In an exclusive interview, Prem Mandalapu, General Manager, Commercial, ASEAN at Cytiva, sheds light on Cytiva's BioChallenge and its objective of supporting biotech startups in Southeast Asia. The BioChallenge aims to address the challenges faced by these startups, such as talent acquisition and scalability, while fostering collaboration between government, academia, and the industry. With success stories from previous winners like VivaZome and Genexine, BioChallenge has proven instrumental in accelerating the development and growth of biotech startups in the Asia Pacific region. Prem also discusses the selection criteria used, the role of esteemed judges, and the potential expansion of BioChallenge to other countries or regions. Additionally, Dr. Natasha Ng, Co-Founder of BetaLife, shares insights into their winning company and their plans to utilize the awarded FastTrak services to advance their research in novel induced pluripotent stem cell (iPSC) therapies for diabetes patients.

Can you provide an overview of Cytiva's BioChallenge and its objective in supporting biotech startups in Southeast Asia? 

Prem: The biotech industry is at the forefront of accelerating the development of novel therapies that have the potential to transform human health. However, small to medium-sized biotechs in Southeast Asia still face talent, resource, and scalability challenges in their journey to bring their innovations to market. We know that nobody can do it alone. Collaboration between government, academia, and the industry is needed if we want to collectively strengthen the biotech ecosystem here.

By bringing BioChallenge, for the first time to Southeast Asia, we do our part to help promising biotechs bring highly advanced innovations from discovery to delivery. In APAC, we’ve seen good success, for example, with winners VivaZome in Australia and New Zealand as well as Genexine in South Korea which has gone on to become the face of K-bio.

Globally, since 2018, the impact of our BioChallenge competition has been very fruitful. We supported 130 projects through flexible access to bioprocess development, technology verification, and opportunities to collaborate alongside industry experts and institutional investors. This is very meaningful for us.

What were the selection criteria used by the panel of judges to choose the winners of the Southeast Asia BioChallenge?

Prem: Every BioChallenge proposal was assessed based on five criteria which include project rationale, experimental outline, expertise, how companies want to be supported, and future business impact. Out of all applications, the five finalists, including the three winners, were invited to pitch to the judges based on their strong potential to advance the delivery of therapeutics that can benefit patients in the region.

All entries were assessed by Southeast Asia BioChallenge's panel of judges, which included a mix of leading international and regional industry leaders. From the region, we were honoured to have Dr Koh Boon Tong, Executive Director, A*STAR Bioprocessing Technology Institute (BTI) from Singapore and Dr Chairat Uthaipibull, Deputy Chief Executive Officer, Thailand Center of Excellence for Life Sciences (TCELs) from Thailand. From Cytiva, we had Dr Daria Donati, Chief Scientific Officer, Genomic Medicines who is based in Sweden and Dr Iwan Roberts, Senior Director of Open Innovation, who is based in the UK.

Could you share some details about the winning company, BetaLife, and their novel induced pluripotent stem cell (iPSC) therapies for diabetes patients? How do they plan to utilize the awarded FastTrak services to advance their research?

Natasha: BetaLife is developing human induced pluripotent stem cell (hiPSC)-derived pancreatic islet cells as a cell replacement therapy for patients with severe diabetes. These cells will benefit both Type 1 and Type 2 diabetes patients who must take lifelong insulin injections to control their blood glucose levels and reduce the progression into diabetic complications. The islet cells are derived from our unique stem cell source using a proprietary protocol to provide an on-demand, regenerative medicine product. We hope to utilize Cytiva’s FastTrak services to optimize the scale-up process of our hiPSC-derived islet cells, from a research scale to a manufacturing scale suitable for large-scale research work as well as early-phase clinical trials. The optimization process will also focus on ensuring high levels of consistency and robustness within each production batch while maintaining quality and cost efficiency. The cells generated will go towards helping us to achieve our proof-of-concept milestones.

What advantages does winning the BioChallenge offer to the participating startups in terms of scaling up manufacturing, process development, and accelerating the translation of regenerative medicines?

Natasha: BioChallenge will enable us to access Cytiva’s expertise across different cell and gene therapy requirements, such as in scale-up processes for cell manufacturing involving bioreactor platforms, cell culture media solutions and cryopreservation technologies. Early-stage biotech startups like BetaLife have limited resources and funding, therefore support from an established company with a track record in supporting the CGT sector will facilitate our transition from research scale to tackling challenges in robust cell manufacturing upfront. The collaboration will go hand-in-hand with BetaLife’s domain-specific expertise in islet cell biology and diabetes and help us to remain highly competitive and keep up with fast-paced developments in CGT.

