FOR IMMEDIATE RELEASE
Contact: Elia D. Cossis
SPI USA, Inc. and Omnia Biologics, Inc.
Sign Collaboration Agreement
BALTIMORE (September 19, 2005) -- SPI USA, Inc. (www.usaspi.com) announced today an agreement to provide biotechnology and pharmaceutical consulting services for Rockville-based Omnia Biologics, Inc., (www.omniabiologics.com), which specializes in customized manufacturing for the development of vaccines, gene therapeutics, and biodefense products.
“We are delighted to collaborate with Omnia Biologics Inc. in providing supporting consulting services for the development of biological products. Omnia's expertise in gene therapy and availability of a BSL-3 production facility brings significant potential for the development of novel product candidates”, said Dr. Antonio Moreira, CEO of SPI USA, Inc.
SPI USA will provide consulting services in the following areas:
• Technical details of all upstream and downstream process development, process optimization and process validation projects
• Discussion on facilities, equipment, process, documentation, training and auditing as they relate to CGMP compliance, regulatory requirements and validation requirements
• Design, preparation and review of documents in support of 21 CFR CGMP compliance, including SOPs, Master and Batch Production Records, validation protocols and validation reports
• Other areas by mutual agreement.
“SPI USA 's deep experience and highly respected expertise in training, process review, and evaluation related to GMP compliance and bio-pharmaceutical drug development make them an ideal partner in assuring Omnia's dedication to quality principles” commented Dale VanderPutten CEO of Omnia Biologics, Inc.
SPI USA Inc., whose consulting staff includes Dr. Antonio Moreira, Vice Provost for Academic Affairs and Professor of Chemical and Biochemical Engineering at UMBC, provides highly specialized consulting and training services such as those listed above, to organizations worldwide in the biotechnology and pharmaceutical sectors. SPI USA, Inc. also delivers customized and in-house training seminars on topics such as CGMPs, GLPs, Medical Devices, Bio-production and more. SPI USA is headquartered at the University of Maryland, Baltimore County 's research park, bwtech@UMBC.
Omnia provides customized manufacturing and process development solutions for the development of vaccines, gene therapeutics, and bio-defense products. Omnia has a small-scale BSL-3 production facility expandable to be able to handle a wide variety of products and offer complementary services.