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Continuous Flow manufacturing: Africa’s possibility of leap-frogging Indian API manufacturers

Continuous Flow manufacturing: Africa’s possibility of leap-frogging Indian API manufacturers. Africa Pharma Conference 4-5 June 2019 Prof. Paul Watts. Expectations of continuous manufacturing. Original expectations: use for high value manufacture

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Continuous Flow manufacturing: Africa’s possibility of leap-frogging Indian API manufacturers

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  1. Continuous Flow manufacturing: Africa’s possibility of leap-frogging Indian API manufacturers Africa Pharma Conference 4-5 June 2019 Prof. Paul Watts

  2. Expectations of continuous manufacturing Original expectations: use for high value manufacture • Pharmaceuticals (from discovery to production) • High value fine chemicals Initially the major large-scale industrial driver for the introduction of continuous technology has been safety • Xian Chemicals (China) - 30 tonne/annum nitroglycerine • DSM (Netherlands) - Naproxen (> 100 tonne in 7 weeks) Case studies published showing financial savings of using continuous production (20-30%) But where is continuous manufacturing dominant? • Countries with growth in the chemical industry (e.g. Asia) • Europe has excess of batch infrastructure • Opportunity for developing countries where batch infrastructure not established • Disruptive technology….not here! • Substantial opportunities in Africa……

  3. Challenges in South Africa Availability of Chemicals • Often imported from Europe, India and China • Increases costs • Delays research within academia • Delays production in industry Can new technology enable cost-effective on-demand production? • Manufacture efficiently where needed……distributed production • Job creation and training (research capacity development) • New business opportunities • Strengthen economy • Improve health…..

  4. Medicines The mortality from major diseases, such as HIV/AIDS and TB, are much more devastating in Africa than in other regions of the world1 In 2012, life expectancy in sub-Saharan Africa was 55 years (78 in U.S.)2-4 Increased access to anti-retrovirals has lowered the incidence, however many patients are still under-treated5 Beyond the human suffering, there is also an economic impact of this disease6 Total cost of API imports to South Africa from just India R120billion ($10bn) over last 10 years CDC. HIV Surveillance Report, Vol. 23; February 2013. AnnualReviews.org, Annual Review of Public Health, 2013. UNDP Human Development Report 2013. http://www.healthdata.org/ Avert website: http://www.avert.org/impact-hiv-and-aids-sub-saharan-africa.htm Palitza K. Health-South Africa: HIV-Related Deaths Slows Economy, 2012: http://www.globalissues.org/news/2012/01/27/12553.

  5. Shortage of Medicines SA media report June 2015: Also concern about the quality of imported APIs Concern over guaranteed supply chains Lets manufacture quality products in Africa for Africa at lower cost

  6. AIDS/HIV: More Efficient Manufacture DoH initial benchmark targets: Total market size of R14 billion on 3 year tender for just anti-HIV APIs ……..and still a shortage! NMU patented processes towards: • Emtricitabine • Lamivudine developed • Efavirenz ChemistrySelect, 2017, 2, 1102-1105 • Org. Biomol. Chem., 2017, 15, 3444-3454. • Chemica Oggi, 2018, 36(5), 28-32.

  7. Drugs AIDS • Lamivudine • Emtricitabine • Efavarinz • Neveripine • Dolutegravir • Tenofovir • AZT TB and Malaria • Isoniazid • Lumfantrine • Tafenoquine Cancer • Sorafenib • Imatinib • Bortezomib • Sunitinab Diabetes • Glipizide • Gliclazide • Glimepiride • Glibenclamide Other • Tamiflu • Gatafloxacin • Trimethoprim • Valium

  8. Final thoughts…. Jean-Claude Juncker – State of the Union address 2018

  9. Conclusions Generic drug manufacture in Africa • AIDS • TB • Malaria…. Lower cost Guarantee supply chain Ultimately improve the health of society Can Africa do it alone: No International collaboration essential……but critical to train high quality scientists in Africa Develop strategic collaboration with other African countries Fund science in Africa not for Africa Positive is that students are keen to learn!

  10. Acknowledgements • Ms. Zizo Gqokoma • Ms. Sandiso Ngwenya • Mr. Muyiwa Arisekola • Mr. Martin Badenhorst • Ms. Sinazo Nqeketo • Mr. Harold Rupape • Mr. Karabo Bopape • Funding • Hull Researchers • Dr. Charlotte Wiles • Dr.BongkotNgamsom • Dr. Joe Dragavon • Dr. Vicki Hammond • Dr. Gareth Wild • Dr.TamsilaNayyar • Dr. Julian Hooper • Dr. Linda Woodcock • Dr.Haider Al-Lawati • Dr.NikzadNikbin • Dr. Ping He • Dr. Victoria Ryabova • Dr. Vinod George • Dr. Leanne Marle • Dr.Mairead Kelly • Dr. Ben Wahab • Dr. Mark Tarn • Dr. Francesco de Leonardis • Dr. Matthew Simmons • NMMU Researchers • Dr. Batsho Mpuhlu • Dr. Devender Mandala • Dr. Sunday Elaigwu • Dr. Lubabalo Mafu • Dr. Faith Akwi • Dr. Fidelis Chigondo • Dr. Sravanthi Chada • Dr. Kirstin Burger • Dr. Saira Mumtaz • Mr. Warren Thompson • Mrs. Ronelle Potgieter • Mr. Cloudius Sagandira • Mr. McQuillan Moyo • Ms. Bomikazi Madikizela • Mr. Themba Lubazana • Mr. Martin Strydom • Mr. Yakub Kadernani • Mr. Luphumlo Ncanywa • Mr. Matteo Fornero • Ms. Khanyi Mhlana • Mr. Francis Mathe • Mr. KK Mkwaki • Mrs. Thembela Sonti

  11. Acknowledgements

  12. Questions? +27 (0)41 5043694 Paul.Watts@mandela.ac.za

  13. www.mandela.ac.za

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