THE GERM-FREE PROCESS AND TECHNOLOGY

Stage 01
Ovagen use SPF birds and place them in a special Isolator. The egg is removed from the Shell Gland/Uterus under strict Germ-Free conditions. The first generation GF eggs are premature and require special conditions which are provided in an Incubating & Hatching Isolator. Once hatched the chicken is moved to a Large GF Mobile Isolator (~35 birds). From this stage onwards, GF eggs are laid naturally by hens.

Stage 02
Germ-Free eggs are hatched in small Isolators and the young GF chicks are then transferred to large GF rooms for rearing and breeding. In these rooms, chicks grow into adults and breed naturally enabling the commercial production of GF eggs / products. The second and subsequent generations of GF eggs are laid normally and are fully mature (do not require special incubation conditions) ready for customer use. In the GF rooms, hens and cocks are housed in traditional deep-litter system (with automatic nest boxes) under fully aseptic conditions. Feed is sterilised by irradiation.

Stage 03
The Germ-Free eggs are used for primary cell culture (PCC) vaccine production, research and development, whole egg vaccine production or adventitious agent testing.

WHAT IS GERM-FREE?

• No gut flora, no skin bacteria/fungi/parasites
• Exceed all SPF standards for viruses & mycoplasma
• Unique production system (ultra-level of biosecurity) for management of flocks
• Not susceptible to disease outbreaks (full biosecurity - even against HPAI)
• Assured continuity of supply

• GF mammals are derived by caesarean section into sterile environment
• GF birds are derived by similar process removing the egg before it enters the cloaca. SPF birds are used as parents
• The first-generation GF egg is premature and requires specific incubation conditions

• HEPA filtered positive pressure air
• Sterilised bedding, food and water (gamma irradiation)
• Housed in specialised isolators or biosecure rooms (up to 5,000 birds)
• Traditional deep-litter system of housing (no cages)
• Keep birds and eggs free from infection (maximum biosecurity)
• Highly automated system including egg collection & packing
• Daily monitoring for absence of bacteria (also provides instant warning of any loss of SPF status)

• GF chickens breed naturally, similar productivity to SPF parent stock
• Hatchability meets or exceeds SPF (mean hatchability for GF >92%)
• Exceed USDA Memo 800.65 and European Pharmacopoeia requirements
• cGMP compliant

THE BENEFITS OF GERM-FREE OVER TRADITIONAL SPF

• 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
• Increased risk of adverse events
• Interference with adventitious/ extraneous agent tests
Results in loss of R & D productivity and even loss of vaccine batches

• Results in lack of continuity of supply

• Completely free of infection
• Loss of SPF status detected before sending to customer (unlike conventional SPF eggs)
• Fully compliant with cGMP