Analytical Research & Development Services
Avivia Analytical Research and Development Services; our pharmaceutical analysis experts know what it takes to bring a pharmaceutical drug product to the market, from discovery, feasibility to GMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges that are involved.
With our creative research mentality, we deliver what a client needs. We perform best by exploring together the motivations behind their request.
Analytical method transfer
One of our strengths is our expertise in (physicochemical) characterization of the active pharmaceutical ingredient, the drug product 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 method verifications that are needed in the different phases to support the chemical and pharmaceutical development, and when the time is there we take care of the analytical method transfer to a qualified lab 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.
Our in-house analytical services and capabilities include techniques such as
UHPLC-MS (single quad); UHPLC-UV/DAD; UHPLC-CAD; HPLC-RI; SEC; IC; GC-MS (single quad); GC-FID;
Dissolution Apparatus I (basket), II (Paddle), III (Biodiss), IV (flow through cell); Pion µDiss Profiler; 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.
with MS, DAD, CAD and RI detection.
with MS and FID detection.
– Basket (USP apparatus I)
– Paddle (USP apparatus II)
– Reciprocating Cylinder (USP apparatus III)
– Flow Through Cell (USP apparatus IV)
– Pion µDiss Profiler