With surging numbers of "second generation" drugs in development (currently around 200) tumour-selective ADCs are building a significant position in the oncology field – the fastest growing sector in healthcare.
For ADC developers, the key pre-clinical challenges for regulatory compliance with Chemistry Manufacturing Controls notably include unwanted aggregation, achieving the right Drug Antibody Ratio (DAR), a shortage of conjugation-qualified CMOs and removal of unbound drug from the product.
Reaching an optimal DAR and limiting aggregation to acceptable levels are closely linked, and ADC Bio's Lock-Release technology has proven to be a key product enabler in meeting this twin challenge. Lock Release facilitates maximum cell killing efficacy at higher DARs and at a quality - minimal aggregate and unbound drug - suitable for pivotal pre-clinical and clinical testing.
By effectively addressing these and other challenges, ADC Bio's technology aims to become a new paradigm in the way ADCs are developed and manufactured, increasing accessibility for patients by helping to contain ADC production complexity and cost.
ADC Bio's patented Lock - Release technology results in fast, simple and robust conjugation processes, with the potential to eliminate several process steps whilst enhancing product quality.
Following a successful proof-of-concept programme ADC Bio secured a £450,000 package of investment and grant funding in late 2011. A £600,000 second round investment and grant package was announced in January 2013.
Prototype Lock - Release platforms are currently under evaluation by key clients.
ADC Bio brings knowledge, experience and technical differentiation to the rapid growth ADC sector and is an ideal partner for basic research, development, scale-up and commercialisation challenges.