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Category: Knowledge Hub

Are you aware of the increasing demand to use greener, more sustainable organic solvent systems in small molecule formulation development?

Sustainable formulation solutions for a cytotoxic small molecule: impossible? No! Partner with us to meet the increasing demand to use more environmentally friendly solvents! As an expert in formulation and process development for small molecule drugs, we encounter many drugs that have solubility and stability issues and drug formulation development struggles i.a. with the following […]

Did you know that sterile filtration can cause a negative mass content on detergents?

At ProJect Pharmaceutics, we specialize in conducting process-mock up studies prior to technology transfer to the designated contract manufacturing organization (CMO). In a process mock-up case study about “Adsorption of detergents (kinetics and amount) during sterile filtration”, the detergent content was monitored before and after the first and second round of sterile filtration. The result […]

Did you know that according to ICHQ6 guideline the molar extinction coefficient needs to be determined experimentally for a biological drug product at least once?

Determination of the theoretical (!) molar extinction coefficient by the amino acid sequence of a biomolecule is i.a. well known in pharmaceutical industry. However, according to ICHQ6 guidelines the theoretical value ought to be supported by an empirically (!) determined value for the drug product at least once.At ProJect Pharmaceutics, we are able to determine […]

Have you ever wondered about the lyo process temperature profile of your drug product?

Here at ProJect Pharmaceutics, we can monitor temperature kinetics & distribution during lyophilization (freezing, primary & secondary drying) using our contactless infrared (IR) thermal camera system. Monitoring drying kinetics during lyophilization can support evaluation of heat transfer into vial, confirmation of product temperature in vial and optimization of the overall freeze drying process.Using the IR […]

Do you know that a short and modern freeze-drying cycle helps catching a manufacturing slot at CMOs?

Has your CMO (contract manufacturing organization) also started yet rejecting customers who show up with day-long lyophilization cycles? As securing production slots becomes increasingly challenging in today’s competitive contract manufacturing landscape, this is likely to affect more and more customers who come in with an old-fashioned, multi-step and super conservative freeze-drying cycle. At ProJect Pharmaceutics, […]

Is your lyophilization stopper safe enough for your drug product stability?

Are you sure your stopper is dry enough to be safe enough for your lyophilized drug product’s stability? Have you ever experienced increase in residual moisture content in your lyophilized drug product and could not explain why? Do you know the moisture uptake capacities & water release characteristics of your lyo stopper? An increased residual […]

Is your lyophilization cycle safe and sound?

Have you ever calculated direct and opportunity costs resulting from several day-long lyophilization cycles at your CMO? Want to get easier a slot at your CMO with an optimized cycle? Want to check your cycle for robustness prior transfer into GMP manufacturing? Tired of burning money with day-long lyophilization cycles? Longing for a slim, efficient, […]

Innovative liposome technology made GMP compatible!

Do you have a delicate molecule that is difficult to formulate and liposome encapsulation seems an elegant solution …but you fear the hurdles of processing towards grade A environment? Partner with us on packing your API in liposomes made of GRAS-status phospholipids that overcome the common hurdles of processing a liposomal formulation. At ProJect Pharmaceutics […]