dannalab.com

DANNALAB is a contract testing laboratory specializing in cGMP-compliant X-ray powder diffraction (XRPD) and small-angle X-ray scattering (SAXS) for pharmaceutical and biopharmaceutical CMC work. It fits teams that need regulatory-ready XRPD or SAXS data for method development, batch release, stability studies, or patent analysis, and it advertises QA-approved certificates of analysis with 24–48 hour turnaround available. If your need is routine wet-chemistry testing or clinical trial services, this is not the right kind of lab.

What DANNALAB actually does

The lab's scope is narrow by design: two X-ray characterization techniques applied across drug substance, drug product, and delivery systems.

• XRPD covers solid-state questions — polymorphism, crystallinity, and identity of APIs and formulations.
• SAXS covers structure in solution and in carriers — proteins, peptides, antibodies, liposomes, lipid nanoparticles, and nanoemulsions.

Both are offered with cGMP documentation. The site states the lab has been cGMP accredited since 2014, works to USP <941> and Ph. Eur. <2.9.33>, and supports 21 CFR Part 11 with traceable data.

Services by application area

What the documentation and turnaround mean in practice

For a release or stability package, the practical value is in what arrives with the data: a QA-approved CoA and documentation structured for regulatory submission. The stated 24–48 hour turnaround is described as an option, so treat it as something to confirm for your specific method rather than a default for every project.

One regulatory point the site raises that matters for EU-facing clients: pharmaceuticals imported into the EU require GMP testing in an EU laboratory under Directive 2001/83/EC. If your supply chain touches the EU, check whether that requirement applies to your product and confirm with the lab how it is handled.

How to decide whether to use it

DANNALAB is a reasonable fit if all of the following hold:

• Your analytical question is solid-state or nanostructure characterization that XRPD or SAXS can answer.
• You need the output to stand up in a regulatory filing, a batch release package, or a patent dispute.
• You want a specialist lab rather than a full-service CRO.

Look elsewhere if you need broad analytical chemistry, bioanalytical assays, or clinical services. The site does not publish pricing; it directs inquiries to a technical quote or price list request, so cost and scheduling have to come from that conversation. Before committing, ask for the validation package for your specific method, confirm the turnaround in writing, and clarify the EU import testing position if it applies to you.

Choose XRPD when your question is about the solid state — polymorphism, crystallinity, identity, or salt form of an API or formulation. Choose SAXS when your question is about structure in solution or in dispersion — proteins, peptides, antibodies, liposomes, LNPs, nanoemulsions, or nanoparticles. If your sample is a lipid carrier or a peptide system where both solid-state form and solution structure matter, DANNALAB offers combined SAXS/WAXS characterization. Both techniques are run under cGMP with regulatory-ready documentation.

The deciding question: solid state or solution structure?

DANNALAB's service pages split along one practical line: whether the property you need to demonstrate lives in the crystal lattice or in the arrangement of molecules in a liquid or dispersed phase.

When XRPD is the right choice

XRPD is DANNALAB's small-molecule workhorse. The site lists it for polymorphism, crystallinity, and identity of APIs and formulations, and positions it inside release packages with QA-approved CoA and 24–48 hour turnaround available.

Use XRPD if you are:

• Releasing batches or running QC. XRPD fits release packages where the solid form must be confirmed against specification.
• Developing or validating a method. DANNALAB describes ICH-compliant validation with LOD/LOQ determination in the 0.17–0.5% wt range and rapid feasibility assessment.
• Supporting identification and quantification. Both are listed XRPD applications for small-molecule drugs.
• Handling EU import testing. Pharmaceuticals imported into the EU require GMP testing in an EU laboratory under Directive 2001/83/EC; XRPD release testing is one of the services DANNALAB maps to that requirement.
• Working on peptide solids. For peptides, XRPD covers amorphicity, crystallinity, polymorph and salt-form characterization, and CMC structural comparability.

