Identity
Verification of the defined D016 protein material according to the applicable technical specification.
D016 SCIENCE & EVIDENCE
From biotechnology to documented cosmetic evidence.
Characterization · Analytical Quality · Formulation Development · Stability · Product-Specific Evidence
D016 is a recombinantly produced hyaluronidase developed for integration into defined topical cosmetic formulation concepts.
RECELURA assigns technical characterization, formulation development and product-specific evidence to the level for which the respective data were actually generated.
Properties of D016 as an ingredient are not automatically transferred to a finished cosmetic product. Safety, stability, intended cosmetic use and claims are assessed at the level of the respective finished formulation.
COSMETIC SCOPEThis page is limited exclusively to D016 in the context of topical cosmetic formulations and finished cosmetic products. No medical, therapeutic or medical-device intended purpose is claimed on this page.
D016SCIENCE & EVIDENCE
IDCHARACTERIZATION
ACTACTIVITY
FORMFORMULATION
EVIDEVIDENCE
SCIENTIFIC & TECHNICAL IDENTITY
Recombinantly produced hyaluronidase for topical cosmetic formulation concepts.
D016 is a recombinantly produced hyaluronidase manufactured through a defined biotechnological process.
For cosmetic applications, D016 is considered as an ingredient within separately developed topical formulation systems.
Technical ingredient properties, analytical characterization and batch-related quality data form a distinct evidence level.
Assessment of a finished cosmetic product is performed separately on the basis of its complete formulation and expressly defined intended cosmetic use.
TECHNICAL CHARACTERIZATION
Measurable quality attributes rather than transferred assumptions.
Purity
Assessment of protein purity and relevant process-related quality attributes using appropriate analytical methods.
Enzymatic Activity
Batch-related determination of hyaluronidase activity using a defined analytical method and documented acceptance criteria.
Physicochemical & Microbiological Attributes
Assessment of relevant parameters according to supply format, development stage and intended cosmetic project.
ANALYTICAL QUALITY
Evidence begins with defined measurement and documented criteria.
Scientific and technical evaluation requires defined specifications, suitable analytical methods and traceable acceptance criteria.
RECELURA therefore separates the technical characterization of D016 from statements concerning the performance of a finished cosmetic product.
Batch-related quality information is documented according to the respective development and supply purpose and evaluated against the specifications defined for that purpose.
Technical documentation may include, where applicable, CoA, TDS, SDS, specifications and batch-related quality information.
FORMULATION DEVELOPMENT
The ingredient is not the finished cosmetic product.
Technical properties of D016 as an ingredient do not automatically constitute properties, safety conclusions or cosmetic claims of a finished formulation.
Gel and cream formulations are developed as complete topical cosmetic systems in which composition, compatibility, stability and intended cosmetic use are considered together.
Formulation development connects the defined ingredient with the requirements of the specific cosmetic product concept.
This separation allows different cosmetic formulation concepts without transferring claims or regulatory conclusions from one product to another.
D016INGREDIENT
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FORMFORMULATION
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STABSTABILITY & COMPATIBILITY
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PRODUCTFINISHED COSMETIC PRODUCT
STABILITY & COMPATIBILITY
Evidence applies to the material or formulation that was actually evaluated.
Stability and compatibility are assessed at the level relevant to the respective material or cosmetic formulation.
Evaluation may include appearance, formulation integrity, relevant physicochemical parameters and preservation of defined quality attributes.
For D016-containing formulations, compatibility of the ingredient with the respective cosmetic formulation environment is considered on a project-specific basis.
Stability conclusions are made only for the formulation actually evaluated and the period investigated and are not automatically transferred to other cosmetic products.
PRODUCT-SPECIFIC EVIDENCE
Cosmetic claims follow the finished product that was evaluated.
Safety Assessment
Product-specific cosmetic safety documentation based on the complete formulation and intended cosmetic use.
Dermatological Compatibility Testing
Product-specific testing within a cosmetic context where intended and available for the respective topical cosmetic application.
Measurement & Documentation
Defined instrumental or standardized documentation procedures where used for the respective cosmetic product concept.
Claim Substantiation
Cosmetic claims are used only to the extent supported by evidence relating to the respective finished product.
D016 EVIDENCE FRAMEWORK
Evidence is generated and interpreted at the level to which it actually applies.
01BIOTECHNOLOGY
02INGREDIENT CHARACTERIZATION
03ANALYTICAL QUALITY
04TOPICAL FORMULATION DEVELOPMENT
05STABILITY & COMPATIBILITY
06FINISHED COSMETIC PRODUCT ASSESSMENT
07PRODUCT-SPECIFIC CLAIM SUBSTANTIATION
PUBLIC TECHNICAL CONTEXT
D016 has a technical context beyond the RECELURA cosmetic platform.
Publicly available patent literature provides technical background on D016 and related hyaluronidase technology. RECELURA does not use this technical context as a substitute for product-specific assessment of finished cosmetic products.
RECELURA communication on this website remains limited to topical cosmetic applications of D016, cosmetic formulation development, quality and product-specific evidence.
Broader technology, intellectual-property and non-cosmetic development activities are managed separately from the RECELURA cosmetic platform.
D016 TECHNOLOGY & IP · PHARMACT HOLDING AG →D016 SCIENCE & EVIDENCE