Our background with recombinant proteins and
monoclonal antibodies
- Our protein scientists have successfully developed dozens
of recombinant proteins and monoclonal antibodies (mAbs)
through preclinical, clinical and commercial stages
- RMC’s experts understand state-of-the-art analytical
and manufacturing methodologies for proteins
- We have worked with proteins from a variety of expression
systems and with various posttranslational or chemical
modifications (PEGylation, Fc fusions, hyperglycosylation,
radiolabeling, enzymatic processing, etc)
Some examples of our protein development services
- Analytical, process and formulation development for protein
products
- Product characterization
- Analytical method development, validation and transfer
- Stability program development, implementation, and
statistical trending analysis
- Specification development
- Technical investigation of deviations, method failures,
and out-of-specification results
- Writing and review of CMC sections for global regulatory
submissions
- Development, oversight and review of comparability
protocols and assessments
- Reference standard program development and management
- Comprehensive and strategic coordination of all
CMC activities at contract service providers
Why choose RMC?
- Our cohesive CMC teams include technical experts, quality
assurance and integrated project management
- We bring experience with US, Canadian, European,
Japanese and other Asian regulatory regions
- RMC staff include recognized thought leaders in
the bio/pharmaceutical industry
- We have an in-house laboratory set up to accommodate
process, analytical and formulations development;
we can also manage activities carried out at other
contract labs
- RMC’s team approach provides you with seamless access
to a wide and deep knowledge base to tackle any
CMC issue, particularly for recombinant protein
and monoclonal antibody products
Benefits to outsourcing CMC support for protein or mAb
development
- Immediate access to technical and scientific experts,
with little to no learning curve required
- Flexibility to staff quickly without the commitment
of recruiting permanent hires
- Allows your internal staff to focus on other core
competencies or critical areas
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