THE BENEFITS OF GERM-FREE OVER TRADITIONAL SPF
Conventional and SPF eggs have inherent disadvantages
- They carry bacterial contamination, outside and inside the shell (2 to 10% of eggs carry internal contamination)
- Decreased hatchability
- Potential contamination of Master / Working Viral Seeds
- Contamination of PCC / CEF vaccine production lots
- Contamination of other products e.g. antibodies
- Increased risk of adverse events
- Interference with adventitious / extraneous agent tests
Results in loss of R & D productivity and even loss of vaccine batches
Susceptible to infectious disease / loss of SPF status
- Results in lack of continuity of supply
Germ-Free eggs from Ovagen provide the solution
- Completely free of infection
- Loss of SPF status detected before sending to customer (unlike conventional SPF eggs)
- Fully compliant with GMP
Comparison of SPF and Ovagen GF Eggs
| Criteria |
SPF |
GF |
| Susceptible to internal bacterial contamination |
Yes
(Typically 10% of eggs) |
No |
| Risk of vaccine batch loss associated with contamination |
Yes
(Up to 20% of batches) |
No |
| Financial Rationale |
Poor |
Compelling
(ROI > 100%) |
| Bio-Security |
Low |
High |
| Susceptible to disease epidemics (e.g. Avian Influenza) |
Yes |
No |
| Delay in identifying loss of SPF/Regulatory Compliant status |
Yes |
No |
| GMP Compliant |
No |
Yes |
| Suitability for high value, specialist use (Master Viral Seeds, PCC etc) |
Low |
High |
|
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NEW FACILITIES
New Facilities (2500msq)
- First generation germ-free flocks
- Isolators, Incubators
- Laboratories
- Pilot scale (25%) commercial production
- R&D
- Head Office
Lower Floor Provides:
- SPF flocks
- Large Germ-Free (GF) Isolators
- GF suite for flock of 1000 birds
- GF 'space' suits & decontamination showers
- GF feed handling
- GF egg collection & packaging
Upper Floor Provides:
- SPF showers
- Incubating/Hatching Isolators
- Transport Isolators
- Laboratories & QA
- Head Offices
- Site BMS & IT facilities
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