Third party manufacturing / Loan License Manufacturing /Commercial manufacturing
Biotime offers third party GMP manufacturing, Loan license manufacturing and Commercial GMP manufacturing. Our custom manufacturing use a variety of manufacturing approaches to make only the product you need. We offer contract manufacturing services for big pharma companies, wholesalers and marketing companies.
Clinical trial manufacturing
Our Tailor manufacturing, packaging approach for clinical trial supplies is extremely flexible to reflect your clinical trial design.
Process validation and Registration Batches
We can support all aspects of drug product supply and provide regulatory support for national and international applications. We adhere to WHO and global FDA GMP regulations.
Third party manufacturing / Loan License Manufacturing /Commercial manufacturing
Biotime offers third party GMP manufacturing, Loan license manufacturing and Commercial GMP manufacturing. Our custom manufacturing use a variety of manufacturing approaches to make only the product you need. We offer contract manufacturing services for big pharma companies, wholesalers and marketing companies.
Clinical trial manufacturing
Our Tailor manufacturing, packaging approach for clinical trial supplies is extremely flexible to reflect your clinical trial design.
Process validation and Registration Batches
We can support all aspects of drug product supply and provide regulatory support for national and international applications. We adhere to WHO and global FDA GMP regulations.
Technology transfer
Technology transfers are not always straightforward, especially if the product and processes are being transferred between different organizations or onto different types of equipment. With integrated capabilities, we ensure a quick and seamless approach to technology transfers. For transfers from an existing provider or even some products that may require certain equipment or processes, our project team will start by gaining a deep understanding of the history of the product. With this foundation, we will work with the customer to develop and implement the product development plan.
Scale up
Biotime supports clients at all stages of development and has a team with a strong track record of scaling up from lab and pilot scale to commercial batch sizes. Maintaining product quality and robustness is essential. A team of dedicated formulation and process experts support the identification of critical process parameters (CPP) and critical quality attributes (CQA). Understanding these factors early in formulation and process development is key for successful scale-up. By systematically developing an understanding of the product and process, we help clients to build robustness and quality into the final formulation.
At a glance
- Third party manufacturing and Loan license manufacturing
- Formulation development and process optimization development
- Transfer and qualification of analytical methods
- Technology transfer from lab scale to pilot scale to commercial manufacturing
- Transfer existing products and processes from another contract development and manufacturing organization (CDMO)
- Cleaning method development, verification and validation
