Peptides and proteins are gaining ground as active substances in biopesticides. They offer a biological alternative to conventional chemistry, but bringing them to market is harder than the science alone suggests. Regulators expect you to prove what your active substance is and that every batch is the same. For a complex, naturally derived substance, that is not straightforward.
Triskelion helps you characterise peptide and protein-based active substances and demonstrate batch-to-batch consistency with defensible analytical evidence, so your dossier holds up where it matters.
We help you define identity, demonstrate batch equivalence and document it in a way that supports your dossier. Contact Isabel van Laanen for an intake or a characterisation strategy tailored to your substance.
A peptide or protein-based active substance is rarely a single, clean molecule. Most are natural complex substances with a variable or partly unknown composition. That creates a challenging issue under EU plant protection regulation. You are required to define the identity of your active substance and to show that production batches are equivalent, but standard targeted analysis is built around known, individual compounds. It does therefore not capture the full pattern of a complex mixture.
The guidance points towards the use of chemical fingerprinting as the way to characterise these substances and assess similarity between batches. What it does not do is explain how that fingerprinting could be performed. That gap might leave applicants ‘exposed’: the expectation is clear, but the method isn’t. Submitting a dossier without a robust, reproducible characterisation approach is where delays and questions from the rapporteur member state begin.
Under Regulation (EC) No 1107/2009, an active substance must be defined and its specification supported before a plant protection product can be authorised in the EU. For active substances this includes establishing identity and demonstrating that the material produced across batches is sufficiently equivalent, commonly addressed through five-batch analysis.
For natural complex substances, the dossier expectation is more demanding than for a single synthetic molecule. Authorities expect you to justify the identity of the substance, account for components that may be of concern for humans or the environment, and demonstrate similarity across batches. Because relevant information may already exist from other regulatory areas such as food, medicine or biocides, a tailor-made registration strategy is advised, ideally discussed with the rapporteur member state in a pre-submission meeting before data is generated.
This matters when you are developing a peptide or protein-based biopesticide and need to define the active substance for a dossier, when you must demonstrate batch equivalence through five-batch analysis, when your substance is a natural complex mixture without a clear single-component specification, when targeted methods cannot fully describe what your material contains, or when you are preparing for a pre-submission meeting and need a characterisation strategy you can defend.
In each case the underlying question is the same: can you show, with evidence, that your active substance is what you say it is and that it does not change from batch to batch.
Triskelion developed the molecular barcode, a fingerprinting approach based on non-targeted LC-MS, specifically to characterise natural complex substances where targeted analysis falls short. It provides an initial overview of the identity of a complex substance and serves as a tool to assess the similarity of natural mixtures, which makes it suitable for five-batch analysis.
The value is not only in generating the profile but in interpreting it. Our experts combine high-resolution analytical data with chemometric assessment and regulatory understanding, so the result supports your dossier rather than simply adding data to it.
We help you build a registration strategy based on what is already known about your substance, characterise the active substance, and document equivalence in a form that withstands regulatory scrutiny. Where useful, we can support the dialogue with authorities, including preparation for pre-submission discussions.
The molecular barcode is based on non-targeted LC-MS, capturing the broad chemical profile of a complex substance rather than a set of predefined analytes. It is applied to establish an identity overview of natural complex substances and to assess similarity between batches for equivalence purposes. Interpretation uses chemometric and statistical evaluation by experienced scientists, delivered as clear, audit-ready reporting suited to regulatory submission. The approach is tailored to the substance and the regulatory context rather than applied as a fixed protocol.
Not for complex substances. Targeted methods measure known individual compounds. A peptide or protein-based active derived from a natural source needs an approach that captures the full pattern, which is what non-targeted fingerprinting provides.
Yes. It is a suitable tool for assessing the similarity of natural complex mixtures, which is exactly what batch equivalence requires.
As early as possible. A characterisation and registration strategy is best defined before generating data and ideally discussed with the rapporteur member state in a pre-submission meeting, so the approach is agreed rather than questioned later.
We help you define identity, demonstrate batch equivalence and document it in a way that supports your dossier. Contact Isabel van Laanen for an intake or a characterisation strategy tailored to your substance.
