Retrovir introduction at Dartford (1986), pt 1 of 2

the introduction of a new pharmaceutical entity onto the market is a complicated process requiring considerable work reactions that transform raw material into active ingredients under carefully controlled laboratory conditions are scaled up to Industrial proportions how will they work on a large scale how tightly controlled must they be the active drug must be made up so that it can be presented to patients will tablets capsules or liquid be best and in what dosage formal testing procedures standards and specifications for the raw materials active ingredients and final product must be established Protocols are prepared for regulatory authorities and Commercial decisions present themselves what is the marketing strategy will the drug be released worldwide or territory by territory what about packaging support materials and so on the company must establish the supply of raw materials for manufacturer and how to store and distribute to the active intermediaries and final product introducing a drug normally takes years with retrov it was a different story on September the 19th 1986 a double blind clinical study to evaluate retr was stopped because it was obvious that the drug was effective in reducing mortality in patients welcome decided that its introduction was a top priority the active ingredient in retr is zidovudine zidovudine is manufactured from the basic raw material thymidine by a complex multi-stage process Barry orok Works in primary manufacturing at Dartford in September 1986 uh we began to investigate the process um and to investigate the plant requirements for that process to enable us to begin manufacturing January 1987 um this involved quite major modifications to our existing plant the unique thing about the plant is that we we we try and keep it as flexible as possible so that we can reconfigure it to cope with different products and that enables us to make a wide variety of different chemicals in the area we needed a massive amount of engineering work to actually enable manufacturer to begin in January staff from the chemical division engineering divisions and the development Laboratories were all brought together in Project teams to coordinate all efforts most of the engineering work was completed by Christmas uh 1986 but uh some work did go over the Christmas period And it did require that a lot of people spent most of their Christmas working within the division and didn't get to see a lot of their families the zidovudine goes from primary manufacturing to tablet manufacturing to be put into capsules Dave lemon worked on the project the decision was made that we would launch on a particular date and then we all moved Heaven and Earth to make sure that we we met that date and that's in fact I think uh from the date that was originally given to us I think we we in fact launched a couple of months beforehand first we heard of it was last September it was suggested that we would have to go into Capal production we bought in captal filling equipment captal weighing equipment and captal banding equipment we had to get that very very quickly the normal lead times has been about 6 months and in most cases the equipment was delivered within 3 months we then had to commission it and get it going so there was a lot of hours put in by everybody engineering staff and so on we had to build new areas even I think everybody got involved in it with a Goodwill that's from The Operators upwards they they all assisted uh they all helped because it was new equipment it was the most modern equipment that was available and that helped as well