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Contract Manufacturing compliance. Following close behind would be regulatory adher- ence, for the same reason. Productivity is easier to attain, assuming the CMO has all of its other systems in place. Innovation can be a double-edged sword in a CMO. If applied to improved operational systems and problem solving, innovation is a positive attribute. If the CMO tries to innovate on a client's process, however, it can lead to delays and unforeseen changes in a transferred process. HOW DO YOU ASSESS A CMO AS POSSESSING THE ATTRIBUTE OF INNOVATION? Alonso-Caplen: A CDMO (contract development and manufac- turing organization) would score high on innovation when the organization can offer practical solutions to improve processes, products, technologies, or services needed by their client, on top of continuing to meet quality, regulatory, reliability, and produc- tivity attributes. Rosenblatt: A CMO that has the ability to adapt its internal procedures to meet the sponsor's needs (i.e. introduction of a novel technol- ogy or piece of equip- ment into its facility) is one good indica- tor of innovation. Companies that can offer suggestions on operational practices a late-stage product, a list of success criteria is included. Delivery of the required number of engineering and GMP runs on time, within budget, and meeting all of the success criteria, exemplifies a CMO's excellence in productivity. Rosenblatt: Productivity is linked to capacity, quality systems, adherence to regulatory requirements (no citations or 483 notic- es), and delivery of product on schedule with minimal or no devia- tions. Examination of deviation history, regulatory inspections, and plant utilization, measured against the total number of past projects, will result in a reasonable estimation of the productivity of the operation. HOW DO YOU ASSESS A CMO's QUALITY? "Many sponsors place a great deal of emphasis on the experience of the [CMO's] senior most staff, without assessing the experience of the technical staff." Barry Rosenblatt, Ph.D., SME Biotech Consulting to increase efficiency/decrease costs of goods (i.e. use of bar cod- ing for tracking raw materials/samples/products) demonstrate innovative thinking. DESCRIBE A SITUATION OF A CMO DEMONSTRATING THE ABILITY TO BE INNOVATIVE? Alonso-Caplen: A CMO that is able to significantly decrease the number of purification steps of a product, with concomitant increase in overall yields, is an example of innovation. Rosenblatt: In one project, the process required the use of mul- tiple bioreactors feeding into a common capture step in a semicon- tinuous process. The CMO room design was originally set up for contiguous USP/DSP suites using dedicated feed lines between the rooms. The CMO used an innovative modification of the feed lines to redirect the feed stock from two rooms into a single DSP suite, bypassing the intermediary rooms. WHAT IS THE BEST WAY TO MEASURE A CMO's PRODUCTIVITY? Alonso-Caplen: Typically, when drafting a service agreement for 12 The CMO Leadership Awards 2012 Alonso-Caplen: The CMO has to undergo a two-to-three day audit by our QA auditors, depending on the complexity of the project that will be outsourced. A team of two to three auditors, includ- ing an outsourcing SME (small to medium enterprise), will assess the CMO's quality sys- tems. A typical start- ing point for an audit is the warehouse, where raw materials and components are received, go through the production and testing process flow and associated quality systems and facilities, and end with storage areas for either bulk drug substance or for drug product. Rosenblatt: Assessment of the quality of a CMO is focused on the quality systems in place. Reviewing the SOP structure during an audit (i.e. policies, SOPs, batch records), as well as the content of each is essential for establishing trust in the CMO's understanding of quality. Other essential pieces include a change-control system, OOS (out of specification)/deviation system, sample tracking sys- tem, external vendor audits, process/equipment/people flow pro- cedures, and personnel training. Every audit should contain a spot check of documentation to determine whether SOPs are being fol- lowed. Inspection records from regulatory agencies (observation and/or 483 letters) should also be examined. Lastly, philosophy of the quality group and CMO management should be compared to the philosophy of the sponsoring company, with any disconnects covered in a quality agreement. WHAT IS THE BEST PREDICTOR OF A CMO's RELIABILITY? Alonso-Caplen: Reliable CMOs will meet all project milestones