Overview
Easy as Phase I, II, III — Clinical Trial Manufacturing at Metrics.
Metrics offers the experience and expertise to handle manufacturing for oral dosage clinical trials. From a teacup-size batch and up, Metrics has the facilities and equipment to deliver materials for Phase I, II and III clinical trials.
From start to finish, we make scale-up seamless.
At Metrics, we can take your drug product from development, to clinical trial, to registration and, depending on the scale, commercialization. Our formulators have a long track record of successful scale-up—and remain accessible to mitigate issues along the way.
We offer full analytical support for your clinical trial batch development and manufacturing, including release testing, stability, microbiology testing and custom analytical development and validation.
Packaging and labeling of all products is available.
We handle specialized products and processes.
Metrics can offer potent and cytotoxic drug handling capabilities for clinical trials. We are also DEA registered for Schedule II-V controlled substances.
Need it fast? We offer fast-track to FTIM.
Metrics can deliver from NCE to first-in-man in four to six months. Learn more about our fast track FTIM services.
Formulation scale up is key.
While Metrics can accommodate a range of commercial manufacturing batches in our own facility, we can also execute formulation scale-up and technology transfer to your chosen manufacturer.
Bring your next CTM manufacturing project to Metrics.
Contact one of our business development professionals and get your next clinical trial materials project started today.
View a comprehensive list of equipment in our manufacturing and packaging rooms.
Capabilities
Your partner for clinical trial materials.
Metrics specializes in manufacturing oral and topical materials for all clinical trial phases I, II and III.
Products include:
- Advanced pellet formulations for sustained, pulsed, modified and delayed release
- Tablets – including coated and matrix
- Powder and bead-filled capsules
- Creams and gels
- Liquids and suspensions
Processes include:
- Blending
- Granulation, compacting and mixing
- Milling and micronizing
- Fluid bed coating and drying (extrusion and high shear)
- Spray drying
- Pellet (bead) and powder encapsulation
- Powder blending and tableting
- Liquid and cream manufacture and packaging
Fast track to clinical trial services are also available.
In addition to clinical trial materials, Metrics also offers scale-up and technical transfer to commercial production.
More thoughtful science from Metrics.
More than just your contract formulation partner, Metrics’ veteran scientists continually explore ways to practice “thoughtful science.” Here is a recent poster related to clinical trial materials.
Facility
A facility that was built for drug product development and CTM manufacturing.
Metrics offers GMP manufacturing areas for development and clinical trial material manufacturing:
- Twelve manufacturing rooms
- Five suites for potent actives (OEL at or above 1mcg/m3 room air)
- Two suites for potent actives with 100% contained equipment (OEL at or above 30ng/m3 room air)
- Our manufacturing area can accommodate large CTM batches if needed
- Three packaging lines
- All facilities are regularly inspected and meet DEA guidelines for Schedule II-V controlled substances
CTM and commercial batch capacity
- 450kg dry blend (one portion)
- 400kg wet granulation (three portions) by high shear granulation/FBD
Full analytical support for your drug product development and CTM manufacturing project is available, including custom analytical methods development and validation, release testing, stability studies and microbiology testing.
Metrics offers seamless scale-up services to commercial manufacture from your CTM batch. Technology transfer is a key scientific offering at Metrics, and our experienced scientists and manufacturing staff will ensure your project is successfully transferred to your specifications.
View a comprehensive list of our North American manufacturing and packaging equipment for clinical trials manufacturing. To learn more about our manufacturing and packaging capabilities in Australia, visit Mayne Pharma.
Click the image to see a larger layout
of the manufacturing facilities in our building.
Equipment
Development-scale manufacturing equipment
The following equipment for solid oral dosages is maintained in our North American facility. To view the equipment list for our Australian facility, where non-solid dosages are manufactured, go to Mayne Pharma.
