1. Achieving Sustainable API Production in Africa
Perrer N. Tosso, Ph.D.
Global Innovation Manager
Medicines for All Institute
June 3, 2019
Africa Pharma Conference
Johannesburg, South Africa

2. Medicines for All: Our Mission
Improve Access to Critical Medicines
(i.e., treatments for HIV, malaria, tuberculosis)
Introduce new, easily transitioned routes to critical medicines
Train the next generation of process oriented innovators
Develop new methods, technology and approaches

3. Current State of Drug Manufacturing in the World

4. Drug Manufacturing in Africa & Its Constraints
Improved access to affordable medicines
Improved quality-assurance of medicines
Cater to local health needs (e.g. increased production of TB, malaria, & NTD drugs)
Sustainability of local production
API: 75% cost of the finished pharmaceutical product
Primary
Manufacturing
Production of APIs, Intermediates and Excipients
Secondary
Manufacturing
Formulation
Tertiary Manufacturing
Packaging of pre-formulated products.
Small scale production
Three in Sub-Africa
Most Common in Africa

5. Drug Manufacturing in Africa & Its Constraints
Proposed Solutions
Reinforced quality control capability
Strengthen and harmonized regulatory system
Targeted training of the workforce
Increased production of APIs
Adoption of continuous manufacturing
Improved access to affordable medicines
Improved quality-assurance of medicines
Cater to local health needs (e.g. increased production of TB, malaria, & NTD drugs)
Sustainability of local production
Primary
Manufacturing
Production of APIs, Intermediates and Excipients
Secondary
Manufacturing
Formulation
Tertiary Manufacturing
Packaging of pre-formulated products.
Small scale production
Constraints
Small local markets
Shortage of skilled human capital
Lack of skilled entrepreneurs
Long lead times
Immature regulatory system

6. Drug Manufacturing in Africa & Its Constraints
Proposed Solutions
Reinforced quality control capability
Strengthen and harmonized regulatory system
Targeted training of the workforce
Increased production of APIs
Offering cost reduction (to be competitive)
Implementing green chemistry principles
Adoption of continuous manufacturing
Improved access to affordable medicines
Improved quality-assurance of medicines
Cater to local health needs (e.g. increased production of TB, malaria, & NTD drugs)
Sustainability of local production
Primary
Manufacturing
Production of APIs, Intermediates and Excipients
Secondary
Manufacturing
Formulation
Tertiary Manufacturing
Packaging of pre-formulated products.
Small scale production
Constraints
Small local markets
Lack of skilled entrepreneurs
Shortage of skilled human capital
Long lead times
Immature regulatory system

7. Medicines for All Model
An Approach Toward Competitive & Sustainable Production of APIs $
Process Cost of Goods
Process Mass Intensity
mass of reactants
S starting material costs * S Yield
PMI =
mass of products

8. Current route uses the following registered starting materials.
Nevirapine Example
Nevirapine:
Anti-HIV
NNRT Inhibitor
Innovator: BI
Current route uses the following registered starting materials.
The process has many unit operations, high PMI and costly starting materials: +
2-CAN
CAPIC
2nd Generation Nevirapine Process
M4ALL Nevirapine Process

9. Nevirapine Example
PMI from 46 to 11

10. THANK YOU