We're a trusted and established specialist GMP manufacturer providing aseptic fill and finish services for Antibody Drug Conjugates (ADCs).
Overcome your development and manufacturing challenges with a partner that has the experience and capabilities to handle your highly-potent ADC manufacturing project.
Our industry experts and dedicated containment suite for GMP aseptic filling are equipped to handle a range of Safebridge® category ADCs up to category 3 in clinical and small-scale commercial batches.
Targeting therapies to specific cells or areas within the body is a concept that stretches back more than a century, especially for the treatment of cancer. However, the side effects from targeted cancer chemotherapies are often associated with non-specific toxicity on healthy cells and tissues when administered systemically.
Over the past 30 years, the development of monoclonal antibody (mAb) treatments specifically targeting cancers has made it possible to fuse (or conjugate) toxic payloads to ensure localized targeting of cancers. In turn, this minimizes non-specific toxicity to the patient. While most ADCs are designed for cancer treatments, there is a number in development to treat other ailments such as arthritis.
The three components of antibody-drug conjugates are:
Antibody: This directs the payload to the target of interest, typically in the form of a mAb, but could be a smaller antibody fragment.
Payload: This is the entity or “drug” which delivers the desired therapeutic response. For most ADCs this would be a high potency or cytotoxic API.
Linker: The component which joins the antibody to the drug. These can be cleavable, meaning they are designed to separate from the antibody at the target site. Linkers can also be non-cleavable and remain linked to the antibody.
We have extensive experience in taking precious, complex drug products from manufacture to QP release.
Clinical and small scale commercial manufacturing of advanced therapeutics such as viral vectors for cell and gene therapies, oncolytic viruses and critical raw materials such as plasmids.
Extensive experience in delivering hundreds of projects allowing us to support your clinical trials.
Symbiosis can support with challenging manufacturing and handling requirements that need specialist knowledge and experience.
Symbiosis has provided GMP manufacturing across a wide range of small molecule applications, including highly potent materials requiring specialist handling.