Our analytical experts know what it takes to bring a pharmaceutical 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.
One of our strengths is our expertise in (physicochemical) characterization of API, excipient and drug product.
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 IP.
We develop all methods that are needed in the different phases to support the chemical and pharmaceutical development, and when the time is there we transfer these methods to a qualified lab for the final quality testing.
We can do more than execute a solution!
We work with the client to craft a more effective one, confirm they’re solving the right problem,
or even help them redefine the problem scope completely.
In the past decade, we have set up an internal excipient characterization platform to study the purity and determine functionality related characteristics (FRC) of excipients like celluloses (HPMC, 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 a 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 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, SEM;
forced degradation equipment; light-stress equipment (suntester); climate chambers and more.
Other technologies and services are accessible within our extensive network, like NMR, SEM, 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