What Is DANNALAB and What Testing Services Does It Provide?

Updated

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

Application area Techniques Typical questions answered
Small-molecule drugs XRPD Polymorph screening, crystallinity, identity, batch release and QC, method development and validation (ICH-compliant, LOD/LOQ stated at 0.17–0.5% wt)
Biopharmaceuticals and biosimilars SAXS Higher-order structure in native solution, comparability, aggregation and oligomerization, stability and forced degradation
Peptide CMC XRPD + SAXS/WAXS Aggregation and oligomerization, lipid-carrier structure, amorphicity and crystallinity of peptide API, polymorph and salt forms, structural comparability
Drug delivery systems SAXS LNP, liposome, and nanoemulsion structure; mRNA-LNP assembly; lipid phase and polymorph analysis
Nanoparticles SAXS Size distribution and internal structure
Pharmaceutical patents XRPD/SAXS data analysis Technical comparison of measured data against patent claims and specifications
Medical devices, structures, materials XRR and related X-ray methods Surfaces and coatings

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.