CARMELL THERAPEUTICS
At Carmell Therapeutics, a collaborative team works together to develop and analyze a novel plasma-based bone putty called Bone Healing Accelerant (BHA) with applications in severe bone trauma.
Bone Healing Accelerant Product Method Development and Validation
Credit: Carmell Therapeutics
COMPANY STANDING AND PROGRESS IN R&D AT INITIATION OF INTERNSHIP
Pre-Clinical and Phase II Clinical Trial Completion
Characterization Test Method Development/
Validations
Stability Study Execution and cGMP Batching
Phase III IND Submission and Approval
In June 2018, there was a need for development of characterization methods (both biological and physical), as well as validation and implementation of these methods as they deem pertinent to stability studies and GMP batching for work towards a Phase III Clinical Trial IND submission.
Below depicts each field of R&D that I actively contributed to over the course of my co-op internship and the skills gained from these experiences.
Development
Development of product characterization and release test methods
-
Growth factor identification and quantification via bead-based fluorescent Luminex technologies and absorance-based ELISAs (TGF-beta, PDGF-AB/BB, EGF, IGF)
-
Total Protein Quantification via Pierce Peptide Assays
-
Content Uniformity via solubilization and filtering methods (tri-calcium phosphate quantification)
collaborative validation
Conceptualization and lead-operator of full validation of both biological and physical characterization assays/methods
Responsible in training new hires on test methods and analysis
method implementation
Technical writing
Authored and executed validation and comparability protocols.
Authored subsequent technical reports and led data presentations to C-level executives
method implementation
Performed stability and cGMP testing and documentation
Contributed to out-of-specification investigations
CONCLUSION
Pre-Clinical and Phase II Clinical Trial Completion
Characterization Test Method Development/
Validations
Stability Study Execution and cGMP Batching
Phase III IND Submission and Approval
At Carmell, I was able to expand my problem-solving skills, work in an ever-growing collaborative environment, and enhance my technical laboratory skills with a focus in GMP methodologies.
I wish the Carmell Team all the best as they continue their clinical trial endeavors, hoping to provide patients with a method of bone healing through natural, regenerative factors!