Analytical Services
Dissolving your Challenges!
Avivia’s laboratory specializes in delivering comprehensive analytical services crucial for informed decision-making in drug development. We can support you in complex product characterisation, troubleshooting, reverse engineering, competitor analysis and challenging method development.
Our expert team employs a diverse array of state-of-the-art techniques, including chromatography, spectroscopy, mass spectrometry, and more, to ensure the quality, safety, and efficacy of pharmaceutical products. When the time is there we take care of the analytical method transfer to a qualified lab of choice for the final quality testing.
Avivia is an independent pharmaceutical development contracting organization in the Netherlands offering a unique, complementary range of pharmaceutical services in the areas of:
Analytical Development Services
Avivia’s laboratory specializes in delivering comprehensive analytical services crucial for informed decision-making in drug development. Our expert team employs a diverse array of state-of-the-art techniques, including chromatography, spectroscopy, mass spectrometry, and more, to ensure the quality, safety, and efficacy of pharmaceutical products.
Backed by skilled experienced scientists and advanced instrumentation, we provide precise and reliable results for method development, (pre-)validation, troubleshooting and substantive support for our formulation development services. Whether you represent a pharmaceutical company, research institution, or regulatory agency, our laboratory is dedicated to delivering the analytical insights necessary to drive innovation and ensure success.
The pharmaceutical analysis experts of the Avivia Analytical Research and Development Services know what it takes to bring a pharmaceutical drug product to the market, from discovery, feasibility to GMP. After working with over 100 unique molecules and even more formulations, we can say that we have overcome the most difficult CMC challenges and provide dedicated analytical support and analytical method development services to veterinary and pharmaceutical companies.
With our creative research mentality, we deliver what a client needs. As Analytical CRO we perform best by exploring together the motivations behind their request.
Pharmaceutical testing
Analytical method transfer
One of our analytical R&D strengths is our expertise in (physico-chemical) characterization of active pharmaceutical ingredients, drug products and the excipients.
Whether it is particle size, flowability, rearrangement mechanisms, genotoxicity, chirality or deliquescence. Or drug – excipient interaction, relaxation, reversed engineering, discoloration, spots, extractables or dissolution.
We can investigate and identify the relevance of such parameters for manufacturing, stability or intellectual property (IP).
We perform all analytical method development and analytical method verifications that are needed in the different phases, to provide optimal analytical support to the chemical and pharmaceutical development.
When the time is there we take care of the analytical method transfer to a qualified lab of choice for the final quality testing.
Analytical method transfer
We perform all analytical method development and analytical method verifications that are needed in the different phases, to provide optimal analytical support to the chemical and pharmaceutical development.
When the time is there we take care of the analytical method transfer to a qualified lab of choice for the final quality testing.
Problem solving and troubleshooting
Excipient knowledge platform
In the past decade, the Avivia analytical testing laboratory have set up an internal excipient characterization platform to study the purity and determine functionality related characteristics (FRC) of excipients like celluloses (HPMC, CMC, MCC, etc.), carbohydrates (lactose, mannose, etc.), PEO, PEG, alginate, carbomer, CPV, PVP(P), PVA, BHT, magnesium stearate, etc. Reason for this were issues with batch-to-batch variation of excipients and unpredictable stability performance of drug products.
In many cases, we have been able to find very specific excipient characteristics that are not part of the routine testing and are not featured on an excipient Certificate of Analysis (CoA) but do have a profound effect on how the excipient functions within the finished dosage. These properties are often related to the source or starting materials and the manufacturing process and conditions of the excipient. With this know-how, specific excipient batches, grades or manufacturers can be selected to design pharmaceutical formulations with improved, particular or unique characteristics.
Analytical Techniques
Our in-house analytical R&D services and analytical laboratory capabilities include techniques such as
UHPLC-MS (single quad); UHPLC-UV/DAD; UHPLC-CAD; HPLC-RI; SEC; IC; GC-MS (single quad); GC-FID;
UV spectroscopy; microscopy, scanning electron microscope (SEM); forced degradation equipment; light-stress equipment (suntester); climate chambers and more.
Other technologies and services are accessible within our extensive network, like NMR, BET, PSD, density, etc.
