Services · Analytical Services
Is your own laboratory at capacity, or is a required method unavailable or not yet established? Then not only the test result is delayed, batch release can stall too. A&O Pharma takes on your analytical samples in our GMP-certified laboratory. Thanks to end-to-end digitalisation, we process your orders efficiently, transparently and traceably, for reliable results and short turnaround times.
Non-binding and confidential. Answer in one to two working days.
Robust analytical results are the foundation for sound batch decisions and timely release.
The question that matters
Then we develop and validate it. For trace analysis and new active substances, this is more the norm than the exception, which is why method development is a firm part of our service range and not a special assignment. We tell you in advance whether development is necessary, how much time it will take, and whether it is worthwhile compared with commissioning a specialist laboratory. For traces at the nanogram level or below, a triple quadrupole LC-MS/MS system is available.
Our state-of-the-art, fully digitalised analytical laboratory enables fast and efficient processing of your analytical samples. You receive test results from a single source, documented in accordance with GMP and ready for inspection. Every assessment is carried out under the responsibility of the Head of Quality Control and, for batch release, also under the responsibility of a Qualified Person pursuant to § 14 AMG.
To ensure quality and safety, we carry out complete testing in accordance with your product specification, including batch release. Our range of services includes:
Your method is not listed? Please get in touch. Many further tests are carried out in collaboration with carefully selected and qualified partner laboratories.
Quality control of raw materials and starting materials, excipients and active substances. Testing for identity, assay and purity in accordance with common national and international monographs (Ph. Eur., USP) or your own specifications.
Testing of medicinal cannabis flowers and extracts is carried out in our GMP laboratory using validated methods and creates a reliable basis for market entry in the German and European markets. The testing covers the German and European pharmacopoeias.
Testing of proteins, peptides, synthetic and recombinant peptides, oligonucleotides and mRNA. Assay and purity testing, mass determinations and determination of degradation products by HPLC-MS/MS (quadrupole). Purity by RP or SEC-HPLC.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationReview the specification, check whether a method already exists, otherwise develop and validate one, or implement your existing method.
We tell you the quantity, packaging and shipping method. Receipt of the sample is documented in accordance with GMP.
Carried out in our GMP-compliant laboratory, recorded completely in the laboratory information system.
You receive the certificate of analysis along with the technical assessment, the responsibility of the Head of Quality Control.
Typical initial situations
Laboratory capacity is fully booked, and the release of your batch is still pending. You do not need additional laboratory space, but targeted capacity buffer for this batch.
A test requires specialised analytics and in-depth expertise that you do not want to maintain permanently, for example for demanding trace analysis in the sub-nanogram range.
For goods from outside the EEA originating from a non-MRA country, EU retesting is mandatory before the Qualified Person may certify the batch.
You need a sound risk assessment and, where necessary, analytical confirmation at concentration ranges that many laboratories cannot reliably cover.
Measuring range
Between the active substance concentration of a tablet and possible nitrosamines are six orders of magnitude. Anyone who can only cover the upper concentration range cannot fully guarantee a reliable nitrosamine assessment. Our triple-quadrupole system reaches down to the lowest relevant concentration ranges. This lets us confirm analytically exactly where it matters.
Our measuring range covers the entire spectrum
Triple-quadrupole LC-MS/MS for nitrosamines and aflatoxins in the nanogram range, in our own GMP-certified laboratory in Itzehoe. This gives us the analytical basis for reliable nitrosamine risk assessments, and we carry out critical tests directly in our own laboratory without having to rely on an external one.
Responsibility
You know from the start who is taking over your topic: with name, function and direct extension. Even before the start of the contract, not afterwards. And not as an anonymous team, but with a specific contact person.
Qualified Person (QP) and Head of Production
Key areas
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Qualified Person (QP) and Head of Quality Control
Key areas
Degree and doctorate in chemistry, further education in pharmacy to attain expert knowledge under § 15 AMG
Development Analytics
Key areas
Doctorate in pharmaceutical chemistry
Case studies
Anonymised projects from exactly this service, with initial situation, procedure and the final outcome.
Sponsor of clinical trials, small biotech company
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyLarge international pharmaceutical company
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
Read the full case studyWe clarify your questions in the initial consultation. Dr. Thomas Lutz takes the time for it.
Arrange an initial consultationOur analytical service range covers eight core disciplines: release testing and EU retesting in accordance with product specification, including IR, UV-VIS, thin-layer chromatography, GC-FID, HPLC, HPLC-MS/MS, loss on drying/water content, active substance release, disintegration time/tablet hardness and microscopy; raw material testing under Ph. Eur. and USP; analytics of herbal medicinal products, such as cannabis flos, including cannabis extracts; analytics of biotechnological medicinal products such as proteins, peptides, oligonucleotides and mRNA; GMP-compliant method development and validation; trace analysis by LC-MS/MS; stability testing in accordance with ICH; microbiological analytics. Not sure whether your analytical question is covered by our service range? Please get in touch for a personal conversation, we will work out together how we can support you.
Yes. Our analytical laboratory is GMP-certified. The certification confirms our laboratory's technical competence for the test methods listed in the scope of the certificate and provides a reliable basis for the assessment and documentation of analytical results.
For trace analysis, we use a triple quadrupole Agilent Ultivo 6475. This allows us to detect nitrosamines and other (geno)toxic impurities down to the sub-nanogram range, the sensitivity that a safe medicinal product typically requires. The methods are validated under GMP.
Yes. We analyse proteins, peptides, oligonucleotides and mRNA by HPLC-MS/MS with quadrupole technology. These methods are not available in-house to many clients, we provide them as a specialised service.
Then we develop it. Method development, validation and transfer under GMP are part of our service scope. This means you get a validated, regulatorily robust test method even for new or demanding questions, without having to maintain your own equipment or personnel resources. The know-how gained is available to you.
The analytical results are the responsibility of our Head of Quality Control. This gives you a personal point of contact with clearly defined statutory responsibility. Our contacts for analytical matters are available to you at the Itzehoe site.
Services that are often used together
Call us or write three lines. You will reach someone directly who can assess your subject professionally.
As a member of the Life Science Nord cluster, we benefit from a strong, innovative network and work with other experts in the industry on forward-looking developments.
