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VGX™ Animal Health, in collaboration with the team
at VGXI, Inc., has access to a state of
the art facility and manufacturing process that provides the resources
and flexibility necessary to meet both research and commercial
product needs on a real time basis. This collaboration has allowed
the Company to develop and pursue multiple regulatory approvals
in an efficient and cost effective manner. VGX™ Animal Health
has a commercial license to this process, and is in full control
of its future manufacturing needs.
VGX™ Animal Health has
a manufacturing contract with VGXI, Inc. for supply
of its DNA Plasmid research and development needs and for commercial
launch supplies LifeTide™ SW 5 in Australia in 2008. VGX™
Animal Health intends to transfer this manufacturing process to
a larger facility as product demand grows.
The VGXI, Inc. manufacturing staff has over 40 years combined experience
in the areas of Process Development, Quality Control, Quality
Assurance, and Validation of plasmid-based biopharmaceuticals.
Our key personnel has the expertise and skills required to enable
rapid development of products that others would find challenging.
VGXI, Inc. has an outstanding track record of success in meeting goals
and supplying clinical studies.
VGXI, Inc. - manufactured products have passed rigorous reviews by multiple
regulatory agencies, and have passed audits conducted by the USDA,
FDA, APVMA, and private EU regulatory expertss. VGXI, Inc. has manufactured
plasmid products under cGMP conditions for client companies who
have conducted clinical testing in patients in the US and Europe.
The Production Facility
This manufacturing facility and process
incorporate the following key features:
The Quality Systems
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GMP
documentation system in place to assess process control,
monitor and track changes and deviations, document personnel
qualification, and ensure facility and equipment compliance.
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Controlled
raw materials program with specifications, QA release,
complete tracking, and full usage reconciliation. |
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Complete
QC testing and QA release procedures used for in-process,
bulk, final products, excipient, container/closures,
and labels. |
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Facility
designed with one-way flow of materials and personnel.
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Real-time
and accelerated stability protocols are available. |
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VGXI, Inc.
Process Attributes
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Significantly
reduced cost compared to currently available methods. |
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Eliminated
the use of any animal-derived products. |
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Eliminated
the use of organics, carcinogens, flammables, etc. |
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Created
a machine that can continuously produce high quality
lysate at large scale. |
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Developed
a purification process that requires no chromatography
columns or one column step for ultra purity. |
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Implemented
quality standards to meet multiple regulatory agency
requirements. |
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The
Personnel
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Highly trained staff with many years combined experience
producing and testing plasmid-based products. |
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Expertise includes assay and process
research, development, GMP production, and validation. |
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Designed, constructed, and qualified a new facility in less
than 1 year. |
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Implemented new testing methods, production processes, and
quality systems to meet cGMP requirements. |
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Have produced and
tested commercial product for Australian LifeTide™ SW
5 product launch in 2008. |
Requirements
For Effective Plasmid Production |
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Ownership
and control of in-house manufacturing from master cell bank
(MCB) to final drug product fill. |
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Flexible,
purpose-built pilot plant facility used for research, clinical,
and commercial launch production. |
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Key
personnel with expertise allowing for rapid development
of products. |
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Quality
systems in place to meet applicable regulatory requirements.
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A
cost-effective process that has been scaled to meet commercial
needs. |
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Quantitative
methods for contaminants to avoid subjective results such
as “not detectable on gel”. |
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A
track record of success in meeting goals and supplying clinical
studies. |
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