Bringing new pharmaceutical products to market is a time consuming and costly process and identifying reliable and effective contract development and manufacturing organizations to work with new drug developers helps significantly streamline that procedure. The Life Science Leader CMO Leadership Awards, based on collected data from the Industry Standard Research (ISR) Contract Manufacturing Quality Benchmarking annual survey, is designed to better serve biopharmaceutical executives in their CMO selection process.
ISR evaluates more than 80 CMOs and limits respondents to evaluating only those companies with which they have worked within the previous 18 months. This level of qualification ensures that quality ratings are based on actual, recent involvement with an organization that is backed by experiential data and provides executives an efficient means of vetting potential CMO partners who are considered most reputable in the industry. The five award core categories include:
Capabilities--the CMO facilities has most up-to-date manufacturing technologies; Full range of manufacturing for required dosage forms; Proven ability to manufacture API; Provides regulatory support for filing; Stability testing and storage capabilities.
Compatibility--the CMO provides core competencies complementary to in-house or other manufacturing contractors; Access to desired markets; Cultural fit including accessible senior management and timely project communications; Well-regarded within the industry.
Expertise--the CMO provides an experienced level of staffing and scientific knowledge that offers innovative solutions; Consistently demonstrates the ability to scale up manufacturing and transfer technology.
Quality--the CMO provides strong track records for regulatory compliance, right first time measurements, and meeting quality performance metrics.
Reliability--the CMO fully owns their own facilities and exhibits: financial strength and stability; Capacity to meet demand; Up-front contingency planning and risk management; Flexibility to adjust to special requests; Reliable project management procedures and a record of on-time delivery.
Additionally, eight Specialty Award Categories, each based on single a performance metric, were awarded. CMC Biologics received awards for the two significant categories State-of-the-Art and Innovation, both sponsored by Thermo Fisher Scientific.
About CMC Biologics
CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality--Right and On Time. With facilities in the USA and Europe, the Company is a global CMO that provides fully integrated biopharmaceutical development and manufacturing solutions to clients around the world. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.
For further information, please contact:
Robert Broeze, PhD
Senior Vice President, Global Business Development, CMC Biologics
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SOURCE CMC Biologics