BLENDERS
Blender; Turbula T2F
Blender, V-shell; 1 pt to 2 qt; Patterson-Kelly
Blenders (2), V-shell; 8 qt; Keith Machinery
Blender, Cross-flow; 16 qt; Patterson Kelley
Blender, Bin-type; 1, 2, 3 cu.ft. (5-30 kg capacity); Flo-Bin
GRANULATORS/MIXERS
Granulator, Vertical-shaft, High-shear (2); up to 1.5 kg; Key KG-5
Granulator, Vertical-shaft, High-shear; 8-25 kg; Fielder PMA 25/65
Granulator, Vertical-shaft, High-shear; 3 kg capacity; Fuji 10-liter
MILLS/MICRONIZERS
Impact mill, Table-top; Fitzpatrick FitzMill Model L1A
FLUID-BED PROCESSORS/DRYERS
Tray Dryer; O’Hara LC II-X
Tray Dryer; O’Hara Labcoat M
TABLET PRESSES
Rotary Presses (2); 10 station, B-tooling, GlobePharma MiniPress II, Piccola PLC-C, SMI Instrumentation
Rotary Presses (3); 16 station, B-tooling, SMI Instrumentation; Manesty Betapress
Rotary Presses (2); 27 station, B-tooling; Manesty Diamond Unipress
Rotary Press; 35 station, B-tooling; Stokes BiLayer Tablet Press
Rotary Press; 36 station, B-tooling; Fette 2200i
Rotary Press; 24 station, B-tooling; Fette 1200i
Single Station Press; Key Minipress SC-2; Globe Pharma MTCM-11
Rotary Press; 14 station, B/D tooling, SMI Compacta, SMI Instrumentation
Rotary Press; 19 station, B-tooling, SMI Compacta, SMI Instrumentation
CAPSULE FILLERS
Semi-Automatic Capsule Filler; 15,000 capsules/hr.; Sizes 00, 0, 1, 3; Elanco Quali-fill Model 8S
Semi-Automatic Capsule Filler; 25,000 Capsules/hr.; Size 0; Shionogi Qualicaps Model 10
HiBar PO510; Hard Gelatin Capsule Liquid Filler
COATING & PRINTING EQUIPMENT
Tablet Pan Coater; 15, 24 and 30 inch diameter pans (<1 kg to 40 kg); O’Hara LabCoat II-X
Tablet Pan Coaters (3); 8.5, 12, 15 and 19 inch diameter pans (200 g to 3 kg); O’Hara LabCoat M & MX
PACKAGING INSPECTING EQUIPMENT (3 packaging lines)
Accumulator Table (3); SureKap Model SKT-36A
Bottle Cappers (3); SureKap Model SK6000-SP
Bottle Labeler (1); NJM-CLI UNI-300V
Cap Retorquer (3); SureKap Model SK600
Cap Torquer; Swanmatic C-300
Conveyor with 2 right angles; SureKap Model SKC4520
Induction Sealer (3); Pillar Model 2KW
Shrink Tunnel; Axon EZ-24-BR
Swift Count/Swift Pack Tablet/Capsule Filler
Tablet/Capsule Bottle Filler (2); 60 bottles/minute; Countec Model DMC-60; Countec Model DMC-120
Unscrambler Table (2); SureKap Model SKT-36U
Portable Induction Sealer; Enercon Compak Jr. and Enercon SuperSeal Jr.
Cottoner (2); Lakso 52
IMA Bottle Unscrambler (1); Model A300
Omega Bottle Unscrambler (1); Model 3D-RP-1-10
Omega Shrink Bundler (1); Model FSB-SL-20
ZEPF Shrink Bundler (1); Model SA 27
NJM/CLI Topserter (1); Model 305VPL
NJM/CLI Minicolt 120 Labeler (1)
Omega Desiccant Feeder; CDF101
Countec Desiccant Feeder; CT-0G-120
Inspector (1); MW Technologies
In-Line Checkweighers (2); Mettler Hi-Speed XE2
Liquid Filler; IMA Fillit and Fillkit
Orifice Seating Device; Tirelli Mini-Nebel
Video Jet Printer; Model 1210
BALANCES/CHECKWEIGHERS
Analytical Balances (numerous); Mettler, O’Haus, others
Checkweigher/Sorters; Key Int’l Model CW-2001, Sade P4 and (2) Sade P2, Qualicaps CW180
TEST EQUIPMENT
Moisture Analyzers (2); Arizona Instruments Compu-Trac Max 2000, MA-35 Sartorious
Powder/Granule Tap Density Tester; VanKel Model 50-1000
Powder/Granule Sonic Sifter (2); Gilson GA-1
Tablet Hardness Testers (5); Key Int’l HT-300; HT-500
Tablet Friabilators (4); Natoli FT400
Tablet/Capsule Disintegration Tester; Van-Kel 71A660A3
MISCELLANEOUS
Capsule Bander, Laboratory-scale; Elanco (Shionogi) Quali-Fill
Capsule Polisher/Selector (2); Key Int’l CP350
Capsule Checkerweighter; Qualicaps CWI-80
Extruder; Luwa EXKS-1
Liquid Filler; Development-scale (5 mL to 2 liter volumes); Accutek Model SAPD1
Marumerizer; Luwa QJ-400
Safeline (2); MC 333
Metal Detector; Metalchek MET 30+
Peristaltic Liquid Pumps (3); Cole-Parmer, MasterFlex
Powder Filler, Laboratory-scale; San Diego Scientific Instruments DOA-2300A
Powder Filler (2); All-Fill SHAA SV600 and All-Fill B-350e
Low Dose Powder Dispenser; Mettler Toledo Quantos QB1
Sifters, Mechanical; MM Industries Vorti-Siv RBF-15 (2), RBF-2; Kason Model 24 (2)
Spheronizer; Luwa QJ230
Tablet Dedusters (8); Key Int’l CP TD101WD
Tablet Thickness Sorter; MW Technologies, RS-200-12
Vacuums, Portable HEPA (12); Nilfisk GS-811, GM-80, 3151
Vertical Drum Dumper; Custom Design & Machine
M.W. Technologies Tablet Sorter; Model RS200-4 (1), Model RS200-12 (1)
Tablet and Capsule Inspection System; M.W. Technologies, Model RB-300
Tablet and Capsule Printer (2); Hartnett Delta, double sided
Jacketed Tank; 350L with bottom agitation
Blister Packaging; EZ Blister II, Thermoformed and Cold-formed
Let’s Get Started
Ask a question. Tell us about your project.
You might be wondering how our capabilities match up with your project. Tell us a little bit about yourself and the clinical trial materials you need, and we’ll get back to you with answers.
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Contact sales (jeff@metricsinc.com) if we need a CDA in place to begin a conversation.