”Small Molecule API Contract Manufacturer Quality Benchmarking (2016)” — quality benchmarking reports now available

Suite of reports provide readers with a comprehensive assessment of biopharmaceutical CMO service quality across three key areas of outsourced manufacturing: small molecule, biologic and fill finish.

These reports provide a Consumer Reports-style analysis where each of the 83 CMOs included in the research was evaluated across 26 service quality attributes, making these reports the most comprehensive assessment of quality in the contract manufacturing space. These 26 attributes were categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities, and Staff Characteristics. Respondents were asked to recall their specific experiences working with the manufacturers, and to indicate how well the manufacturer(s) performed with respect to expectations. For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for small molecule, biologic or fill finish projects from early clinical stages to commercialization.

"There has been a tendency to conflate CMOs' service offerings when it comes to performance evaluations, especially in syndicated research," explained Kate Hammeke, Director of Market Research at Industry Standard Research. "That approach makes it easier to acquire the desired sample size to conduct an analysis, but the insights lack the depth of information both sponsors and contract manufacturers crave. Starting this year, ISR's Contract Manufacturer Quality Benchmarking research has been split into three tracks of data collection, enabling sponsors to evaluate CMOs on specifics related to the type of project for which the CMO was engaged, whether it was for small molecule API, biologic API or fill finish. This depth of information and audience-actual customers who have worked with the CMO in the past 18 months-has previously only been available through custom market research."

CMO performance attributes evaluated by respondents include Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others.

The reports include data on 83 different contract manufacturing organizations, including: 3M Drug Delivery Systems, AAI/Cambridge Major, AbbVie Contract Manufacturing, Aenova, Aeras CMO, Aesica, AMRI, Albemarle, Almac, Althea, AMPAC Fine Chemicals, Aptuit, Ash Stevens, Avid Bioservices, Baxter BioPharma Solutions, BioReliance, Boehringer Ingelheim, Cambrex, Capsugel, Catalent, Celltrion, Chartwell Pharmaceuticals, CMC Biologics, Cobra Biologics, Cook Pharmica, Corden Pharma, CoreRx, CPL, Cytovance Biologics, Dalton Pharma Services, DPT, Dr. Reddy's CPS, Ei, Emergent Biosolutions, Evonik, Fareva, Flamma, FujiFilm Diosynth Biotechnologies, Glatt Pharmaceutical Services, GSK Contract Manufacturing, Halo Pharma, Helsinn, Hetero, Hospira One2One, Hovione, IDT Biologika, Jubilant HollisterStier, KBI Biopharma, Kemwell, Lonza, Metrics, Neuland, NextPharma, Norwich, Novasep, Paragon, Patheon, PCI Synthesis, Pfizer CentreSource, PharmaCore, Pharmatek, PharmaZell, Pii, Piramal Pharma Solutions, Recipharm, Rentschler, Richter-Helm, Rottendorf Pharma, SAFC, SAI Life Sciences, Samsung BioLogics, Sandoz, Sanofi CEPiA, Siegfried, Symbiosis, Therapure BioPharma, Unither Pharamceuticals, UPM Pharmaceuticals, Vetter, WellSpring, Wockhardt, Xcelience.