Sujata Syam has been leading a group of scientists in building CPL’s newest service offering—testing of topical pharmaceutical products using skin-based technologies and approaches. Sujata joined CPL in 2015 to head up the Skin Lab within the Product Development Services group. Sujata has more than 20 years of experience in proteins, assay development and therapeutics.
Q: Why is CPL launching this new testing service?
CPL has been a leading provider of pharmaceutical product development and commercial manufacturing services focused on non-sterile liquid and semi-solid dosage forms for many years. We’ve seen a growing number of customers with topical product programs (gels, ointments, creams, lotions) that require in-vitro skin testing to support FDA guidelines for the development of such products. We created our skin testing lab to respond to these needs in conjunction with our world-class product development services, all under one roof.
Q: What services are currently provided in the skin lab?
We offer three types of skin testing services to our customers, including:
In vitro release testing (IVRT): We conduct GMP IVRT testing using a dry-heat Logan Franz cell system certified for GMP work located in a GMP-certified environment. We offer method development and validation services for any given drug. We conduct testing to support formulation development and to monitor batches through scale-up from lab batch to manufacture. We offer IVRT services to support shelf-life stability, lot variability and site-transfer studies. We also conduct comparative testing of generic formulations with Reference Listed Drug to establish bioequivalence in accordance with Mann-Whitney Rank Sum Test. The lab provides detailed documentation for submission to regulatory agencies.
Mass Balance Distribution Analysis: We use excised animal skin discs to study drug distribution in the receiving medium, within the skin and on top of the skin (‘left over’) fractions. We offer this testing to support formulation development, drug screening and penetration and bioequivalence studies.
In vitro penetration testing (IVPT): IVPT is a critical tool for understanding drug delivery into various layers of skin and helps identify formulations delivering the drug to the target skin layer. The drug is applied on pig skin discs and partitioning across different skin layers is determined by tape striping. Our services include method development and drug distribution analysis. We offer IVPT services to support formulation development and bioequivalence testing.
Q: What skin models are you working on?
We have successfully built a human cell-line-based normal skin model. A cross-section of this 3D model reveals all distinct layers, each with its characteristic features. We are in the process of inducing psoriatic phenotype in this model. We look forward to replicating this model with human primary cells and to generate additional phenotypes
Q: What cell-based testing is offered in the lab?
Currently we offer gene-regulation testing on fibroblast and keratinocyte mono-layers. We offer both method development and drug testing. Method development includes optimizing dosage and dosing schedule, marker panel selection, drug screening and gene and protein profiling in response to drugs.