Pioneering a healthcare revolution with biosimilars and affordable therapies

In the fast-paced world of pharmaceutical innovation, a titan has risen. MiGenTra, a groundbreaking entity born from the merger of industry giants ProBioGen and Minapharm Pharmaceuticals, is rewriting the rules of healthcare as we know it. Established in the second quarter of 2021, this powerhouse is set to redefine the future through the development and commercialization of biosimilars, cell- and gene therapies (CGT), and vaccines.

At the helm of this revolutionary biosimilar company stands Dr. Lutz Hilbrich, the visionary Chief Executive Officer of MiGenTra, who proclaims with unwavering conviction, “MiGenTra offers a unique and compelling portfolio of 16 biosimilar drug candidates, along with affordably priced cell- and gene therapies. Our biosimilars portfolio is a beacon of hope for those battling a range of medical conditions, with a particular focus on oncology, autoimmune diseases, osteoporosis, ophthalmology, and respiratory ailments.”

MiGenTra’s strength is not confined to its ambition alone; it’s the fusion of ProBioGen and Minapharm’s unparalleled capabilities that sets it apart. Dr. Hilbrich paints the picture vividly, stating, “ProBioGen, with a storied history spanning 29 years in Berlin, is the leading Contract Development and Manufacturing Organization (CDMO) renowned for spearheading the development and manufacturing of biopharmaceutical active ingredients, viral vectors, and vaccines.”

“In contrast, Minapharm, a trailblazer established 65 years ago in Cairo, is a beacon of biotechnology in Africa, boasting a cutting-edge manufacturing facility for biological medicines. MiGenTra brilliantly marries the distinctive strengths and capabilities of its parent companies to deliver an unparalleled, all-encompassing offering to the market,” Dr. Hilbrich passionately explains.

A healthcare revolution in motion

MiGenTra’s mission extends far beyond profits and portfolios. Dr. Hilbrich passionately champions the efficient utilization of safe and high-quality medications at a reasonable cost. MiGenTra, under his guidance, plays a pivotal role in enhancing the affordability and accessibility of biologic drugs, with a particular emphasis on the Middle East and Africa.

Dr. Lutz Hilbrich reflects on the situation and states, “The Middle East and Africa region is an attractive market for biosimilars, driven by a confluence of factors such as the growing demand for cost-effective healthcare, high prevalence of chronic diseases, government initiatives, regional manufacturing capabilities, and unexplored prospects.

“Africa, which accounts for 16% of the world’s population, bears a disproportionate 23% of the global disease burden, primarily due to inadequate access to high-cost biological medicines, limited infrastructure, and insufficient awareness campaigns, especially in hard-to-access rural locations.”

Revolutionizing medicine with cutting-edge biosimilar manufacturing

Dr. Lutz Hilbrich unveils the secrets behind the company’s groundbreaking manufacturing process for biosimilars, poised to transform healthcare as we know it. Dr. Lutz Hilbrich kicks off the revelation by acknowledging the impending waves of change in the biopharmaceutical industry, emphasizing MiGenTra Egypt’s prowess in establishing two vital expression systems used in biotechnology. Notably, they harness the yeast expression system Hansenula polymorpha and the mammalian cell culture expression system Chinese hamster ovary (CHO) to develop processes for the production of new recombinant active pharmaceutical ingredients (API).

Explaining the significance, Dr. Lutz Hilbrich states, “To ensure safety and efficacy, each manufacturing facility complies with strict Good Manufacturing Practices (cGMP) regulations associated with quality testing related to the product. Each process and cycle must follow validated customer requirements to deliver stable, repeatable, and affordable products.”

Crucially, these biosimilar manufacturing facilities have received the seal of approval from the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), while adhering to the U.S. Department of Commerce’s Economic Development Administration (EDA) guidelines.

