Bio-Biopharmaceutical Manufacturing Services for the African Continent

In partnership with industry and academia from USA, EU, India, China, and Africa

A. Importance of Manufacturing Health Products in Africa

The COVID-19 pandemic exposed Africa’s vulnerabilities in ensuring access to vital medicines, vaccines, and health technologies. In most nations of sub-Saharan Africa, imports comprise as much as 70 to 90 percent of the pharmaceuticals consumed. For vaccines, imports account for over 99 percent.

Given the current situation, The African Union’s New Public Health Order aims to safeguard the health and economic security of the continent, and the first pillar of this order is to expand the manufacturing of vaccines, diagnostics and therapeutics.

To achieve this objective, African nations are prioritizing building infrastructure and systems for local production, including the engineering, financing, regulatory, trade, technology, and human resources needed to build an industry. In turn, African pharmaceutical industries are responding to this new demand with ambitious projects.

In response to the African Union’s vision, and to support the African pharmaceutical sector, Empower’s Manufacturing Center is partnering with government, industry, academia and the United Nations to accelerate this vision. Empower has partnered with world-class organizations in the US, Europe, India, China and Africa to accelerate African pharmaceutical industry growth.

B. Overview of Empower and Our Services

Empower Group has been working with governments and industries in over 40 countries for more than a decade. Our new Centre for Pharmaceutical Manufacturing and Capacity Building focuses on transforming Africa into a manufacturing hub for high-quality pharmaceuticals and medical products.

Empower has expanded its team and developed new partnerships, bringing a wealth of experience in manufacturing projects across Africa, Middle East and Asia that includes establishing new facilities, upgrading existing plants and introducing new products that have been approved by the US FDA, EMA, and WHO-GMP.

The new Centre offers services ranging from full life-cycle project support, including concept development, feasibility assessments, master planning, architectural design, detailed engineering, risk & hazard management, construction management, validation and commercial startup.

The new Centre also offers detailed engineering support which includes facility design, focusing on HVAC systems, building management systems (BMS), and the treatment, purification, filtration, and distribution of utility systems. We have experience in developing detailed piping and instrumentation diagrams for process and utility systems, alongside alternative plant layouts meeting regulatory requirements. We also provide men/material flow drawings and civil/structural engineering solutions. Additionally, our process engineering expertise ensures optimal equipment selection.

C. Centre for Pharmaceutical Manufacturing and Capacity Building Services

Refer to the detailed section on ‘Investing in human capital in Africa.’

D. Investing in Human Capital in Africa

Educating and skilling the manufacturing workforce in pharmaceuticals, vaccines, devices and diagnostics

A critical requirement for expanding local production is to have a large pool of qualified and talented human resources. To do this, the manufacturing sector needs to work with many kinds of organizations from all over the world, including a) with universities to expand the pool of graduates b) with technical institutes for skilling and mentoring c) with industry for internships and on-the-job coaching, and d) with digital learning organizations for improving knowledge.

Digital learning can help fill part of the gap: flexible self-paced e-learning, supplemented with digital simulated training, can deliver cost-effective, standardized and customized training to a large number of people. Reviews of e-learning studies found that computer- and web-based e-learning methods are as effective for building knowledge and skills as traditional learning methods.

The five key areas for skilling and knowledge management that are needed in the workforce include: R&D, Regulatory and Quality Assurance, Operations and Engineering Management, Business Management and Support Functions.

• R&D: laboratory operations, clinical trial design, new product development, GMP, and scale-up
• Regulatory and QA: regulatory compliance, product registration, GMP, GXP audit preparations, post-market surveillance, pharmacovigilance, GLP, and process validation
• Operations & Engineering Management: supply planning, sourcing (raw materials, excipients, machinery, lab reagents), procurement, production, GMP, equipment and floor operations, safety and environmental management and continuous improvement
• Business Management: Leadership and management (project management, performance management, portfolio management, market analysis), sales & marketing and risk management
• Support Functions:Human resources, IT/MIS, finance, legal and communication

Empower School of Health – Your Manufacturing Solutions Partner

E. Our Team

• Professor Paul Lalvani: Founder and Executive Director, Empower School of Health
• HE Michele Sidibe: AU Envoy to the African Medicines Agency, Senior Advisor and Visionary, Empower School of Health
• Kaushik Desai: Pharmaceutical Manufacturing Expert, Senior Advisor, Empower School of Health
• Abdelkrim Smine, PhD: Former Director of Global Public Health, Africa, US Pharmacopeia (USP), Senior Advisor and Faculty, Empower School of Health
• Bruce Lerner: Strategy Management Consultant, Public Health, Senior Advisor, Empower School of Health
• Sakhile Dube-Mwedzi: Programme Coordinator, SADC Medical Products Regulatory Harmonization Programme, Senior Advisor and Faculty, Empower School of Health
• Dr. T S Rao, PhD: Former-Department of Biotechnology, Govt. of India, Senior Advisor, Empower School of Health
• Dr. Ray Yip: Former Head of Gates Foundation in China, Experience in strengthening Africa CDC and building Pharmaceutical Manufacturing Capacity in Africa

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