Pharma Companies and CMOs Invest in ADC Technology

Antibody drug conjugates (ADCs), which consist of a cytotoxic small molecule linked to a monoclonal antibody, are drawing the large pharmaceutical companies and contract manufacturers. AstraZeneca, Roche, and SAFC are among the latest companies to invest in ADC technology.

This week, MedImmune, the global biologics R&D arm of AstraZeneca, announced it had acquired Spirogen, a privately held biotechnology company focused on ADC technology for use in oncology. MedImmune has also entered into a collaboration agreement with ADC Therapeutics to jointly develop two of ADC Therapeutics’ antibody-drug conjugate programs in preclinical development.

MedImmune will make an equity investment in ADC Therapeutics, which has an existing licensing agreement with Spirogen. MedImmune will acquire 100% of Spirogen’s shares for an initial consideration of $200 million and deferred consideration of up to $240 million based on reaching predetermined development milestones. Existing out-licensing agreements and associated revenue streams are excluded from this acquisition. MedImmune will also pay $20 million for an equity investment in ADC Therapeutics, which will be matched by Auven Therapeutics, the majority shareholder in both ADC Therapeutics and Spirogen. The collaboration agreement will include an upfront payment with predetermined development milestones for two programs from a defined list and a cost- and profit-sharing arrangement with MedImmune representing the majority share. ADC Therapeutics will also have the option to copromote one of the products in the US.

As part of a larger biologics manufacturing investment, Roche plans to construct an antibody-drug conjugate (ADC) production facility in Basel, Switzerland through an investment of more than CHF 190 million ($209 million). This investment will provide additional capacity and flexibility to support Roche’s first approved ADC, Kadcyla, and a further eight ADCs in clinical development.

Sigma-Aldrich's custom-manufacturing services business unit, SAFC Commercial is expanding two of its manufacturing facilities in the United State: The company is investing in commercial-scale manufacturing capacity for ADCs at its facility in St. Louis, Missouri and is expanding its high-potency API (HPAPI) manufacturing and storage capacity at its facility in Verona, Wisconsin. Additional commercial-scale manufacturing capacity has also been designed to accommodate future growth in demand for ADC production.

Earlier this month, Carbogen Amcis announced an investment of $4-million to expand its cleanroom clinical-supply facility at its Bubendorf, Switzerland. The Bubendorf facility features a new 100-m² ADC cleanroom suite for the development and production of ADC clinical material under cGMP and contains Grade D and Grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m³ at 8-hour time weighted average (8h-TWA). In 2012, Carbogen Amcis and ADC Biotechnology (ADC Bio) partnered for ADC development and manufacturing services.

In January 2013, Lonza announced plans to invest CHF 14 million ($15 million) to expand ADC manufacturing capacity at its site in Visp, Switzerland. The expansion of the ADC facility will double the company's existing large-scale manufacturing capacity in Visp. The expansion is expected to be completed in the second quarter of 2014.

In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for ADC production, whereby the two parties will offer contract development and manufacture of ADCs. Piramal offers ADC production at its site in Grangemouth, Scotland. Piramal recently invested $2.5 million at is Grangemouth site to upgrade one of its ADC manufacturing sites from clinical phase to commercial grade. The upgrade gives Piramal two commercial grade ADC suites at the Grangemouth facility while retaining clinical phase manufacturing capacity in other suites on site.