Symbiosis has extensive experience and a proven track record in taking complex drug products, ranging from small molecules to mABs and ATMPs, from aseptic manufacturing through to QP release.
The development and production of injectable drug products is challenging. Finding a suitable GMP fill-finish manufacturer with the knowledge and experience in how to deliver drug projects in short timelines can be difficult.
That challenge can be compounded when seeking a manufacturing partner with the technical know-how and expertise to handle advanced therapeutics such as viral vectors or antibody drug conjugates.
Symbiosis has extensive experience in taking drug products through manufacturing, testing, label and packaging, storage, distribution and QP release. Our expert project management team offers a single point of contact throughout each project, ensuring that communication happens as clearly and as frequently as you need.
Having established the production and purification processes for your drug substance, it then needs to be transferred and manufactured in an environment that protect the product, meaning it can then be administered to the patient in a reliable and safe manner.
Consideration must be given to the final composition (e.g. buffers and any other additives) as well as any special handling and storage requirements for your product. The container system must also be considered as some therapies, especially the advanced therapies, have limited compatibility with traditional glass vials.
Symbiosis has a range of validated options which can be used to successfully deliver your product to the patient quickly.