A practical example: you have a generic solid oral product and need to show the API is present in the same polymorph as the reference, plus confirm crystallinity has not changed after stability storage. That is an XRPD question end to end.

When SAXS is the right choice

SAXS answers questions XRPD cannot: how molecules are arranged in native solution or inside a dispersed particle. DANNALAB lists SAXS for:

• Biopharmaceuticals and biosimilars — higher-order structure in native solution, comparability studies, aggregation and oligomerisation detection, and stability or forced-degradation studies.
• Drug delivery systems — LNP, liposome, and nanoemulsion structure; mRNA-LNP assembly characterization; lipid phase and polymorph analysis. cGMP documentation is available for selected methods.
• Nanoparticles — size distribution and inner structure.
• Peptides in solution — aggregation, higher-order structure, oligomerisation and stability monitoring, and lipid-carrier characterization when combined with WAXS.

A practical example: you are developing an mRNA-LNP and need evidence that the lipid carrier's internal structure is consistent between batches, or that it survives a stress condition. That is a SAXS question.

When you need both

Two application areas on DANNALAB's site explicitly combine the techniques:

• Peptide CMC. Solution-state work uses SAXS (with WAXS for lipid carriers), while solid-state work uses XRPD for amorphicity, crystallinity, and polymorph/salt form. A full peptide CMC comparability package can draw on both.
• Lipid-based carriers. SAXS gives the mesophase structure; WAXS resolves the sharper-length-scale lipid phase and polymorph information.

If your program spans drug substance solid form and a formulated carrier, plan the combined approach up front rather than sequencing two separate studies.

A third case: patents and specifications

DANNALAB also offers technical analysis of XRPD and SAXS data against patent claims and specifications. The technique follows the claim: if a patent asserts a polymorph, the analysis is XRPD-based; if it asserts solution structure or particle characteristics, it is SAXS-based. Decide the technique from the claim language, not the other way around.

What applies regardless of technique

DANNALAB states cGMP accreditation since 2014, alignment with USP <941> and Ph.Eur <2.9.33>, 21 CFR Part 11 compliance, traceable data, QA-approved CoA, and 24–48 hour turnaround available. These are the documentation and timeline conditions to confirm for your specific method when you request a technical quote or price list — the site does not publish pricing, so scope and cost come through that request rather than from a public rate card.

Quick decision rule

• Solid, crystalline, or polymorph question → XRPD.
• Solution, dispersion, particle, or aggregation question → SAXS.
• Peptide or lipid system where both matter → combined SAXS/WAXS plus XRPD.
• Patent or specification comparison → match the technique to what the claim describes.

Yes. DANNALAB is built around exactly these three use cases: cGMP-compliant XRPD and SAXS testing for pharmaceutical CMC, with QA-approved CoAs for batch release, ICH-compliant method validation for stability and forced-degradation work, and technical comparison of XRPD/SAXS data against patent claims and specifications. Turnaround as fast as 24–48 hours is listed as available for time-sensitive projects. The main condition to check before committing is fit: which technique (XRPD vs. SAXS) matches your sample type, and whether your specific method falls under the cGMP documentation scope offered.

Batch Release and Quality Control

XRPD is positioned as part of release packages for small-molecule drugs, covering polymorphism, crystallinity, and identity of APIs and formulations. The relevant commitments from the site:

• QA-approved CoA issued with results, described as batch-release ready.
• cGMP accredited since 2014, with USP <941>, Ph.Eur <2.9.33>, and 21 CFR Part 11 traceable data cited as the operating framework.
• 24–48 hour turnaround available — useful when a release decision is holding up a shipment or a deviation investigation.

One practical constraint worth knowing: pharmaceuticals imported into the EU require GMP testing in an EU laboratory under Directive 2001/83/EC. If your batch release depends on EU import testing, confirm with DANNALAB that the specific test and documentation meet that requirement before you plan around it.

