Tech transfer in the pharma industry: The need of the hour for African biopharma self-sufficiency


In the late 1990s and the early 2000s, Eli Lilly did something which wasn’t very common. The Big Pharma company transferred technology for two tuberculosis (TB) drugs to pharma manufacturers in South Africa. This early instance of tech transfer in the pharma industry in Africa effectively helped fight the multi-drug resistant TB problem.


More recently, BioNTech – a developer of one of the most widely used Covid-19 vaccines globally – executed a project in Kigali, Rwanda. Modular elements were assembled at the project site to allow the African country to produce the Covid vaccine domestically. Inaugurated in December 2023, this plant is expected to initially produce 50 million vaccine doses, with production set to increase based on demand for mRNA-based vaccine candidates for malaria and TB. This vaccine manufacturing project is potentially one among a wider supply network across many African countries.


The tech-sharing element of this partnership has shown that it is possible to democratise access to vaccine technology. It has shown that better health outcomes don’t have to be a pipe dream for a large part of the African population. Still, a lack of technology licenses and technology sharing stands in Africa’s path towards biopharmaceutical self-sufficiency.


What is coming in the way of more widespread technology transfer in the pharmaceutical industry in Africa?


What is tech transfer?

According to the United States Food and Drug Administration (US FDA), technology transfer is “the process of transferring skills, knowledge, technologies, and manufacturing methods” from a source, such as governments, universities, and other institutions, to users, like pharmaceutical companies or contract development and manufacturing organisations (CDMOs). Receivers may develop and use the scientific and technological developments received to manufacture new products, processes, materials, or services.


It goes without saying that such tech transfers in the pharma industry occur under formal mechanisms. For example, the US FDA’s Technology Transfer Programme uses Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), and Confidential Disclosure Agreements (CDAs) as frameworks to guide tech sharing.


Technology sharing or transfers are not a one-step process between biopharma developers or research institutions and pharma manufacturers. Biopharmaceutical lifecycle management encompasses every stage of drug development, from drug candidate identification and clinical trials for efficacy to manufacturing processes and the logistics of getting therapies to patients. Each of these aspects of getting therapies to patients is usually a separate activity with its own set of tools and expertise. Tech transfer bridges the gaps between each of these sequential steps in the biopharma lifecycle.


Technology transfers are an integral part of the global pharmaceutical industry. With more and more complex therapeutics being developed nowadays, the importance of effective and efficient tech transfer between biopharma developers and manufacturers cannot be overstated. Thankfully, there are internationally accepted frameworks and roadmaps to guide the process, especially in developing countries that need tech transfers the most. For instance, the World Health Organisation (WHO) has the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property – designed to support investment in local pharma industries, promote tech transfer, and develop health system resilience through on-site medicine manufacturing in developing countries.


Africa’s need for tech transfer

Building pharmaceutical manufacturing capabilities in Africa requires a holistic approach, integrating financing mechanisms, regulatory systems, skills development, and, most importantly, technological know-how.


The pharma manufacturing ecosystem in Africa has known this for a while. For years, the African Regulatory Network (ARN) has called for technology transfer to enhance pharmaceutical access and act as a point of entry for pharma companies on the continent. With an operationalisation agreement inked in December 2023, the African Pharmaceutical Technology Foundation (AFTP) has also dedicated itself to supporting indigenous African pharma by building human, institutional, and technological capabilities.


The CEO of the APTF recognises that access to knowledge, skills, tech, and manufacturing methods for pharma products is essential – it ensures that financial investments in African pharma are sustainable. In interviews, she has made a clear case for focusing on technology sharing and knowledge sharing to build and diversify capacity in the pharma value chain.


Ostensibly, technology is the central transformative tool to help Africa not only achieve biopharmaceutical self-sufficiency but also develop a globally competitive pharma industry.


Complexities in pharmaceutical tech transfer

Technology licenses and tech transfers are indescribably important in the pharma industry. But with such significance comes a high level of complexity. Since they haven’t received adequate attention, these complexities exist in fairly developed pharma industries. Naturally, they also exist in more fledgling pharma industries.


Diversity of functions

As we’ve mentioned, the biopharmaceutical lifecycle is long and complex. This means that technology transfer in biopharma is, too. Tech transfer is more than just providing a toolbox or building a manufacturing facility. It depends on a multitude of factors in source and host countries, including financial assistance, tax deductions, appropriate capital markets, intellectual property rights protections, a skilled workforce, and a viable local market.


Experts indicate that tech transfer occurs in 8 main steps each, at the source and host sites. Each of these steps, meanwhile, encompasses 20 to 30 distinct activities. This large number of functions – spanning the donor site, the receiving site, and, on occasion, also a headquarters – quickly adds up. With process adaptations and equipment modifications, the complexity of the entire operation can be overwhelming.


Lengthy timelines

Pharmaceutical manufacturing capacity should ideally be developed as quickly as possible. This is especially the goal in low- and middle-income countries (LMICs) in regions like Africa that are already playing catch up. However, tech transfer can be an extremely lengthy process. It can take 18 to 30+ months for sterile dosage forms like injectable vaccines. For other products, a 27 to 29-month timeline is standard. This process takes even longer – 5.8 months longer on average – when transfers are made to an external party. Pharma developers often begin transferring technologies before they have conclusive clinical data just to avoid the economic costs of such lengthy delays.


Clarity in communication

When there are so many elements to share as part of technology licenses or tech sharing or transfer agreements, downstream recipients are sometimes bound to feel like it’s a game of Chinese whispers. Manufacturers have noted that they have sometimes received complicated tech transfer requirements with unclear instructions. Such lack of clarity can compromise the process, the product, and even the partnership.


PodTech™️’s solution to these complexities

With its prefabricated solutions for biopharma manufacturing, PodTech™️ also offers optional technology licenses and tech-sharing options. These encompass fill-and-finish, inhalation suites, onco, and novel products. With established manufacturers from around the world as sources, governments and businesses using these tech licenses can be certain that they are receiving the very best quality in the industry.


PodTech™️’s podule™️ concept is approved by the US FDA, the UK MHRA, and EU GMP – so recipients don’t have to worry about regulatory acceptance. Each of the podules™️ is validated before shipping – so you can be assured of regularity. PodTech™️’s podules™️ are all pre-fabricated and self-contained, equipped with systems for air handling, building management, fire protection, electrical, and process utility – so you don’t have to be concerned with lengthy lead times and complex functions before you kick off production.


As Big Pharma companies remain overly protective of their technological know-how, there are still challenges to making knowledge and skills freely available to those who need them most. However, with initiatives like the mRNA technology transfer hub in South Africa, things are looking up for biopharma manufacturing capabilities in LMICs around the world, despite the challenges. With its technology licenses supporting capacity development, PodTech™️ is an important part of the puzzle.


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