SCIEX and Dalton Pharma Services Collaborate to Advance Antibody-Drug Conjugate Analysis

Research collaboration to develop Antibody-Drug Conjugate (ADC) analysis capabilities

Toronto — SCIEX and Dalton Pharma Services (Dalton) announced today a research collaboration to develop Antibody-Drug Conjugate (ADC) analysis capabilities. This will include development of more definitive and comprehensive method for the identification of drug loading and position of conjugation on macromolecules. This collaboration is part of SCIEX's commitment to support the growing movement to bring targeted antibody-based therapies to market.

Our collective goal is to help our customers bring drugs from concept to market faster. The collaboration provides SCIEX, a global leader in life science analytical technologies, with the specialized synthetic conjugation capabilities of Dalton. The research includes the preparation and characterization of ADC's by Dalton scientists working with SCIEX experts to develop standardized analytical procedures on the TripleTOF^® 5600+ system with SelexION™ technology and the new TripleTOF^® 6600 platform for determining the chemical structures of conjugated molecules.

"A key challenge for developing successful Antibody-Drug Conjugate medicines is understanding the structure and payload of the final molecule. Determining where the drug attaches to a particular antibody early in its development and the number of drug molecules on the antibody are important indicators of the likely success of a new ADC," explained Tan Quach, Chemistry Manager at Dalton Pharma Services.

"Recent advances in mass spectrometry have provided a solution to answer the challenging questions in terms of understanding ADC drug development and working within a biological matrix," said Chris Radloff, Vice President, LC/ MS Business at SCIEX. "Utilizing these molecules is difficult and by forming this partnership, ADC developers can now reduce complications, and obtain accurate results that will ultimately lead to safer, more effective therapies."

Results of the first phase of the collaboration were featured at ASMS 2014 in Baltimore. The partnership will continue to co-develop standardized analytical procedures utilizing the MS technology that delivers consistent results when compared with ELISA and publish technical papers over the next upcoming months.

About Dalton

Dalton Chemical Laboratories, Inc., o/a Dalton Pharma Services, is a GMP contract manufacturer that supplies chemistry, analytical and formulation development services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry and fine chemical manufacture. Dalton offers custom conjugation services as a tool for drug delivery, including development of antibody-drug conjugates (ADCs).  Dalton provides cGMP manufacturing of solid dosage forms and aseptic filling services to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its modern cGMP facilities, Dalton performs sterile powder filling and sterile crystallizations, and produces sterile active pharmaceutical ingredients (APIs) at the gram or kilogram scale.  Dalton conducts aseptic fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions. In addition, Dalton's analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients.

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