How does Cytiva's BioChallenge address the challenges faced by biotech startups in Southeast Asia, such as finding collaborators for R&D and sourcing necessary talent?

Natasha: It is an incredible opportunity offered by Cytiva to provide dedicated support to companies in Southeast Asia. Compared to other parts of the world such as Europe and the USA which have more mature biotech ecosystems, access to collaborations, technical talent and regulatory expertise particularly in the CGT space is sparse. This is even more pertinent for iPSC-based therapies which represent the new and upcoming frontier for regenerative medicine. The Cytiva BioChallenge enables us to develop solutions for cell manufacturing early which is often overlooked in a biotech start-up’s development.

What role do regional industry leaders, such as Dr Koh Boon Tong and Dr Chairat Uthaipibull, play in the BioChallenge as judges? How does their expertise contribute to the selection process? 

Prem: With over 30 years of experience in the private sector, Dr Koh Boon Tong came onboard as a judge with deep expertise in managing projects by startups, plant operations, technical applications, and development labs. His extensive experience on numerous boards, including joint ventures, is valuable when assessing the business impact, the applicants can make in the region.

Dr Uthaipibull, on the other hand, is the Deputy Chief Executive Officer at Thailand Center of Excellence for Life Sciences (TCELs), a crucial ecosystem builder in Thailand’s biotech industry. His deep expertise in areas such as accelerating innovations, building a conducive ecosystem and catalyzing and connecting partners in Thailand, as well as his experience as the recipient of “Excellent” Research Award from the National Research Council of Thailand in 2016-2017, provides another unique and valuable perspective on what the Thai market needs.

Can you elaborate on the therapeutic areas of interest for the companies that applied to the Southeast Asia BioChallenge? Are there any specific areas that showed notable advancements or potential? 

Prem: All Southeast Asia BioChallenge applications were diverse. From plant-produced recombinant proteins to regenerative medicines for diabetes, they all focused on four specific therapeutic areas - novel vector and/or payload design, novel therapeutics, novel vaccines, and antibody-based molecules.

The applications from our winners, Singapore-based company BetaLife, Tessa Therapeutics, and Thailand-based BGF Plantrix, were chosen for their strong potential to advance the delivery of therapeutics that can benefit patients in the region.

Are there any plans to expand the BioChallenge to other countries or regions in the future?

Prem: We are continuously looking to drive growth and evaluating all potential opportunities to bring BioChallenge to other countries and regions in future.

How has the BioChallenge contributed to the growth and development of biotech startups in the Asia Pacific region, as evidenced by the success stories of previous winners like VivaZome and Genexine? 

Prem: I’m proud to share a couple of examples of how we play our part to build the ecosystem to nurture biotech startups through collaboration with the government and investors. In South Korea, BioChallenge engaged the Korean Ministry of Health and Welfare and the Ministry of Food and Drug Safety to join as co-sponsors. Two participants of the first season of BioChallenge, GI Innovation and Yuhan Corporation, have since gone on to sign a million USD deal to jointly develop and commercialize a treatment of allergic diseases. Another BioChallenge winner, Genexine, has risen to become the face of K-bio.

In the first ANZ BioChallenge in 2022, VivaZome Therapeutics, an emerging exosome-derived therapies developer, was awarded the top prize valued at approximately AUD $200,000. Since then, Vivazome has entered a Memorandum of Understanding (MoU) with The University of Queensland (UQ) focusing on improved therapies for Traumatic Brain Injury (TBI) and post-traumatic epileptogenesis (PTE) and this year, has been awarded an Australian Government Round 13 CRC-P grant of $3 million in support of the 3-year project on customised exosomes – the future of regenerative medicine. 

In what ways does Cytiva collaborate with the winners and participants beyond the BioChallenge to further support their innovation and success in the biotech industry? 

Prem: As mentioned earlier, we help bridge high-potential biotechs with the government, incubators and our own industry experts to help them bring their innovations from molecule to market. 

Beyond that, in China, for example, BioChallenge goes a step further to bridge startups with investors. In 2022, we attracted over 110 submissions and thousands of investors. As a result, the winner, GENHOUSE, received $14 million in funding to develop a small molecule anti-tumor drug. 

Natasha: Beyond BioChallenge, continued interactions with Cytiva will be very beneficial to ensure continuity and that BetaLife is able to fully utilize the processes and protocols developed during the project. The new technologies and know-how acquired during the project will also be a key component of BetaLife’s intellectual property. The relationship with Cytiva can be further extended through the continued use of its services, deployment of equipment and media solutions, GMP-compliant workflows or other automation or digitization software. These remain as critical steps for bringing our hiPSC-derived islet cell products closer to clinical development.