Contract Manufacturing Organization

Your clients depend on you to manufacture their product to meet clinical and market supply demands, and in many cases, CMOs are also involved in the testing that ensures the safety and efficacy of the manufactured product.

Contract Manufacturing Organization

Contract manufacturing organizations' work may involve performing the work in-house or using a trusted CRO to outsource testing to. Other options to consider are qualifying a vendor to handle overflow work for you or looking at insourcing options.

Clean rooms, including manufacturing suites, must be kept in a state of microbiological control. This is accomplished by introducing and maintaining a sound cleaning and sanitization program within these controlled environments to prevent the microbial contamination of the products being manipulated. Routine environmental monitoring of the manufacturing suites allows you to continue to monitor the state of control of your facility.

Products & Services

Charles River is a partner you can trust to ensure the quality, consistency, and integrity of cell banks. With more than 20 years of experience in GMP cell banking, our skilled team is able to provide a smooth and successful outcome for your cell banking campaign and then provide the appropriate package of characterization studies, allowing you to move those cells in product production runs in a timely manner.

Products & Services

As an advanced analytical laboratory, Charles River serves clients who require expertise in recombinant glycoprotein and complex biologics characterization services. We specialize in a broad range of analytical testing techniques to support characterization and development of both recombinant protein and peptide therapeutics. Our team of experts, complemented by our cutting-edge technology, supports our clients while upholding the highest standards of quality, technical analysis, and reporting.

Products & Services

The complex infrastructure of biologics leads to specialized methods being needed to determine their potency. In vivo and in vitro bioassays begin during the early development phase of a biologic with method development efforts and extend throughout its whole life cycle including lot release testing during commercialization efforts.

The intricate nature of large molecules can make it difficult to perform bioassays and achieve reliable results. Charles River delivers consistency with extensive experience in the establishment, validation, and conduct of routine bioassays to GMP standards. We provide comprehensive coverage, offering both in vitro and in vivo bioassays for a variety of biologically active molecules.

Products & Services

As you strive to improve efficiencies and reduce costs, it is wise to evaluate strategic sourcing initiatives, including closer collaboration with contractors. The RightSource℠ program is a scientific staffing program that provides flexible insourcing/outsourcing options for biologics developers and manufacturers. We work with you to evaluate your QC testing programs and select the best-suited, most affordable mix of insourcing and outsourcing options.

Products & Services