A symphony of quality assurance

Quality assurance takes center stage in MiGenTra’s biopharmaceutical manufacturing process, which Dr. Lutz Hilbrich elaborates upon. He delineates it into two critical phases: the cultivation process (upstream) and the purification process (downstream). Emphasizing their role, he remarks, “In order to guarantee the safety and effectiveness of our biosimilar products, we have established a comprehensive quality control system. This system involves rigorous testing of raw materials to verify their identity, purity, and quality.”

Dr. Lutz Hilbrich elucidates the company’s cost-saving prowess, a feat accomplished by leveraging ProBioGen’s highly productive cell lines, high-yield products of partner companies, and Minapharm’s efficient manufacturing capabilities. “By doing so,” he asserts, “the company can develop and commercialize quality biological medicines at a lower cost, passing on the benefits to patients and healthcare organizations, making the treatments more accessible and affordable.”

The manufacturing journey is marked by meticulous in-process testing, culminating in extensive physicochemical and potency assays, as well as stability testing. Dr. Lutz Hilbrich reveals, “Advanced analytical techniques, such as mass spectrometry and chromatography, are employed to evaluate the molecular structure and biological function similarity to the reference biologic.”

MiGenTra’s meteoric ascent

MiGenTra, a young but exceptionally ambitious entity, has ignited the industry with its meteoric rise. Born from the visionary merger of industry titans ProBioGen and Minapharm Pharmaceuticals just two short years ago, MiGenTra is already carving a unique path towards the future of healthcare.

Dr. Hilbrich offers a glimpse into this remarkable journey, stating with unwavering confidence, “While MiGenTra is a young company, it is on a high growth trajectory. In just two years since its inception, MiGenTra has managed to assemble an industry-wide unique portfolio of 16 biosimilar drug candidates. This achievement not only ensures business visibility but also solidifies our sustainability well into the early 2030s.”

At the heart of MiGenTra’s mission lies a groundbreaking endeavour to develop biosimilars for global blockbuster biological medicines that have transitioned beyond patent protection. This mission, as Dr. Hilbrich passionately emphasizes, is rooted in addressing unmet medical needs in Africa and beyond. He elucidates, “The company maintains a lean headquarters organization, functioning as a Centre of Excellence that houses seasoned experts in core functions for biological medicines. Our efficient development and manufacturing processes are made possible by harnessing highly productive cell lines from ProBioGen and leveraging state-of-the-art process development and manufacturing capabilities from Minapharm.”

In alignment with its audacious growth plan, MiGenTra is currently in the midst of constructing a robust network of distributors spanning Africa and the Middle East. This strategic initiative, Dr. Hilbrich explains, serves a dual purpose: “Our primary objective is to facilitate the registration, promotion, and sale of biological medicinal products in a manner that is both transparent and cost-effective. Simultaneously, we are unwaveringly committed to ensuring timely delivery, reinforcing our pledge to enhance access to critical healthcare solutions.”

Riding the waves of transformation

In a pharmaceutical landscape increasingly defined by change, Dr. Lutz Hilbrich reflects on the shifting tides, stating, “The biopharmaceutical industry has a major role in the development of cost-effective, robust, and reproducible processes to manufacture safe and efficacious products for various clinical indications.”

Unlike conventional pills with readily available generic counterparts, complex biologics produced using living cells cannot be exactly duplicated. Enter biosimilars, the most comparable alternatives. Dr. Lutz Hilbrich elaborates on MiGenTra’s manufacturing process for biosimilars, “Combining Minapharm’s known experience with biosimilars and ProBioGen’s expertise in cell- and gene-based therapeutic approaches and viral vector platforms for vaccine development, MiGenTra is ideally positioned to provide patients with affordable and quality care and to boost the MEA region’s drug manufacturing capabilities.”

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Seizing the African opportunity

As the biosimilar market charts a meteoric rise globally, MiGenTra is set to ignite a healthcare revolution in the African continent. Dr. Hilbrich begins by illuminating the global biosimilar market’s staggering growth potential, with a forecasted CAGR (compound annual growth rate) of 32 percent between 2020 and 2026. However, his focus is on a continent ripe for transformation, saying, “Africa’s growing population, the exorbitant prices for biologics, and unmet medical needs in the region are the perfect breeding ground for a flourishing biosimilar industry.”

