Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Published on 15 April 2025
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Abstract: |
Submitted: 6 March 2025; Revised: 7 April 2025; Accepted: 10 April 2025; Published online first: 15 April 2025
Introduction
Yerlika Biopharma, founded in 2016, is a pioneering biotechnology company dedicated to localizing biopharmaceutical production in Turkey while expanding its presence in global markets. In an interview with GaBI (Generics and Biosimilars Initiative), Yerlika’s CEO, Hasan Zeytin, MD, PhD, shared insights into the company’s mission and strategic approach.
With a strong emphasis on innovation, high-quality manufacturing, and strategic partnerships, Yerlika is actively shaping the future of the biopharmaceutical industry. The company provides state-of-the-art CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) services, leveraging its advanced manufacturing facility located in the Çerkezköy Organized Industrial Zone. Equipped with cutting-edge bioprocessing technologies, GMP (good manufacturing practices)-compliant production systems, and a highly skilled workforce, Yerlika delivers world-class biopharmaceutical solutions. The company specializes in the development, optimization, and large-scale production of biologicals, including follow-on biologicals (FOBs)/biosimilars, monoclonal antibodies, gene therapies, vaccines, and other complex biopharmaceutical products.
At its core, Yerlika’s mission is to reduce Turkey’s reliance on imported biologicals, strengthen local production capabilities, and position the country as a globally competitive biotechnology hub. Through continuous investment in research, infrastructure, and regulatory excellence, Yerlika is playing a pivotal role in advancing Turkey’s biopharmaceutical sector while ensuring greater accessibility to innovative, life-saving treatments for patients worldwide.
By upholding a commitment to scientific excellence, operational flexibility, and fostering long-term collaborations with international partners and governmental institutions, Yerlika is not only manufacturing biologicals but also driving Turkey’s transformation into a leading centre of biotechnology and pharmaceutical innovation.
Localization of biotechnological products and bioprocess innovation
Yerlika is committed to strengthening Turkey’s biopharmaceutical industry by developing and localizing biotechnological products that meet international standards. Through cutting-edge research, advanced manufacturing technologies, and strategic collaborations, Yerlika is actively reducing the country’s reliance on imported biopharmaceuticals. The company focuses on several key innovation areas.
Follow-on biologicals (FOBs)/biosimilars
Yerlika is a pioneer in FOB/biosimilar drug development, emphasizing domestic production to provide affordable, high-quality alternatives to imported biologicals. By enhancing FOB/biosimilar manufacturing capabilities, the company improves patient access to life-saving treatments while reducing the financial burden on the healthcare system. Yerlika’s expertise in process development and scalability ensures that FOBs/biosimilars meet global regulatory standards while maintaining high therapeutic efficacy and safety.
Monoclonal antibodies
Yerlika is advancing monoclonal antibody (mAb) technology, delivering highly specific, targeted therapies for oncology and autoimmune diseases. These next-generation biologicals are designed to enhance treatment precision, minimize side effects, and improve patient outcomes. The company’s proficiency in mammalian cell culture systems, purification processes, and analytical characterization enables the efficient production of mAbs for diverse therapeutic applications. By supporting its partners in development and manufacturing, Yerlika plays a pivotal role in expanding access to innovative antibody-based treatments.
Gene therapies and viral vectors development
Yerlika provides CDMO services for viral vector-based gene therapy production, leveraging its expertise in mammalian cell-based biopharmaceuticals. The company supports clients in developing adenovirus-associated viral vector therapies for melanoma treatment, providing tailored manufacturing solutions, process optimization, and scale-up capabilities. This expertise enables Yerlika’s partners to efficiently develop and commercialize advanced immunotherapy solutions that enhance the body’s natural ability to combat melanoma cells. With its robust capabilities in mammalian cell-based biopharmaceutical production, Yerlika ensures flexibility, efficiency, and regulatory compliance in the production of next-generation therapies.
Vaccine development
In response to global health challenges, Yerlika is spearheading innovative vaccine projects for viral and bacterial diseases. The company’s expertise in recombinant vaccine platforms and adjuvant technologies ensures the development of effective and scalable immunization solutions. Notably, Yerlika has contributed to COVID-19 vaccine development and manufacturing, including supporting Sputnik V-related projects and playing a key role in the production and development of a locally developed vaccine in Turkey. These efforts underscore Yerlika ’s commitment to pandemic response initiatives and its ability to adapt manufacturing capabilities to urgent global healthcare needs.
