How Do You Choose Partners to Develop the Product?

Manufacturing (50 min)

Good Laboratory Practice includes SOPS, being able to replicate your experiments and results under same conditions. To pass an inspection there must be robust processes in place where you can measure, justify and prove the steps happening in the process. With lots of chemical reactions you need to know what you are getting and supposed to get. From starting materials, environmental conditions, manipulation, labelling, roles / responsibilities.
Good Manufacturing Practice – the key is scale. When you use a natural source such as a plant, you need lot of chemical research to see how you can change it or develop synthetically to reduce environmental damage and loss of species. The development requires good heat, light conditions and for higher volumes. You need to prove that product does not degrade during manufacturing. The drug must still have the same characteristics as it did in the lab. You don’t want it to change composition or you have to start again from beginning.

Once you have completed successful pre-clinical trials for medicines, you will begin to manufacture your product for clinical trials.

If it's a medicinal product, your country may allow pharmacists to manufacture the product in their own store. Some pioneering and successful international case studies:

    1. A Russian couple founded an environmentally friendly toothpaste company, producing next generation toothpaste for the higher priced market.
      http://rbth.com/business/2016/11/01/russian-couples-firm-making-the-world-a-little-cleaner-and-greener_644041
    2. An aspiring medical physicist from Afghanistan, Dr Shakardokht Jafari has developed glass beads that measure radiotherapy dosage more accurately. She is passionate about bringing affordable cancer treatment back to Afghanistan.
      TrueInvivo Glass beads
    3. Beta HealthCare started in Kenya with pharmaceutical development but have expanded into sub-saharan Africa. http://www.betacare.co.ke/about-beta
    4. Andromaco was founded by a Spanish pharma-entrepreneur in Barcelona and managed to open a commercial subsidiary in the US during the 1920s. Laboratorios Andromaco
    5. Biological E, a now international vaccines and pharmaceutical company pioneered the production of heparin in India in the 1950s and also anti TB drugs and vaccines in 1960s and 1970s http://www.biologicale.com/history.html
    6. Bilim Pharmaceuticals in Turkey, founded in 1953.
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