InterBioTox

Toxicology Consulting

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We provide global and robust expert toxicology consulting services to pharmaceutical, biotechnology and medical device companies and their products.


Our Toxicology Consulting Services includes:





​​Toxicological Risk Assessments (TRA)

The relationship between a hazard and potential for exposure defines risk. Toxicological risk assessments determine whether or not a product poses a potential risk for the toxicological endpoints measured and, if desired, can be amended to also include suggested labelling phrases, warnings and warning symbols that may be necessary on the package of the product.

Our Toxicology Risk Assessment (TRA) Services include:


● Evaluation of the toxicity of the individual chemical ingredients of the     formulation used to manufacture the product:

      ► Each ingredient is assessed for its hazard or "inherent" toxicity such as             acute toxicity, skin/eye irritancy, potential for skin sensitization,             reproductive, genotoxic, or carcinogenic activity, in relation to the             potential for consumer exposure to the chemical


● Exposure considerations:

       ►characteristics of the product such as physical form and size/volume

       ► accessibility (e.g. liquid components)

       ► intended use


● Consideration of potential for misuse of the product


● European Toy Regulations


● European Cosmetic Regulations


● Canada Hazardous Products (Toys) Regulations


● CPSC Regulations


● Establishing Health-Based Exposure Limits for APIs in the EU
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​​Scientific and medical writing services

Our medical and pharmaceutical experts have diverse scientific knowledge and extensive experience of pharmaceutical development to produce clear and concisely worded documents for medical and pharmaceutical companies worldwide. Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of medical and pharmaceutical documentation to address the needs of various stakeholders, medical monitors, study coordinators and regulatory reviewers.

We can assist your company with all nonclinical and clinical Associated Regulatory Tasks including:

    ● Product Monographs, Package Inserts, etc.

    ● Preparation of nonclinical and clinical sections for CTD Module 2


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​​Establishing Health-Based Exposure Limits

Our specialists are well-positioned to perform assessments and prepare reports that are compliant with the EMA guidelines.


The evaluation of risks related to the carryover contamination of one or more drugs into another during manufacturing is the focus of the European Medicines Agency (EMA) guideline “Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.  In effect since June 1, 2015, the recommendations in this guideline have impact on the manufacture of multiple medicinal products in shared facilities.  This guideline outlines requirements and methods for establishing health-based exposure limits that are to be used when evaluating risks related to the possibility of carryover contamination, with the aim of addressing the safety of human, and animal, patients potentially exposed to residual active substances via medicinal products.  Manufacturers and drug companies need to adhere to the guideline to address potential cross-contamination of active pharmaceutical ingredients (APIs, or drug substances) for products to be marketed in Europe.  Similar guidelines specific to other regulatory jurisdictions have not been released to date.


The health-based exposure limit for a given API is the permitted daily exposure (PDE) value (also known as the allowable daily exposure, or ADE). Derivation of a PDE value requires examination and interpretation of toxicology/safety data, pharmacology (efficacy) data, information on the route of administration, and other considerations.  The PDE value is used to help establish cleaning validation requirements in manufacturing facilities (e.g., maximum allowable carryover values, or MACO values) and to assist with decisions regarding the use of dedicated equipment or facilities for certain APIs.


Drug companies and contract development and manufacturing organizations (CDMOs) need to be aware of the guideline’s expectations regarding data collection and assessment, methods used to derive PDE values, and reporting requirements.   



Our assurance team can:


        ● Calculate the PDE of your API based on a review and assessment of relevant toxicological and pharmacological data

        ● Perform assessments and prepare reports that are compliant with the EMA guideline

        ● Work with clients to prepare tailored assessment reports for proprietary and generic drug substances/products that address 

            the requirements of the EMA guideline.

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Extractables and Leachables Studies

Extractables and leachables (E/L) studies are critical to the identification and quantification of harmful leachable impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products.


A profile of extractable components must be obtained, via controlled extractables studies (CES), in order to identify potential sources of leachables such as antioxidants, plasticizers, dyes and metal catalysts. As pharmaceutical packaging, drug delivery systems and implantable medical devices can be extremely complex, with mixtures of plastic, polymer, rubber or glass materials, printed surfaces and coatings all utilized, it is critical that E/L studies are designed specifically for your drug product and the container materials so that the risks associated with leachable impurities can be assessed.


Our scientists conduct extractables and leachables studies in accordance with regional guidance, Good Manufacturing Practice (GMP) PQRI recommendation, United States Pharmacopeia (USP) requirements (including USP chapters <1663>, <1664>, and <1664.1>), and awareness of FDA guidelines. As an initial step, we aim to gather all information about your packaging system in order to obtain a strong impression of potential sources of extractables or leachables. The combination of our experience in method development for controlled extractables studies, coupled with our vast knowledge of leachable compounds, mean that we can anticipate and identify potential sources of risk through strategic screening studies.


We provide leachables method validation compliant to Good Manufacturing Practice (GMP) for use in storage and stability programs  and can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, orally inhaled and nasal drug products (OINDP), single use and disposable medical equipment, printed packaging and bioprocessing equipment. Leachables associated with drug delivery systems, implantable medical devices and other devices such as e-cigarettes are also assessed. 


Our analytical teams can determine both organic and inorganic contaminants through the application of  a range of instrumentation including liquid chromatography (HPLC) liquid chromatography-mass spectrometry (LC-MS(MS)), gas chromatography (GC), gas chromatography-mass spectrometry (GC-MS(MS)), and inductively coupled plasma spectroscopy (ICP, ICP-MS), dependent on the analysis. 


Comprehensive evaluation and safety assessment review of laboratory E/L study data is performed by our in-house toxicologist consultants in order to identify and address potential risks and to assist with comprehensive impurity testing, whilst identifying any gaps in your existing data packages. We also provide recommendations and support for preparation of very low-risk data packages related to E/L testing.
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InterBioTox

Rybne namestie 1 

811 02 Bratislava,

Slovakia 


+421 911 505 857

info@interbiotox.com




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