Clinical Materials Manufacturing

The SwRI Microencapsulation and Nanomaterials Department strives for continuous improvement in providing the highest quality services and products to meet or exceed the expectations of the client.

CAPABILITIES

The Microencapsulation and Nanomaterials Department at Southwest Research Institute® (SwRI®) has more than 60 years of experience in microencapsulation processing, with a staff of more than 50 scientists and technicians. Capabilities include:

• Clinical trial material Phase I–III manufacturing (lyophilized vials, capsules, implants, bulk intermediates, API)
• Pre-IND proof-of-concept studies
• Scale-up productions
• Spray dry and rotating disk atomization
• Solvent evaporation and phase separation
• Controlled release methods (delayed release, mechanical rupture)
• Glove box operations (potent handling, controlled drug substance Class I–V)
• Blending and capsule filling
• Sieving
• Extrusion
• Packaging and labeling of clinical materials
• Analytical support (LCMS, HPLC, GC-FID, particle size, UV-Vis

Rotating disk atomization	Blending	Analytical support

Spray drying	Glove box operations

FACILITIES

M&N Department facilities

The department occupies more than 20,000 square feet of laboratory facilities, including a pilot plant facility equipped with cGMP suites. Additionally, two HEPA-filtered cGMP suites encompass more than 4,000 square feet of production facilities.

cGMP productions can include the use of equipment such as a spray dryer, V-blender, glove box, rotating disk, laminar flow hood, mills and sieves. The department also offers method development and validation for analytical support of cGMP productions.

REGULATORY COMPLIANCE

SwRI's Chemistry and Chemical Engineering Division, which conducts the comprehensive microencapsulation program, has achieved certification to ISO 9001:2000, ensuring compliance with stringent quality control procedures in development, production and servicing.

The Microencapsulation and Nanomaterials Department maintains compliance with the Food and Drug Administration's current Good Laboratory Practices (cGLP) and Good Manufacturing Practices (cGMP).
SwRI maintains controlled substance registration (Manufacturer Schedules II–V, Researcher Schedules I–V) with the Drug Enforcement Administration.

Institute Quality Systems staff members review all supporting data and final results generated from the manufacturing processes.

This flyer was originally published in March 2009. For more information about Clinical Materials Manufacturing, contact Dr. Sandra Drabik, Phone (210) 522-6419, or Joseph Persyn, Phone (210) 522-2691, Microencapsulation and Nanomaterals Department, Chemistry and Chemical Engineering Division, Southwest Research Institute, P.O. Drawer 28510, San Antonio, Texas 78228-0510.

Chemistry and Chemical Engineering Brochures SwRI Brochures
SwRI Publications SwRI Technical Divisions SwRI Home