Stability Studies and Method Validation

For stability and forced-degradation work, the site lists:

• Stability and forced-degradation studies under the SAXS/biopharmaceuticals offering, including aggregation and oligomerisation detection — relevant for proteins, peptides, and antibodies in native solution.
• ICH-compliant method validation with LOD/LOQ determination in the 0.17–0.5% wt range for XRPD, plus rapid feasibility assessment.

The LOD/LOQ figures matter for a concrete reason: if you need to detect a low-level polymorphic impurity or a small crystalline fraction in a mostly amorphous formulation, a limit of detection around 0.17–0.5% wt sets the floor on what a stability trend can actually show. If your specification sits below that range, raise it early — method development may be needed rather than a standard validated method.

Choosing the right technique before you brief the lab

Getting this wrong is the most common way a quote cycle stalls, so state your sample matrix and the decision the data must support in your first inquiry.

Patent Analysis

DANNALAB offers technical analysis of XRPD and SAXS data against patent claims and specifications. In practice this means you bring the patent language and the measured pattern or scattering profile, and the comparison is documented technically. Two things to settle up front:

1. Scope — confirm whether you need a comparison report or something intended to support a formal opinion; the site describes technical analysis, not legal advice.
2. Data provenance — for a comparison to hold up, the underlying measurement should come from a validated method with traceable data (21 CFR Part 11 is cited). If you are comparing against someone else's published pattern, say so, because instrument and sample-prep differences affect peak positions and intensities.

What to Confirm Before You Commit

• Turnaround: 24–48 hours is described as available, not standard — confirm the timeline for your specific assay when requesting a quote.
• Pricing: the site invites a "Technical Quote or Price List" request but publishes no rates, so budget only after you have the quote in hand.
• Method coverage: cGMP documentation is noted as available for selected SAXS methods (drug delivery systems), so verify your method is in scope if you need a regulated submission package.
• Sample type fit: peptide work spans both solid-state (XRPD) and solution-state (SAXS), so specify which you need.

The fastest path is to request a technical quote with your sample type, the CMC stage (release, stability, or patent comparison), and your deadline — that lets DANNALAB confirm technique, documentation level, and whether the 24–48 hour window applies to your assay.

DANNALAB provides cGMP-compliant XRPD and SAXS testing with regulatory-ready documentation, including QA-approved Certificates of Analysis (CoA), traceable data, and batch-release-ready packages. The lab states it has been cGMP accredited since 2014 and works to USP <941>, Ph.Eur <2.9.33>, and 21 CFR Part 11. This makes it a candidate testing partner if you need X-ray characterization data that can be filed in a regulatory submission or used in a release decision. The fit depends on your method type, whether the specific method is validated, and whether your product falls under EU import testing rules.

Compliance Framework You Can Cite

DANNALAB's stated compliance basis covers three areas that matter in a submission:

These are the lab's own stated credentials. Before you rely on them in a filing, confirm the current scope of accreditation and request the quality documents your submission requires (for example, a quality manual excerpt or audit statement).

Documentation You Receive

The output documentation is where most of the regulatory value sits:

• QA-approved CoA. Issued for batch release and quality control work, so the certificate can go into a release package rather than being re-issued internally.
• Batch-release-ready packages. XRPD results can be built into release testing, with CoA issued and turnaround stated as 24–48 hours where available.
• Method development and validation records. ICH-compliant validation with LOD/LOQ determination stated at 0.17–0.5% wt, which is the kind of sensitivity data a specification justification needs.
• Traceable raw data. Underpins 21 CFR Part 11 compliance and lets you answer questions about how a result was generated.

A practical check: ask for a sample CoA and a validation summary before contracting. The CoA format and the level of method detail are what a reviewer will actually see.

Where the Documentation Fits in a Submission

The services map onto common CMC sections:

• Solid-state characterization of small-molecule APIs and formulations — polymorphism, crystallinity, and identity by XRPD, usable for specification setting and stability sections.
• Biopharmaceutical higher-order structure — SAXS in native solution for proteins, peptides, and antibodies, including biosimilar comparability and aggregation detection.
• Drug delivery systems — LNP, liposome, and nanoemulsion structure, with cGMP documentation stated as available for selected methods.
• Patent analysis — technical comparison of XRPD/SAXS data against patent claims and specifications.

