REGULATORYSTRATEGY& SUPPORTDISCOVERYPRODUCTDEVELOPMENTSCALE-UP & cGMP
MANUFACTURING

Medical & Pharmaceutical Development Services
Southwest Research Institute® (SwRI®) is anonprofit contract research and development
organization committed to advancing
revolutionary pharmaceuticals to the clinic. We
offer comprehensive small-molecule, medicaldevice, and biologic development services under
our current FDA license. Our facilities are FDA
inspected, conform to ISO 9001:2015 and ISO
13845:2016, and can support clinical developmentfrom discovery through cGMP manufacturing. We
specialize in developing enabling technologies tomeet our clients’ needs.

Small molecule docked in a protein

Small Molecule Development

Our medicinal chemistry team can perform highthroughput virtual screening with Rhodium™,
explore the chemical space, and synthesize
analogues to optimize target and develop a leadcompound. Rhodium™ is an award-winning,
unbiased in silico docking platform for discovering
new chemical scaffolds.

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Weights

Input

Data-driven Drug Design

Modern predictive algorithms can assist in
development-unique capabilities. Whether
developing an algorithm that can rapidly screenthousands of MRI scans to assist in cancer detection
or better process large datasets of sequencing data,
our team can help develop the tools needed
to succeed.

Medical Devices & Bioengineering

SwRI has extensive expertise in medical device
design prototyping, and testing. Our broad
knowledge base includes regenerative medicine,tissue engineering, wound healing, stem cellresearch, biosensors, nanotechnology, biomaterials, and additive manufacturing.

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wnySummation

Non-linearfitting

Rhodium™
ML Score
Output3D-printed bioreactor scaffolds
for cell expansion

Production and manufacturing at SwRI is limited to the researchand development phase of product development in preparation
for transition to a third party for commercial production andmanufacturing.
For more information on our Discovery, Regulatory Strategy, Drug
Product, or Manufacturing services, please visit
pharmdev.swri.org

Regulatory Strategy & Support

Managing the risk of emerging pharmaceutical programs
through IND filing can be difficult for companies. Our
project management team can assist with identifying
gaps in a pharmaceutical program, planning pivotal
studies, setting up meetings with the FDA, coordinating
the development of key analytical methods for phaseappropriate product specifications, and preparing andsubmitting IND documents.

Drug Product Development

As an innovator in microencapsulation, our team canhelp develop specialized formulations of small-moleculeor biologic API to increase stability, modify for targeted
delivery, or achieve extended release. We are also
experienced in developing implantable drug deliverysystems.

Spinning disk for
microencapsulating APIs

Total synthesis ofscopolamine

Small Molecule cGMP Manufacturing

Our process chemistry team can rapidly develop newscalable routes for API or kilo-scale cGMP production. Our
team can develop new chemical technologies for advanced
manufacturing so that an API can be commercialized
efficiently.

Biological cGMP Manufacturing

SwRI has developed a novel perfusion-based bioreactor
platform technology for adherent cell expansion, cellderived biologics manufacturing, and CAR-T cell therapy,
including effective selection, activation, and transduction.
SwRI also is experienced in the translation, scale-up, andmanufacturing of various biologics such as antibodies,
nanoparticles, biomaterials, and vaccines.
Antibody
immunoglobulin

We welcome your inquiries.
For more information, please contact:
Darrel Johnston, PMP

Director		
210.522.2160
darrel.johnston@swri.org

pharmdev.swri.org
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Southwest Research Institute® is a premier independent, nonprofit research and development
organization. With eleven technical divisions, we offer multidisciplinary services leveraging
advanced science and applied technologies. Since 1947, we have provided solutions for some of
the world’s most challenging scientific and engineering problems.
An Equal Employment Opportunity/Affirmative Action Employer
Race/Color/Religion/Sex/Sexual Orientation/Gender Identity/National Origin/Disabled/VeteranCommitted to Diversity in the Workplace

210.522.2122
ask@swri.org

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