Clinical Trial Supply Services

Southwest Research Institute guides clients through each phase of the pharmaceutical development life cycle. Expert scientists ensure new drugs meet FDA and CGMP requirements for sourcing, manufacturing, packaging and distribution across the clinical trial supply chain. Clients can use our fully integrated clinical supply services from formulation development, analytical support, scale up to clinical trials and CGMP Manufacturing of active pharmaceutical ingredients (API) and drug products supplied in a variety of final dosage forms.

Clinical Supply Facility Services

A new 21,000-square-foot Clinical Supply Facility will nearly double the Institute’s capacity to support pharmaceutical clients in government and industry. The facility will include dedicated bioengineering production suites with filtered air and low airborne particulate counts to facilitate the production of in vitro stem cells, certain types of vaccines and small molecule therapeutics. The facility will support:

Scale-up for clinical trials
Clinical supplies for API
Clinical supplies for formulated products
In vitro studies

New Clinical Supply Facility

Southwest Research Institute breaks ground on new 21,000-square-foot Clinical Supply Facility.

View Press Release

Laboratory Equipment

The new SwRI facility will feature multiple synthesis labs and hoods, incorporating fully functional equipment necessary for organic synthesis work. These synthesis facilities include over 40 feet of hood space that house numerous eight-line high vacuum and nitrogen manifolds, multiple temperature-controlled stir plates, several block-reactors with J-Kem temperature controllers for running more than 20 reactions in parallel, solid phase synthesis apparatus, rotary evaporators, fast vacuum evaporators, drying ovens, and extensive purification capabilities including automated chromatography systems and automated microwave reactor capability. The labs also possess glove boxes and other containment systems for air-sensitive chemistries.

Using a scanning electron microscope (SEM), SwRI can validate compounds and formulations.

Our analytical labs are equipped with the following instruments:

Bruker 400 MHz with 24 well autosampler nuclear magnetic resonance (NMR)
Powder X-ray diffraction and scanning electron microscope (SEM)
High-performance Liquid Chromatography (HPLC) systems with refractive index (RI), fluorescence and UV diode array detection
Thermal gravimetric analysis (TGA)
Differential scanning calorimetry (DSC)
Particle size distribution analysis (laser light scattering)
Karl Fischer, osmolarity and infrared spectroscopy (IR)
Ultraviolet-visible spectroscopy (UV-VIS)
Total organic carbon (TOC) analysis
Ion chromatography (IC)
Polarimeter for chiral confirmation, Zeta Potential Analysis, and Dissolution testing for Dissolution I through V.
GC-MS and non-destructive imaging support

GMP Manufacturing Equipment

SwRI uses equipment suitable for synthetic transformations, lyophilization, capsule filling, mixing/blending, extrusion, and milling/sieving. The facilities include three pilot plants suitable for CGMP operations up to a scale of 200 liters and temperature ranges from −60 °C to 200 °C. This is an FDA-inspected and ISO 9001:2015 certified facility. Executed in both the SwRI synthesis labs and pilot plant facilities, our expert staff provide several multi-step syntheses, utilizing a wide range of reaction conditions and diverse reagents.

Materials and Bioengineering services include:

Bioengineering production suites
Biomedical device development

Capsule Filling Services & Encapsulation

SwRI specializes in providing solid oral dosage forms, tablets and capsules, for early phase clinical trials. Our capsule filling services fill a niche by providing a customized approach to capsule dosage forms to meet our customer’s needs for their clinical trial supply:

A sachet-filling machine at SwRI measures out powder-based new drugs used in FDA-approved clinical trials.

Variety of capsule sizes (00-5) and formulations (gelatin, vegetarian, enteric)
Batch sizes from 500-500,000 capsules
Low-dosage accuracy down to 0.5 mg
Manufactured in ISO 7 (class 10,000) and ISO 8 (class 100,000) clean rooms
High-potency compounds
Blending of raw materials
Bottling, sealing and labeling
Oral Multi-particulates (Melt spray Congealing and fluid bed coating)
Powder sachet filling
Unit dose vials (lyophilized or dry powder fill)
Clinical supply forecasting services and distribution
Milling and micronization

Technician working a SACF-25 capsule filler

SwRI chemists operate a capsule-filling machine used in FDA-approved CGMP manufacturing of clinical trial drugs.

Other services provided for CGMP manufacturing of clinical trial supplies include: