Capabilities
Our capabilities in dermatology span across research and development activities from inception to phase II supplies, with flexible approaches for both start-ups and big pharma.
At NUVISAN, we have access to extensive compound libraries and utilize high-throughput screening to support complete drug discovery. Further, we provide formulation development services including robust formulation selection processes. This approach relies on our experience of developing successfully marketed topical products. We also employ rational risk management to maximize potential for success in clinical studies.
With its integrated expertise in dermatology, NUVISAN employs a patient-centric approach wherein disease-adapted formulas are devised around the unique characteristics of each compound.
NUVISAN Drug Discovery Capabilities for Dermatology
NUVISAN drug discovery capabilities for dermatology cover all steps crucial to the creation of topically applied therapeutics. Starting in lead discovery, we identify HIT molecules using high-throughput screening (up to 150,000 compounds per day) and a wide array of biochemical and cellular assays as well as a solid biostatistical database.
At the hit-to-lead stage and during lead optimization, we support you with our panel of pre-clinical in vitro and in vivo tools for PK and tox evaluation and provide various efficacy models for inflammatory and non-inflammatory skin diseases (e.g., imiquimod-induced psoriasis in mice). Preliminary data on drug delivery into human skin and receptor fluid is gathered by in vitro permeation testing (IVPT) using human skin explants obtained from elective surgery. Thus, IVPT supports the selection of API candidates in early phase discovery and guides the choice of formulation and dosage for subsequent pre-clinical testing.
Our cross-functional collaboration of experts from DMPK and toxicology facilitates hit-to-lead conversion and lead optimization through appropriate in vitro assays and in vivo models for dermatological ADME and PK screening to enable preliminary prediction of safe and effective starting dosages.
NUVISAN Topical Drug Development Services for Dermatology (From Drug Substance to Drug Product)
Our drug development capabilities cover all steps required for conceiving and formulating dermatological therapeutics as well as conducting targeted clinical studies.
With expertise in formulation as well as chemical and analytical development, we offer you support in converting your API into a topically applicable drug product. As part of our chemical development expertise, we provide route scouting services and manufacturing of intermediate- (1–10 kg) and large-scale GMP-certified API batches for use in toxicological and clinical study settings.
At NUVISAN, close collaboration between chemical development and formulation science and technology enables thorough preformulation. This crucial activity includes the evaluation of polymorphism, salt screening, solubility, and compatibility as well as pH and oxidative sensitivity using a range of techniques including but not limited to XRPD, quantitative NMR, DSC, HPLC-UV, UPLC-UV, and RapidOxy. The obtained data provides an essential foundation for efficient, effective, and innovative formulation development.
Topical formulation development utilizes preformulation data and the target product profile (TPP) to initiate formulation design. We carry out diverse formulation screening and development of several concepts (within the TPP), determine chemical, physical, and microbiological stability, and evaluate skin permeability using IVPT. Simultaneously, we also characterize formulation microstructure, sensory properties, local tolerance data, and process to support and de-risk formulation selection. This rigorous technical approach enables the creation of effective, well-tolerated, and cosmetically elegant formulas by customizing formulation development to meet the needs of individual compounds, indications, patients, and clients.
The drug substance synthesized by the chemical development group is combined with the selected formula to make GMP-quality topical drug products, e.g., gels or creams, at the 10–50kg scale for regulatory toxicology and phase I and II clinical trials.
NUVISAN clinical trial supply services ship packaged and labeled drug products to clinical site(s) according to EMEA/FDA-conform clinical protocols.
Our research hospital in Neu-Ulm (Germany) regularly supports clinical examinations of topically applied therapeutics. Our team of experts has extensive experience in designing and conducting early clinical trials for various objectives. We conduct all types of phase I studies, including First-in-Man (FIM) studies, pharmacokinetic (PK) studies, safety studies, and pharmacodynamic (PD) studies in healthy subjects. We also have a proven track record of conducting complex studies, including those involving biologics, biosimilars, and novel modalities.
NUVISAN’s complementary, high-tech, and express approach involves close collaboration between formulators, chemists, analysts, and clinicians, thus shortening development times and ensuring your projects reach proof-of-concept studies faster.