In a profound revelation, Dr. Hilbrich unveils MiGenTra’s strategic approach, revealing, “At present, MiGenTra is not yet operational but is actively preparing to enter the African market by no later than 2024. The current focus is on meticulous preparation for the initial launches.”

For Dr. Hilbrich, the core mission is clear: “Striking a balance between affordability and maintaining high-quality standards is integral to the company’s mission of providing quality biological medicines at accessible costs for patients in Africa.” The secret sauce lies in a fusion of technology-driven solutions and strategic partnerships with ProBioGen, Minapharm, and other like-minded entities sharing their mission.

Highlighting the company’s positive reception, he states, “As a biosimilars manufacturing company in Africa, MiGenTra has been well-received, and our mission and concept have garnered positive feedback.”

Pioneering strategies

In a captivating revelation, Dr. Hilbrich takes us on a journey through the company’s pioneering strategies and global vision that are set to reshape healthcare as we know it. With the biosimilars landscape becoming increasingly competitive, Dr. Hilbrich delves into MiGenTra’s innovative strategies that are propelling them to the forefront. Dr. Hilbrich unveils MiGenTra’s winning formula, saying, “Our success hinges on two pillars – our in-house biosimilar development expertise and our partnership with Minapharm, a regional giant.”

What truly sets them apart is their vision to seize commercialization opportunities through strategic partnerships. Dr. Hilbrich underlines their progress, stating, “Currently, we have a foothold in 12 African markets thanks to Minapharm. But we’re not stopping there. We have bold plans to establish new export routes in priority countries, including Morocco, Algeria, Ghana, Nigeria, and Kenya. Our goal? To cover approximately 70% of the African population by 2028.”

A global vision of boundless reach

MiGenTra’s vision extends far beyond geographical borders, encompassing a commitment to making biosimilars affordable for patients in the Middle East and Africa. Dr. Lutz Hilbrich emphasizes their global readiness, stating, “We’re not just meeting biosimilar quality requirements in the US and the European Union; we’re also prepared to interact professionally with regulatory bodies worldwide, thanks to the EDA guidelines.”

As the biosimilars trend ripples through the global biologics industry, MiGenTra is strategically positioned to catalyse change in the Middle East and Africa. Dr. Hilbrich encapsulates their mission succinctly, “The demand for high-quality, affordable biologic medicines in the Middle East and Africa is substantial. Biosimilars, as cost-effective alternatives to expensive biologic drugs, are poised to address this demand, increasing accessibility to patients in need.”

“Considering the significant burden of chronic diseases such as cancer, diabetes, and autoimmune disorders in the MEA region, biosimilars offer comparable efficacy and safety profiles to reference biologic products,” Dr. Hilbrich concludes.

MiGenTra’s grit to revolutionize African healthcare

In the crucible of challenges, MiGenTra is emerging as resolute in its mission to provide affordable, high-quality biological medicines across Africa. Dr. Hilbrich unveils their strategy to navigate the complex landscape and seize the golden opportunity for change. With a spirit akin to diamonds formed under immense pressure, MiGenTra takes on the most intricate challenges as it intensifies efforts to bring high-quality, affordable biological medicines to patients across the African region. Regulatory complexities and the isolation of remote populations loom large as significant hurdles.

On the regulatory front, Dr. Hilbrich pinpoints a pivotal issue, stating, “One of the key challenges is the lack of harmonization in regulations across the 50+ countries in Africa concerning the review and approval process for biological medicines and biosimilars. This lack of uniformity can lead to delays in approvals and market access for our products.”

Undaunted, he outlines their proactive approach, noting, “To mitigate the regulatory hurdles, MiGenTra leaders intend to proactively engage with regulatory authorities in each African country, advocate for standardized review processes, and provide all necessary data and documentation to meet individual country requirements efficiently.”

