Summary
- Profile Type
- Business Offer
- POD Reference
- BOTR20240515006
- Term of Validity
- 15 May 2024 - 15 May 2025
- Company's Country
- Turkey
- Type of partnership
- Commercial agreementSupplier agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- The Turkish Company, leading CMO and CDMO service provider based in Turkey, the company specializes in providing process development, manufacturing, filling and finishing services. With its GMP certified facility (for 8 biotechnological products) and experienced team, it ensures the highest quality and compliance standards. Facilities involved in API manufacturing and/or F&F facilities have proven expertise in sterile biotech drugs/vaccines and chemical-based dermophiles for human use.
- Full Description
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The Turkish company was established in November 2016 with the aim of producing biotechnological drugs in Turkey and exporting biotechnological products to the whole world, including Europe. The facility was opened on June 13, 2019. The Production Facility is built on an area of 4215 m2 and has 7112 m2 closed and 1750 m2 clean area. In February 2020, it was inspected by TITCK inspectors and the production site permit and GMP certificate for biotechnological production were obtained. In 2020, it started to develop the vaccine project together with TÜBİTAK in order to meet the vaccine need in the country due to the Covid-19 epidemic, and in this context, the factory was inspected in December 2020 and the production of the adenovirus vector was carried out. based vaccine has been launched. Added to GMP certification. It has a production capacity of 20 kg mAb with 500L disposable bioreactor technology, and with its annual filling capacity exceeding 2.5 million, it provides services to domestic/foreign companies in addition to its products, at GMP standards.
It serves as both a Contract Development and Manufacturing Organization (CDMO) and a Contract Manufacturing Organization (CMO). A CDMO offers a comprehensive suite of services, including process development and pilot-scale production for biopharmaceuticals as well as adenovirus vector-based vaccines. As a CMO, it offers formulation and filling services for dermofil projects, supported by stringent quality control and stability testing protocols.
In light of their proven track record, state-of-the-art infrastructure and unwavering commitment to excellence, they are actively seeking strategic and commercial partnerships. Through these collaborations, it aims to provide support to its partners at all stages of process development, production, formulation, filling and quality assurance processes. The Turkish company believes that, with its experienced and comprehensive customer-specific service agreements, they can significantly simplify their partners' product launch journey, thus promoting mutual success and growth.
It looks forward to the opportunity to further explore potential collaborations and stands ready to discuss partnership opportunities as soon as possible. - Advantages and Innovations
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The Turkish Company facilitate your avoidance of substantial investments typically associated with adhering to Good Manufacturing Practices (GMP) standards for biopharmaceutical product production.
The provide assistance in the complex processes of biosimilar product development and production, alleviating the necessity to specialize in this intricate field.
The company is leveraging extensive expertise, offer robust capabilities in GMP manufacturing and formulation of monoclonal antibodies, recombinant proteins, hormones, peptides, and adenovirus vector-based products, ensuring prompt and dependable service delivery.
It takes advantage of Turkey's strategic geographical location to develop its ability to distribute products to international customers quickly and efficiently.
The company is competitive advantage reflects their ability to provide services at more affordable prices due to lower operating costs compared to other European and Asian countries.
By using policies that encourage the Turkish government's Research and Development (R&D) and innovation activities, they facilitate the increase of R&D investments and the development of innovative products.
It offers positioning for wider opportunities and success by strengthening the growth potential in the biopharmaceutical sector with the developing Turkish economy.
With its adaptable approach, the Turkish company ensures that the most suitable solutions are offered by offering special services tailored to fully meet specific needs.
It accelerates and streamlines support processes with comprehensive service offerings, including optimization of shake flasks, wave bioreactors and disposable bioreactors for rigorous process development studies.
By establishing collaborative partnerships in clinical or commercial manufacturing efforts, they enable them to realize joint success and achieve growth goals. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 8: Decent Work and Economic GrowthGoal 17: Partnerships to achieve the GoalGoal 12: Responsible Consumption and Production
Partner Sought
- Expected Role of a Partner
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Within the scope of Contract Manufacturing Organization (CMO) agreements, the Turkish company, known as the leading organization in GMP biotechnological drug production in Turkey, creates clear expectations for potential business partners.
Firstly, it is imperative to strictly comply with established quality standards and regulatory requirements throughout the production process. This requires unwavering compliance with stringent Good Manufacturing Practice (GMP) guidelines set by local regulatory authorities. It also expects its partners to demonstrate flexibility, adaptability and responsiveness in adapting to specific production needs and timelines. Given the dynamic nature of the pharmaceutical industry, agility in adjusting production schedules and effectively addressing unforeseen challenges is crucial.
Effective communication is the cornerstone of success in collaborative efforts. Therefore, it is crucial that potential partners maintain transparent and open lines of communication, providing regular updates on production progress, potential challenges and deviations from agreed-upon specifications. Timely and comprehensive reporting not only facilitates proactive problem solving but also ensures compliance with overall production goals.
It also expects partner companies to prioritize continuous improvement initiatives aimed at increasing efficiency, reducing production costs and optimizing product quality. Active participation in process optimization and technology integration efforts is essential. This not only contributes to the sustainable growth and competitiveness of joint operations, but also underlines the commitment to excellence. Additionally, a commitment to innovation and research-based solutions fosters a culture of excellence, placing partnerships at the forefront of drug development.
In summary, the Turkish company emphasizes the importance of cooperation and partnership integrity in CMO agreements. By adhering to the expectations outlined, potential partner companies not only play an important role in the success of individual projects, but also expect to contribute to increased partner reputation and long-term sustainability in GMP production. This transparent articulation of expectations ensures that potential partners understand the sponsor's standards of excellence and are aligned with their commitment to deliver high-quality products in the pharmaceutical and healthcare industries. - Type and Size of Partner
- Big companyR&D InstitutionSME 11-49SME 50 - 249SME <=10UniversityOther
- Type of partnership
- Commercial agreementSupplier agreement
Call details
- Coordinator required
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Yes
Dissemination
- Technology keywords
- 06006012 - Bioprocesses06001015 - Pharmaceutical Products / Drugs06001003 - Cytology, Cancerology, Oncology06001007 - Emergency medicine03004007 - Pharmaceutics
- Market keywords
- 04001002 - Industrial genetic engineering applications04001004 - Other recombinant DNA04002 - Monoclonal Antibodies and Hybridomas09004001 - Business products and supplies05007002 - Pharmaceuticals/fine chemicals
- Sector Groups Involved
- Health
- Targeted countries
- All countries