Formulation and lyophilization
Yerlika provides customized formulation and lyophilization solutions to enhance the stability, efficacy, and shelf life of biopharmaceutical products. The company’s advanced lyophilization (freeze-drying) technology ensures that products retain high bioavailability and therapeutic performance while improving ease of storage and transportation. Yerlika collaborates with global partners, including a Canadian dermocosmetic company, offering tailored formulation solutions for specialized dermocosmetic products. With a strong focus on process optimization and quality assurance, Yerlika’s GMP-compliant facilities provide the infrastructure for scalable and flexible biopharmaceutical production. These capabilities position Yerlika as a preferred partner for international companies seeking reliable CDMO services in formulation and lyophilization.
Technological superiority, technical expertise, and production flexibility
Yerlika continuously enhances its technical capabilities and manufacturing infrastructure to ensure efficiency, scalability, and compliance with global pharmaceutical standards. By integrating cutting-edge technologies, the company optimizes production processes and maintains high-quality biopharmaceutical manufacturing.
Advanced infrastructure and GMP-compliant operations
Yerlika’s state-of-the-art production facilities include advanced bioprocess development and quality control (QC) units, enabling efficient process optimization, analytical testing, and regulatory compliance. These capabilities ensure the production of high-quality, stable, and effective biopharmaceuticals. Operates under strict GMP guidelines, the company guarantees full regulatory compliance and adherence to global quality standards. Its robust quality management system ensures consistent product reliability and safety, solidifying its reputation as a trusted CDMO partner.
Single-use bioreactors for enhanced flexibility
To enhance production flexibility and efficiency, Yerlika employes single-use bioreactors with capacities of 10 L, 50 L, and 500 L. These advanced systems enable faster turnaround times, minimize cross-contamination risks, and offer greater adaptability for diverse production scales.
Comprehensive R&D and innovation capabilities
With a dedicated R&D team, Yerlika focuses on next-generation biopharmaceuticals, driving process efficiency and exploring new therapeutic opportunities. The company collaborates with global research institutions and industry partners to drive bioprocess innovation and advanced drug development.
End-to-end biopharmaceutical solutions
From early-stage development to commercial-scale production, Yerlika delivers comprehensive biomanufacturing solutions that tailored to biologicals, FOBs/biosimilars, gene therapies, monoclonal antibodies, and vaccines. This end-to-end approach positions the company as a reliable partner in the biopharmaceutical industry.
Quality and regulatory compliance
Yerlika is committed to maintaining the highest standards of quality assurance and regulatory compliance, ensuring that all products meet stringent national and international safety and efficacy requirements. The company implements a comprehensive quality management system, where every stage of production—from raw material procurement to final product release—undergoes rigorous quality control and validation procedures to guarantee consistency and safety.
Operating in full compliance with GMP, ISO certifications, and international regulatory guidelines, Yerlika aligns its manufacturing standards with European and global pharmaceutical regulations. This commitment is further reinforced through regular audits, process enhancements, and compliance training, ensuring continuous improvement and adherence to the latest industry advancements. By integrating these practices, Yerlika consistently delivers products of exceptional quality while upholding its dedication to regulatory excellence.
Follow-on biological (FOB) products under development
Yerlika is actively involved in the development and manufacturing of FOB/biosimilar products across various therapeutic areas. Table 1 presents a list of FOBs/biosimilars currently under development, submitted for regulatory approval, or planned for submission to Turkey’s medicines regulatory agency—TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu, the Turkish Medicines and Medical Devices Agency)—for market authorization in Turkey.
| Table 1: Yerlika’s follow-on biological/biosimilars under development or marketed in Turkey | |||||
| Active Ingredient | Main Indication | Form | Development and Manufacturing Status | Regulatory Approval Status1 | Expected MA Date |
| Eptacog Alfa | Haemophilia | Vial | For local manufacturing, technology transfer ongoing | Approved in Turkey in 2021 | Marketed since 2022 |
| YBioA4002 | Solid Cancer | Vial | 3 validation batches manufactured (API and F&F) | Application to be submitted by Q2/2025 | 2026 |
| YBioF0002 | Breast Cancer | Vial | 3 validation batches manufactured (F&F) | Application to be submitted by Q4/2025 | 2026 |
| Teriparatide | Osteoporosis | Pen | 3 validation batches manufactured (F&F) | Application to be submitted by Q2/2025 | 2026 |
| Follitropin Alfa | Infertility | Pen/Vial | 3 validation batches manufactured (API and F&F) | Application to be submitted by Q1/2027 | 2028 |
| Efmoroctocog Alfa | Rare Blood Diseases | Vial | Cell line and process development (API and F&F) | Application to be submitted by 2028 | 2029 |
| 1All medicine regulatory applications are submitted to Turkey’s TİTCK – Turkish Medicines and Medical Devices Agency.API: active pharmaceutical ingredient; F&F: formulation and filling; MA: marketing authorisation; PFS: pre-filled syringe. | |||||
These FOB/biosimilar projects underscore Yerlika’s dedication to creating high-quality, accessible biopharmaceutical treatments that address both local healthcare demands and global market growth.
