Product Development and Manufacturing Core
GLP-Compliant Documentation
What is GLP?
Good Laboratory Practice (GLP) is a set of regulations (21 CFR 58), implemented by the FDA that focuses on the laboratory space and equipment, the personnel, and the study itself. It assures that data collected during an experiment is valid and correct and that the study can be performed again, exactly the same way.
Why is it needed?
GLP-compliance is required of all research and development that is intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration.
PDM Core Services
Service 1:
The creation and approval of GLP-compliant Standard Operating Procedure.
Service 2:
The creation and approval of Master Production and Control Records.
What do I need to do?
Please contact the PDM Core for specifics on the program and individualized service agreements.
E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu
Propagation
What is propagation?
The procedures used in the continuation and expansion of biologics
Why is it needed?
These procedures insure that eukaryotic, bacterial, viral, or other biological material are in sufficient quantity to perform all desired pharmaceutical processes, while maintaining stock for future use.
PDM Core Services
Service 1:
Propagation under BSL2 conditions
Service 2:
Propagation under BSL3 conditions
Service 3:
cGMP-compliant seed stock establishment
What is required?
A viable source of biological material from which propagation can occur.
What do I need to do?
Please contact the PDM Core for specifics on the program, material and shipping requirements, and individualized service agreements. E-mail inquires, questions, and orders to: Becky.Rivoire@colostate.edu
Optimization
What is optimization?
The streamlining of procedures and methods used in pharmaceutical processes.
Why is it needed?
Optimization can improve procedural success rates, increase product yields, decrease personnel requirements or reagent consumption, and increase cost efficiency.
PDM Core Services
Service 1:
Optimization of product
What is required?
Functional operational procedures that are in need of optimization.
What do I need to do?
Please contact the PDM Core for specifics on the program, technology transfer requirements, and individualized service agreements.
E-mail inquires, questions, and orders to: Becky.Rivoire@colostate.edu
Scale-Up
What is scale-up?
The refinement of protocols and procedures in an effort to increase product output.
Why is it needed?
Typical pharmaceutical scale-up will elicit 10x, 100x, or 1000x total product output from the original research protocols. This increase in yield will supply an appropriate amount of material for use during manufacturing.
PDM Core Services
Service 1:
Scale-up of product
What is required?
Transfer of existing protocols and procedures so that they can be refined.
What do I need to do?
Please contact the PDM Core for specifics on the program, technology transfer requirements, and individualized service agreements.
E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu
Preliminary Characterization/Formulation
What is characterization/formulaton?
Pre-formulation processing includes physical and physcio-chemical properties of bulk active ingredient and major excipients. The basic principles and problems of formulation of pharmaceutical, vaccine and diagnostic products will be coordinated by the Translational Development Subcommittee and addressed by the PDM Core ProductDevelopment Manager via FDA and ICH Guidance documents, and interaction/outsourcing with Formulation Experts, as needed.
Product characterization includes developing an aggregate of methods to describe the character or quality of an intermediate or final product. PDM Core personnel will consult FDA and ICH Guidance documents, pharmaceutical and/or biotechnology company contacts, and regulatory consultants to meet quality standards outlined in the cGMP regulations.
PDM Core Services
Service 1:
Characterization of master seed stock
Service 2:
Characterization of product
Service 3:
Development of formulation strategies
What do I need to do?
Please contact the PDM Core for specifics on the program, material and shipping requirements, and individualized service agreements.
E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu
Purification
What is purification?
The process of selectively removing impurities, intermediate forms of the final product, byproducts, or any other substances other than the desired chemical or biologic.
Why is it needed?
Purification may decrease the potential for introduction of contaminating substances or biologics into downstream procedures or final products.
PDM Core Services
Service 1:
Purification of product
What is required?
Bulk biologic, raw chemical, or intermediary product where contaminates, if present, would significantly alter the integrity, safety, identity, stability, sterility, or potency of the final product.
What do I need to do?
Please contact the PDM Core for specifics on the program, technology transfer requirements, and individualized service agreements.
E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu
Assay Development
What is assay development?
The development of defined and controlled procedures used during the manufacturing and testing of in-process and final products.
Why is it needed?
Assay development will ensure that in-process and final products are produced per FDA regulations; that they are made with the highest quality materials and appropriate methods; that all procedures are reproducible and that all products are traceable; and that all products are tested appropriately for integrity, safety, identity, stability, sterility, and potency.
PDM Core Services
Service 1:
Development of control assays
Service 2:
Development of manufacturing assays
Service 3:
Performing of stabilization assays
What do I need to do?
Please contact the PDM Core for specifics on the program, technology transfer requirements, and individualized service agreements.
E-mail inquires, questions, and orders to: Becky.Rivoire@colostate.edu