Reaching the unreachable

Dr. Hilbrich acknowledges the population-focused challenges, revealing, “Approximately 60% of the African population lives in rural and isolated areas, with as much as 83% lacking access to essential healthcare services. Reaching patients in these remote regions presents logistical challenges.” In response, he shares a visionary plan, saying, “To overcome this, we will identify and collaborate with local partners who have extensive reach into the hard-to-reach areas.”

As MiGenTra strides into the future, Dr. Hilbrich emphasizes the significance of technology in bridging healthcare gaps in underserved regions. He states, “Going forward, we recognize the significance of leveraging technology to bridge the care gap in underserved regions. Investments in the development of telehealth solutions to support education, diagnosis, delivery, and monitoring of our products in remote areas is necessary to ensure that patients receive the care they need.”

He reaffirms their commitment, stating, “Establishing clear and efficient regulatory pathways for biosimilars is expected to nurture investment and development in the biosimilars market in Africa. At MiGenTra, we have managed regulatory hurdles by planning for product launches starting in 2024 and building a strong organizational structure to support multiple launches each year until at least the end of the decade.”

A €100 million turnover aspiration

In an audacious proclamation, Dr. Lutz Hilbrich, the Chief Executive Officer of MiGenTra, unveils their ambitious goal of reaching a €100 million (US$107 million) turnover. As the future unfolds, their strategic pillars—Africa, Science, Business, and Organization—hold the promise of transforming healthcare access and affordability across the African continent. With unwavering determination, Dr. Hilbrich sets the stage for a remarkable journey, stating, “We have set an ambitious goal of reaching a turnover of €100 million (US$ 107 million).”

The contours of their future strategies come into focus, a well-defined framework with four pivotal pillars. Dr. Hilbrich underscores their significance, declaring, “MiGenTra aims to make its products available in at least 10 countries across the continent. With science at the heart of all production processes, we aim to emerge as the premier developer of biopharmaceuticals in Africa and for Africa.”

For MiGenTra, an efficient organization is the cornerstone of success. Dr. Hilbrich reveals their commitment to meticulous structuring, optimization, and efficiency, stating, “To effectively execute its vision and mission, MiGenTra aims to build a fit-for-purpose organization. At MiGenTra, we are committed to contributing to the transformational change across healthcare on the African continent.”

Dr. Hilbrich’s vision is underpinned by a profound ideal, encapsulated in the words, “Healthcare is not a privilege but a human right!” With biosimilars at the forefront, MiGenTra holds the promise of significantly improving healthcare access, affordability, and health outcomes for the continent’s population.

Looking forward: Capitalizing on untapped opportunities

In a visionary stride that transcends borders, Dr. Hilbrich takes us on a journey into a future where healthcare transcends boundaries. With a resolute commitment to Africa’s biosimilars market, he unveils a roadmap poised to reshape healthcare access and outcomes on the continent. On the way forward, Dr. Hilbrich says: “To capitalize on the untapped opportunities in the biosimilars market in Africa.”

With a vision that embraces untapped potential, Dr. Hilbrich champions collaboration between industry stakeholders, governments, and regulatory authorities. He envisions a harmonious environment where intellectual property protection coexists seamlessly with affordable biosimilars, declaring, “By fostering an environment that balances intellectual property protection with increased access to affordable biosimilars, Africa can achieve significant advancements in healthcare and improve patient outcomes.”

Yet, he acknowledges the intricacies of the patent landscape, where multiple patents covering original biologic drugs pose a challenge for the biosimilars market in the region. Dr. Hilbrich reflects, “The dynamic nature of the patent landscape and data exclusivity continues to pose a challenge, particularly in relation to the biosimilars market in Africa.”

This feature appeared in the June 2022 issue of Healthcare Middle East & Africa. You can read this and the entire magazine HERE