Client-centric partnerships and collaboration
Prioritizing long-term strategic partnerships and a customer-centric approach, Yerlika works closely with its global partners to drive innovation, efficiency, and regulatory compliance in biopharmaceutical development and manufacturing. The company collaborates with leading pharmaceutical companies, biotech firms, and research institutions to develop and manufacture high-quality biologicals, FOBs/biosimilars, and advanced therapies, leveraging its expertise in bioprocess development, formulation, manufacturing scale-up, and regulatory compliance. Offering tailored CDMO services, Yerlika provides customized solutions to meet the unique needs of its partners. Additionally, the company supports clients with regulatory filings, quality control, and global market entry strategies, ensuring seamless product commercialization. With a commitment to excellence, Yerlika maintains GMP-certified facilities and world-class infrastructure, delivering high standards in contract manufacturing and product quality. This dedication positions Yerlika as a trusted global CDMO partner, dedicated to advancing the biopharmaceutical industry.
A brief overview of the partnership projects:
Targeted biotechnological treatments for rare diseases: The company collaborates with its partners to develop precision biopharmaceutical therapies for rare diseases, delivering innovative and effective solutions to address unmet medical needs.
Adenovirus-based cancer vaccines and immunotherapy solutions: Yerlika offers comprehensive CDMO services for the development and manufacturing of adenovirus-based cancer vaccines and immunotherapy solutions. By supporting its clients in bringing next-generation cancer treatments to market, Yerlika plays a pivotal role in advancing global patient care.
TÜBİTAK-supported biosimilar development and government collaborations: Yerlika actively partners with leading governmental institutions and TÜBİTAK to drive progress in FOB/biosimilar medicines development. The company is currently engaged in two major FOB/biosimilar localization projects in collaboration with TÜBİTAK, underscoring its dedication to strengthening Turkey’s biotechnology sector. Additionally, Yerlika maintains ongoing dialogue with the government to explore opportunities for developing new molecular entities, ensuring alignment with national healthcare priorities and fostering innovation in the field.
Conclusion
Yerlika is committed to advancing the localization of biopharmaceutical production, reducing reliance on imports, and fostering a self-sufficient ecosystem for cutting-edge biotechnology in Turkey. By integrating innovative technologies, world-class expertise, and robust collaborations, the company is positioning Turkey as a leading hub in the global biotechnology and life sciences sector.
Through strategic investments in FOBs/biosimilars, monoclonal antibodies, gene therapies, and vaccine production, Yerlika is driving significant scientific and industrial advancements. These efforts ensure that patients gain greater access to high-quality, life-saving treatments. The company’s unwavering commitment to GMP, regulatory excellence, and process optimization solidifies its reputation as a trusted CDMO partner for both local and international stakeholders.
As a forward-thinking biotechnology enterprise, Yerlika actively collaborates with governmental institutions, research organizations, and global pharmaceutical companies to shape the future of health care. By embracing new molecular developments and pioneering high-impact biotechnological solutions, Yerlika reinforces its role as a catalyst for scientific and economic growth in Turkey.
With a steadfast focus on innovation, accessibility, and sustainability, Yerlika Biopharma is not only transforming biopharmaceutical production in Turkey but also expanding its influence on the global stage. As the company continues to scale its capabilities, it reaffirms its mission to establish Turkey as a globally recognized biotechnology hub. By bridging the gap between science, industry, and patient care, Yerlika is paving the way for a healthier, more advanced future for all.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘follow-on biologicals’ approved in Turkey might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Competing interests: This paper was funded by Yerlika.
Provenance and peer review: Article prepared based on the interview conducted on 6 March 2025; internally peer reviewed.
Author
GaBI Journal Editor
Disclosure of Conflict of Interest Statement is available upon request.
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