Services · Analytical Services
Is your own laboratory at full capacity, or is a method you need unavailable or not yet established? Then it is not just the test result that is delayed: batch release can stall too. A&O Pharma takes on your samples in our GMP-certified laboratory. With fully digital workflows, we process your orders efficiently, transparently and traceably, for reliable results and short turnaround times.
No obligation, in confidence. We reply within 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 one. For trace analysis and new active substances, this is the norm rather than the exception, which is why method development is a standard part of our services and not a special assignment. We tell you in advance whether development is needed, how long it will take and whether it is more economical than using a specialist laboratory. For traces at nanogram level or below, we use a triple quadrupole LC-MS/MS system.
Our state-of-the-art, fully digitalised GMP laboratory processes your samples quickly and efficiently. You receive test results from one provider, documented to GMP standards and ready for inspection. Every assessment is made under the responsibility of the Head of Quality Control and, where batch release is involved, also under the responsibility of a Qualified Person under § 14 AMG.
To ensure quality and safety, we carry out complete testing to your product specification, including batch release. Our services include:
Your method is not listed? Please get in touch. Many other tests are carried out in cooperation with carefully selected, qualified partner laboratories.
Quality control of raw and starting materials, excipients and active substances. Testing for identity, assay and purity according to the common national and international monographs (Ph. Eur., USP) or your own specifications.
We test medicinal cannabis flowers and extracts in our GMP laboratory using validated methods, providing a reliable basis for entering the German and European markets. Testing covers both the German and the European Pharmacopoeia.
Testing of proteins, peptides including synthetic and recombinant peptides, oligonucleotides and mRNA. Assay and purity testing, molecular mass determination and determination of degradation products by HPLC-MS/MS (quadrupole). Purity by RP-HPLC or SEC-HPLC.
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationWe review the specification and check whether a method exists. If not, we develop and validate one, or implement your existing method.
We tell you the quantity, packaging and shipping route. Sample receipt is documented in line with GMP.
Performed in our GMP-compliant laboratory and fully recorded in the laboratory information system.
You receive the certificate of analysis with a technical assessment, for which the Head of Quality Control is responsible.
Typical starting points
Your laboratory capacity is fully booked, and your batch is still waiting for release. What you need is not more laboratory space but extra capacity for this batch.
A test requires specialised analytical methods and in-depth expertise that you do not want to maintain permanently, for example demanding trace analysis in the sub-nanogram range.
For products from outside the EEA from a country without a mutual recognition agreement (MRA), EU retesting is mandatory before the Qualified Person may certify the batch.
You need a sound risk assessment and, where necessary, analytical confirmation at concentrations that many laboratories cannot reliably measure.
Measuring range
Six orders of magnitude separate the active substance content of a tablet from potential nitrosamine levels. A laboratory that can only cover the upper concentration range cannot fully support a robust nitrosamine assessment. Our triple quadrupole system reaches down to the lowest relevant concentration ranges, so we can confirm results analytically exactly where it matters.
Our measuring range covers the full spectrum
Triple quadrupole LC-MS/MS for nitrosamines and aflatoxins down to the nanogram range, in our own GMP-certified laboratory in Itzehoe. This gives us the analytical basis for robust nitrosamine risk assessments, and we carry out critical tests in-house without relying on an external laboratory.
Responsibility
You know from the start who will handle your project: name, position and direct phone number. Before the contract starts, not afterwards. Not an anonymous team, but one specific contact.
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, postgraduate pharmacy programme to acquire the expert knowledge required under § 15 AMG
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Head of Quality Control
Key areas
Degree in chemistry followed by a doctorate in supramolecular chemistry.
Case studies
Anonymised projects from this service: starting point, approach and outcome.
Clinical trial sponsor, small biotech company
A new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight, pro...
Read the full case studyLarge international pharmaceutical company
A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, import w...
Read the full case studyWe will answer your questions in an initial consultation. Dr. Thomas Lutz will take the time to go through them with you.
Book an initial consultationOur analytical services cover eight core disciplines: release testing and EU retesting to product specification, including IR, UV-VIS, thin-layer chromatography, GC-FID, HPLC, HPLC-MS/MS, loss on drying/water content, dissolution, disintegration/tablet hardness and microscopy; raw material testing to Ph. Eur. and USP; testing of herbal medicinal products such as cannabis flos, including cannabis extracts; testing 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 line with ICH; and microbiological testing. Not sure whether your analytical question is covered? Please get in touch and we will work out together how we can support you.
Yes. Our analytical laboratory is GMP-certified. This provides a reliable basis for the assessment and documentation of analytical results.
For trace analysis, we use an Agilent Ultivo 6475 triple quadrupole. This allows us to detect nitrosamines and other (geno)toxic impurities down to the sub-nanogram range, the sensitivity usually needed to ensure a medicinal product is safe. The methods are validated under GMP.
Yes. We analyse proteins, peptides, oligonucleotides and mRNA by HPLC-MS/MS using quadrupole technology. Many clients do not have these methods in-house, so we provide them as a specialised service.
Then we develop it. Method development, validation and transfer under GMP are part of our services. This gives you a validated test method that will stand up to regulatory scrutiny, even for new or demanding questions, without having to maintain your own equipment or staff. The know-how gained is available to you.
Our Head of Quality Control is responsible for the analytical results. This gives you a personal contact with clearly defined statutory responsibility. Our analytical contacts are based at our Itzehoe site.
Services that are often used together
Call us or write a few lines. You will reach someone who can assess your request with real expertise.
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.
As a registered supplier on Scientist.com, we can also be reached through this platform: companies registered there can send their project requests directly to us.
