Immobilisation Technology for Next Generation Antibodies
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  • qm1w2 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. qm2w2
  • qm1w2g Lock-Release features smaller production and containment footprints, minimized risk to high value drug components, lower costs and reduced environmental impact. qm2w2

ADC Biotechnology at-a-glance:

ADC Bio is developing new process technology to help drug developers meet conjugation process challenges in the testing and production of new antibody drug conjugate (ADC)-based anti cancer drugs. The technology signals faster, simpler and less costly development for an exciting new family of drugs.

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.

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By 2015/16, the combined annual sales and production market for ADC drugs is projected to top US $8bn. ADC Bio's mission is to provide a superior conjugation technology platform that enables a new generation of anti-cancer therapeutics and diagnostics... offering rapid conjugation screening, efficient processing and improved development and production economics to drug innovators....

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  Latest News

9 October 2015

US$10m cancer drug production expansion

ADC Bio has announced a $10m (GB£6.5m) plan to build a 1,500 m2 manufacturing facility for advanced anti-cancer drugs.

The two-stage expansion program marks the transition of ADC Bio into GMP manufacturing of ADCs (antibody drug conjugates) and will create over 60 new science jobs at completion.

The investment responds to demand by drug developers and a shortage of capacity to make these new drugs in quantities sufficient for large scale clinical trials.

Phase 1 of the project will come on stream in mid-2017, creating a 1,500 m2 state-of-the-art, dual-stream facility for process development, manufacturing and quality testing of ADC drugs.

From both scale and regulatory perspectives, the new facility will be able to produce clinical trial and low-volume commercial quantities. Production will be in cutting edge cleanroom facilities, accommodating both ADC Bio’s proprietary “Lock-Release” technology and conventional, solution-phase production.

The facility will bring process development, manufacture, quality control, quality assurance and stability testing together under one roof at ADC Bio’s operational headquarters in St Asaph, North Wales.

A projected second phase is planned to add another 2,500m2 of manufacturing space for larger scale clinical and commercial manufacturing.

Over the past two years, the company has trebled its tech service lab space and science staff. Completed in early 2015, a £100,000 development added a second R&D lab, focused on bio-conjugation and payload-linker chemistry, and reflecting rising demand for the company’s technical services.

Dr. James Davies MP (left), newly elected Conservative member for the Vale of Clwyd, recently visited the newly-extended labs atSt Asaph. He was hosted by Chief Technology Officer Dr. Dave Evans (right) and Non-Exec Chairman Dr Pete Jackson.

Dr. James Davies MP (left), newly elected Conservative member for the Vale of Clwyd, recently visited the newly-extended labs at St Asaph. He was hosted by Chief Technology Officer Dr. Dave Evans (right) and Non-Exec Chairman Dr Pete Jackson.

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