2 
5. The different conditions of the industrial scale make it less appropriate 
to attempt to categorise proposals according to defined levels of containment. 
A preferable approach is to integrate the biological characteristics of the 
system with the physical characteristics of the plant, to review arrangements 
for the running of the plant for example by reference to an operations manual 
and to make an overall assessment for acceptance or rejection of the proposal. 
Acceptance may, of course, be qualified provided appropriate changes are made 
to eliminate an unacceptable feature or to decrease any associated hazard. 
6. Vaccine production and antibiotic production are two well-established 
industrial biological processes which provide the design of plant and the 
operational experience appropriate for the large-scale culture of a self- 
propagating product of genetic manipulation and the subsequent extraction 
of its active principle. There is little to distinguish these processes from 
those of chemical engineering in which effective design, efficient fabrication 
and skilled operation provide a very high degree of containment. 
7. When considering proposals which involve 'scale-up' the GMAG will wish 
to have information additional to that usually required on the usual proposal 
forms. In addition to such details as the nature of the biological host/vector 
system and the inserted DNA sequences the GMAG will ask for information on the 
extraction of the product, details of the building and fermentation plant (such 
as the structure and operating procedures), the disposal of waste, emergency 
procedures, the training of operatives and safety procedures (including details 
of the local safety committee, biological safety officer and medical supervision). 
8. Proposal for large scale work that have implications for commercial 
property or patent protection may be submitted under the Group's special 
confidentiality scheme. Further details of this scheme are obtainable from 
the Group's secretariat. 
9. The GMA£ Secretariat at the MRC Headquarters, 20 Park Crescent, 
London WIN 4At, will give advice to any person wishing to submit a proposal 
involving scale-up to the Group. 
November 1979 
[2741 
