Manufacturing

Lab samples for multigram needs (GMP and non-GMP)

Nuvisan delivers high-quality manufacturing solutions tailored to meet the needs of the pharmaceutical and biotech industries. With a focus on innovation, compliance and efficiency, our capabilities cover a broad range of requirements: 

• Flexible scale: From gram scale to kilogram production.
• Expertise in high-potency compounds: Specialised handling and containment for HPAPIs and controlled substances.
• Regulatory excellence: Manufacturing under GMP standards that helps ensure compliance with international guidelines, when needed.
• Customised solutions: Adaptable processes to support unique project needs.
• Seamless integration: Close collaboration with our R&D and analytical services for end-to-end support. 

Nuvisan’s state-of-the-art facilities and dedicated teams ensure reliable and efficient manufacturing to accelerate your path to success. 

Kilolab for Kg scale needs (GMP and non-GMP)

Our comprehensive range of services, from process development to batch production, enables fast and efficient delivery of your drug substance. Both process development and kilogram-scale batch manufacturing are carried out at the same site by our highly skilled and flexible team of scientists. This integrated approach helps ensure timely delivery of pre-clinical supplies, while streamlining and reducing the costs of your clinical supplies.

We can produce batches ranging from 0.1 to 10 kg of intermediate or API in our kilo-lab, with rigorous impurity control to support pre-clinical studies. Our detailed batch records and technical package help facilitate a smooth transfer to a CMO for larger-scale API production. 

In-process control

In-process control (IPC) refers to monitoring and testing of parameters during the manufacturing process to help ensure the quality, consistency and safety of a drug substance.

At Nuvisan we offer: 

• Advanced analytical methods: Use of techniques like HPLC, SFC, NMR and XRPD to monitor conversion.
• Regulatory compliance: All IPC are designed to meet GMP standards and ensure smooth regulatory submissions. 

By incorporating robust IPC, Nuvisan can enhance the efficiency, reliability and quality of your product, ensuring that the drug substance meets all necessary specifications throughout the production lifecycle. 

Orphan drug batches

Nuvisan offers services for the development and production of orphan drug batches, helping ensure that your rare disease treatments are delivered with the highest standards of quality and compliance.

• Small-scale production: Custom batch sizes (from 0.1 to 10 kg) tailored to orphan drug needs. 
• Regulatory expertise: Full compliance with GMP standards.
• Flexible manufacturing: Our highly qualified team provides flexible, fast-track production to meet urgent timelines and specific project needs.
• Quality control: Rigorous in-process controls and testing improves batch purity, stability, and consistency.

Nuvisan's orphan drug manufacturing expertise helps you overcome rare disease treatment challenges, supporting your product's safety, efficacy and availability.