In a pioneering initiative, São Paulo State University (Unesp) will inaugurate on June 13th the first Contract Development and Manufacturing Organization (CDMO) with a Good Manufacturing Practices (GMP) environment in Latin America. Located in Botucatu, 230 km from São Paulo, the facility will be operated by the Center for the Study of Venoms and Venomous Animals (Cevap) and will focus on the development and production of biological medicines.
This new CDMO aims to provide specialized services to the pharmaceutical industry, producing pilot batches of biopharmaceuticals for clinical trials in a validated environment. Additionally, the facility will house a school for professional training and qualification in Good Manufacturing Practices (GMP) and offer space for biotechnology startups.
What is a CDMO?
A CDMO, or Contract Development and Manufacturing Organization, offers outsourced development and manufacturing services for pharmaceutical, biotechnological, or research companies. CDMOs are essential partners in assisting companies with the creation, development, and production of medicines, from initial research phases to commercial manufacturing and distribution, always adhering to regulatory guidelines.
Importance of CDMOs
CDMOs are valuable partners for pharmaceutical and biotechnological companies, offering a wide range of services that cover research and development, manufacturing, quality control, regulatory affairs, logistics, and distribution. They are particularly useful for companies that:
1. Have promising medicines but lack manufacturing capacity.
2. Need to quickly scale up production.
3. Are developing complex medicines with stringent regulatory requirements.
4. Seek flexibility and cost reduction.
5. Aim to rapidly launch new medicines or expand into new markets.
6. Prefer to focus on their core competencies and outsource manufacturing.
Services Offered
Key services provided by CDMOs include:
• Research and Development: Formulation and development of medicines, stability studies and analytical testing, process development, and optimization.
• Manufacturing: Small and large-scale production, manufacturing of various pharmaceutical forms, sterilization, and packaging.
• Quality Control: Rigorous quality testing to ensure compliance with regulatory standards, process monitoring, and batch release.
• Regulatory Affairs: Assistance in obtaining regulatory approvals and compliance with international standards (GMP).
• Logistics and Distribution: Storage, transport, and distribution of medicines
A Growing Sector
The global market for biological medicines is experiencing significant and steady growth, with projections for 2024 estimating values up to US$ 300 billion. In Brazil, this sector moved approximately R$ 40 billion in 2023, with continuous growth expected.
The inauguration of the CDMO at Unesp marks a crucial moment for the research and production of biopharmaceuticals in Brazil. This innovative project offers essential infrastructure for the development of high-quality medicines. It will boost Brazilian biopharmaceutical production.
Source: G1