Note the qualifier on drug delivery: documentation is available for selected methods, so confirm coverage for your specific carrier system before assuming a cGMP package.

EU Import Testing: A Separate Requirement to Check

If you import pharmaceuticals into the EU, GMP testing must be performed in an EU laboratory under Directive 2001/83/EC. DANNALAB lists EU import testing as an application area. If your product is destined for the EU market, verify that the specific testing you need satisfies the EU-lab requirement, since this is a location-based rule, not only a documentation one.

Conditions Before You Commit

Use DANNALAB when you need XRPD or SAXS data with a QA-approved CoA and a compliance trail that references recognized compendial methods. Confirm these points first:

1. The accreditation scope covers your specific method and product type.
2. Validation data (including LOD/LOQ) exist for your method, not only for the platform.
3. The CoA and data package match your submission format and audit needs.
4. For EU-bound products, the EU-lab testing requirement is met.
5. Turnaround commitments (24–48 hours where available) fit your release timeline.

Pricing and access terms are not stated on the page, so request a technical quote or price list to confirm commercial conditions.

DANNALAB does not publish pricing on its website. To get numbers, you go through its quote process: the site's primary call to action is "Request a Technical Quote or Price List," and scope, technique, and turnaround are confirmed as part of that request rather than from a public rate card. Before you submit, gather four things — sample type, technique (XRPD or SAXS), application area, and timeline — because those are the variables that determine what the lab quotes.

What the site actually offers

The homepage presents two entry points side by side: a Technical Quote and a Price List. Both are requests, not self-serve downloads, so expect to describe your work before receiving either.

The services you can request a quote for are organized by application area:

Information to prepare before you ask

A quote is only as precise as the brief behind it. Have these ready:

• Sample type and matrix — API, formulation, peptide, protein/antibody, LNP or liposome, nanoparticle, or device surface. This alone narrows the technique.
• Technique — XRPD for crystalline/amorphous solid-state questions; SAXS for solution structure, aggregation, and carrier morphology. If you are unsure, say so and describe the question instead; the lab can advise.
• Application area and purpose — development, batch release, stability study, comparability, or patent analysis. Purpose drives documentation requirements.
• Timeline — the site advertises 24–48 h turnaround available, so state your deadline explicitly if you need that window.
• Documentation needs — whether you need a QA-approved CoA, method validation to ICH, or data suitable for a regulatory submission.

What to expect back

The site states that testing is cGMP-compliant, accredited since 2014, aligned with USP <941> and Ph.Eur <2.9.33>, and 21 CFR Part 11 with traceable data. Those claims matter for the quote because they define what documentation is included — for example, a batch-release package with a QA-approved CoA versus a development-stage characterization report. Ask in your request which of these is covered for your specific method, since the site notes cGMP documentation is available "for selected methods" in the drug-delivery area.

For EU-bound products, note the site's point that pharmaceuticals imported into the EU require GMP testing in an EU laboratory under Directive 2001/83/EC — worth confirming against your own supply chain when you scope the work.

Common sticking points

• No public price list to browse. Treat "Price List" as a request, not a page you can read. If budget approval needs a range first, ask for indicative pricing by technique and sample count.
• Vague sample descriptions slow things down. "Protein sample" is not enough for SAXS scoping; specify whether it is in native solution, what formulation, and what question you are answering.
• Turnaround is "available," not default. The 24–48 h figure is an option to request, so confirm it in writing for your batch.
• Validation scope varies. Method development and validation with LOD/LOQ determination (0.17–0.5% wt) is described for XRPD; confirm whether your specific assay needs full ICH validation or a feasibility assessment first.

Practical next step

Submit the quote request with a one-page brief covering the five items above, and ask two direct questions: which documentation tier applies to your method, and whether your target turnaround is achievable for your sample count. That turns the request into a scoped proposal you can compare and approve.