet presses have individual capabilities such as B or D tooling, small-scale manufacture for R&D, and capacities up to 170,000  per hour. With cutting-edge encapsulation equipment, we are able to produce as few as 100 capsules or as many as 100,000 capsules per hour. UPM can also handle, semi-solids such as creams and ointments. From proof of concept to feasibility, early-to late-stage trials, and clinical-to large-scale batches, UPM's processes reduce the overall drug development timeline and accelerate time to clinic with: 

 

  • Direct API Fill Into Capsules
  • Single or Bi-Layered Tableting
  • Encapsulation and Over-Encapsulation
  • Encapsulation of Powders, Granules, Tablets, and Combinations
  • Coating for Beads and Tablets
  • Granulation and Fluid Bed
  • Extrusion and Spheronization
  • Roller Compaction
  • Particle Size Reduction
  • Large and Small Batch Blending and Mixing
  • Precision Weight Sorting
  • Packaging & Labeling


Specialty Services

Look to UPM for the highest quality specialty applications. Our capabilities include variable capacity high speed coating equipment, precision processing of fine powders, pellets, granules and crystals, production of high-density, low-excipient granules, and uniform, durable compaction. We provide our clients with versatile applications for every purpose and every step in the clinical manufacturing process. Among the many applications we feature are:

  • Mini-Tablets
  • Orally Disintegrating Tablets
  • Bi-Layer Tablets
  • Controlled Humidity Suite
  • DEA-Controlled Substances (CII- CV) Manufacturing


Xcelodose Encapsulation System

Key Features

  • Precision dosages as low as 100µg per capsule
  • Fully automated, humidity controlled enclosed system
  • High-potency, direct fill without excipients or bulking agents
  • Accelerated drug development cycles 

UPM Pharmaceuticals offers encapsulation services using the state-of-the-art, highly precise xcelodose system for clinical trial supply manufacturing. We use this technology’s CFR 21 Part 11-compliant software to accurately record factors such as the weight of each capsule for the monitoring of batches and individual capsules.

An Advanced System Recognized Worldwide

The Xcelodose system is a precision powder micro-dose system and automated encapsulator with a fill range of 100 micrograms to greater than 100 milligrams.  UPM leverages its advanced Xcelodose suite, establishing a unique ability to provide manufacturing services for early stage clinical trials.

Signature Capabilities of the Xcelodose 600S System

UPM creates manufacturing batches for clinical trials  a service that has never been easier or more precise with the Xcelodose 600S automatic precision powder micro-dosing system.

UPM’s Xcelodose suite uses the pepper-pot principle to dispense dose weights as low as 100 micrograms, which allows you to precisely, accurately and repeatedly fill capsules and other small dose containers with active substances alone, without excipients or bulking agents (for the majority of API’s). Most blends, or formulated products, can also be filled without segregation.

This technology enables you to directly fill active pharmaceutical ingredients into capsules at a rate of several hundred capsules per hour. By eliminating the need for excipient compatibility and pre-formulation activities, first-in-human and first-to-market times can be dramatically shortened.

Implementing the Xcelodose system, UPM can shorten drug development time and speed up time to first-in-human clinical trials.

Robust Features of the Xcelodose 600S System

Precision dosing and optimized filling are just two of the robust features that make the Xcelodose 600S System the choice for pharmaceutical research and development concerns all over the globe. Other innovative features of the Xcelodose system include:

  • Highly Consistent Dose Accuracy – Programmable dispensing of dose weights as low as 100 micrograms; Recording allows traceability for GMP requirements
  • Filling Pure Drug Alone – Simplifying analytical and stability protocols and reducing waste
  • Filling Most Blends – Without segregation
  • Handles Moisture-Sensitive Compounds – Relative humidity (RH) in the dispensing area can be reduced to < 5% and controlled to +/-1% of desired RH
  • Automatically Optimized Filling Process – Compensates for any variability in drug powder properties
  • Simple User Interface – Continuous data display and on-screen instructions with full audit trail traceability

Xcelodose 600S System Specifications

  • Handling – Fully-automatic capsule handling and filling
  • Throughput – 600+ capsules per hour                                  Long runs and greater fill weights
  • Dose Form – Capsules size 00 to 4
  • Dispensing System Footprint – Length: 600mm Width: 400mm Height: 330mm
  • Material Type – Bead, Granule and Powder
  • Dispensing Range –  As low as 100µg
  • Weighing Accuracy – Typically 1-2% RSD 1% when using stored proven fill method
  • cGMP Compliant – Yes, with extended validation pack available as an option

UPM’s Xcelodose suite delivers precision accuracy at high speed with unprecedented ease of control. Let UPM Pharmaceuticals accelerate your company’s drug development cycles and increase profitability with the Xcelodose 600S.

1.5 Million Capsules Filled at UPM and Counting…