Why is a strong ADC formulation development a make-or-break step in clinical success?
Antibody-drug conjugates (ADCs) are among the most promising modalities in oncology – but bringing them into the clinic isn’t straightforward. One of the most underestimated challenges? Formulation development. ADCs combine three fragile components – an antibody, a linker, and a highly potent payload. Each can degrade in different ways, and if the formulation doesn’t control […]
Is next level Multi-Attribute Analysis by LC-MS becoming the new regulatory standard?
If so, we are prepared. We recently expanded our lab space, now home to our newest acquisition: the Orbitrap Exploris 240 LC-MS. LCMS (Liquid Chromatography Mass Spectrometry) is rapidly emerging as a preferred technology for Multiple-Attribute Analysis (MAA), especially for complex biologics. By consolidating into a single, information-rich run what previously required multiple chromatographic methods […]
Why is it risky to lock in your drug product formulation before testing its in-use stability?
In-use stability studies are typically conducted in the later stages of drug development – once the DP formulation has been finalized and just before entering clinical trials and the regulatory approval phase. However, this can be very risky as the recovery rates of infusion devices and the adsorption phenomena on contact materials (syringes, CSTDs, infusion […]
Did you know that in-use stability studies conducted earlier than shortly before clinical trials can protect you from unpleasant surprises?
Did you know that a drug candidate whose formulation development is supported by early in-use stability studies has a higher chance of making it through the clinic? Optimizing formulation and packaging to improve stability during use can lead to a higher-quality product. The early detection of in-use stability issues enables timely corrective action before the […]
Looking for a development partner offering in-use stability studies for injectable drug products to enter clinical trials?
At ProJect Pharmaceutics CRO, we offer the expertise and flexibility to replicate your clinical trial conditions to evaluate the stability of your drug product during real application scenarios. Whether administered through bolus injection or infusion, we can replicate your specific procedures using the relevant materials and equipment (e.g. perfusor syringe pump, Closed System Drug-Transfer Device […]
Did you know that the process for a finished dosage form (FDF) such as a lyophilization cycle can be changed & optimized during a tech transfer?
Changing and optimizing a process such as a freeze drying cycle during a technology transfer for finished dosage forms (FDF) can not only improve efficiency, reduce costs, enhance product quality but can often also profit from innovations and advanced technologies that the new site has to offer. Furthermore, there are new possibilities to adapt the […]
How to determine the optimal secondary drying time during lyophilization?
Determining the optimal secondary drying time in a lyophilization (freeze drying) cycle for drug products is critical for several reasons related to product quality, stability, and manufacturing efficiency: Optimizing the secondary drying time during drug development is essential to balance quality, cost, and efficiency while ensuring compliance with regulatory standards and delivering a stable, effective […]
Is controlled nucleation the right choice for your drug product?
In some cases, controlled nucleation (CN) significantly improves the quality of lyophilized products. In other cases, it is just a waste of time.How to find out, quickly and reliably?Experience the difference – complex science, made simple: We at ProJect Pharmaceutics are experts in freeze drying technology and a trusted CRO partner for lyophilization cycle development […]
How to avoid vial breakage in lyophilization?
Vial breakage is a serious problem in the sterile production of a lyophilized pharmaceutical. In addition to product loss, the contamination of the freeze dryer with product residues and glass fragments poses a high risk and requires considerable cleaning effort. Vial breakage is often caused by factors like thermal and mechanical stress, crystallization of formulation […]
How to accelerate and build quality into the formulation development process of complex modalities like ADCs?
Transform your delicate ADC molecule into a stable quality product with our expert CRO formulation services!ProJect Pharmaceutics is a CRO specialized in formulation and lyophilization process development for antibody-drug conjugates. We have been developing ADCs in our dedicated safety laboratories for > 15 years and have seen all generations of ADCs on our workbench. By […]