ProJect Pharmaceutics GmbH

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 components, inadequate primary packaging, improperly designed process parameters, or combination of those. Understanding these factors is key to optimizing your #freezedrying process and ensuring product quality and cost effectiveness. At ProJect Pharmaceutics, we are experts in #freezedrying technology and your trusted #CRO partner for lyophilization cycle development and optimization. Using high-end lyophilization technologies, we swiftly identify and address the root causes of vial breakage. Through our advanced macro-video system we perform a root-cause analysis, monitoring the entire cycle to pinpoint critical parameters that lead to product defects. Based on our findings, we develop effective avoidance strategies and provide tailored solutions to optimize your product’s process and quality. To learn more about our fields of expertise visit: https://lnkd.in/ePm5bWyF Or find more videos like this on our YouTube channel: https://lnkd.in/e4aa-CmE #processdevelopment #pharmaceuticalmanufacturing

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 > 13 years and have seen all generations of ADCs on our workbench. By combining protein formulation and process know-how with cytotoxic drug expertise the company holds unique assets to develop ADC drug products. By means of modern and advanced screening technologies we accelerate #formulationdevelopment and target a formulation that suits #antibody, linker and payload to stabilize the ADC at its "sweet spot". To learn more about our fields of expertise visit: https://lnkd.in/eQU5tep2 #cancerresearch #antibodies #antibodydrugconjugates #pharmaceuticaldevelopment

#sustainable #formulation solutions for a cytotoxic #smallmolecule: impossible? No! Partner with us to meet the increasing demand to use more #environmentallyfriendly 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 #formulationdevelopment struggles i.a. with the following pain points: a) Finding an appropriate organic solvent / solvent mixture that can dissolve the API without compromising its stability, b) many organic solvents are toxic and regulatory agencies have strict limits on the permissible levels of residual solvents in pharmaceutical products, c) removing solvents to acceptable levels can be technically challenging and costly. On top, there is increasing ecologic and social pressure to use greener, more sustainable solvent systems. Finding suitable alternatives to traditional organic solvents that are environmentally friendly can be difficult. Here at ProJect Pharmaceutics #CRO we take on the challenge together with you, we are committed to using greener solvents wherever possible: - careful selection of the least toxic & most effective solvent for the specific API - using mixtures of solvents to enhance solubility & stability profiles - utilizing advanced formulation techniques to minimize solvent use - exploring greener solvent alternatives to reduce environmental impact and improve safety. If you also want to partner with us to benefit from reduced toxicity, biodegradability, lower volatility and renewable sources when using greener solvents, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/epTwy3eF #hpapi #cancerdrugs #sustainability #greenchemistry

Did you know that sterile filtration can cause a negative mass balance for detergent content? 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 was identical: the detergent content decreased directly at the beginning of sterile filtration until the filter material was saturated and then reached the initial concentration towards the end of the filtration volume. To avoid this, follow our expert tip on double sterile filtration: a) Either discard the first x mL of the compounded, detergent-containing solution, or b) Precondition the filter material with x mL of the mixed solution. To learn more about our fields of expertise visit: https://lnkd.in/eRuDfpdQ #preclinical #formulationdevelopment #formulation #CRO

Did you know that sterile filtration can cause a negative mass balance for detergent content? 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 was identical: the detergent content decreased directly at the beginning of sterile filtration until the filter material was saturated and then reached the initial concentration towards the end of the filtration volume. To avoid this, follow our expert tip on double sterile filtration: a) Either discard the first x mL of the compounded, detergent-containing solution, or b) Precondition the filter material with x mL of the mixed solution. To learn more about our fields of expertise visit: https://lnkd.in/eRuDfpdQ #preclinical #formulationdevelopment #formulation #CRO

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 the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby, we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass. If you also need support determining the molar extinction coefficient of your biological product empirically, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/eRuDfpdQ #preclinial #drugdevelopment #antibodies #CRO

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 the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby, we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass. If you also need support determining the molar extinction coefficient of your biological product empirically, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/eRuDfpdQ #preclinial #drugdevelopment #antibodies #CRO

Have you ever wondered about the 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 thermal camera system, we can also monitor the thawing kinetics in the drug substance batch and thus i.e. detect inhomogeneous thawing behavior in the drug substance bulk container or overall duration of the thawing process. Curious? Then visit our YouTube channel to watch more videos like this (https://lnkd.in/e4aa-CmE) or contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: ProJect Pharmaceutics – Formulations for Pionieering Drugs (project-pharmaceutics.com) #processdevelopment #lyophilization #freezedrying #pharmaceuticalmanufacturing #CRO

Have you ever wondered about the 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 thermal camera system, we can also monitor the thawing kinetics in the drug substance batch and thus i.e. detect inhomogeneous thawing behavior in the drug substance bulk container or overall duration of the thawing process. Curious? Then visit our YouTube channel to watch more videos like this (https://lnkd.in/e4aa-CmE) or contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: ProJect Pharmaceutics – Formulations for Pionieering Drugs (project-pharmaceutics.com) #processdevelopment #lyophilization #freezedrying #pharmaceuticalmanufacturing #CRO

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, we are specialized in determining modern freeze-drying cycle parameters in just five (!) rounds based on a smart and firm in-house algorithm for process and formulation. A short and modern lyophilization cycle - reduces parameters, enhances robustness and simplifies validation - improves accessibility to CMOs - drives down manufacturing expenses Although one-step overnight cycles are one of our specialties, we understand that this might be too explorative for most clients. However, we are known for delivering shorter cycles than the market average. On top, we support the implementation at the commercial plant in communication with the CMO towards a seamless technology transfer. If you also would like to find out whether you can save money on freeze-drying and shorten your lyo cycle to attractive conditions, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/ePm5bWyF #processdevelopment #lyophilization #freezedrying #pharmaceuticalmanufacturing #CRO