News

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. Expanding the offering of its service portfolio towards the French customer base, ProJect Pharmaceutics was engaged to apply at the French Ministère de L’Enseignement Supérieur, De La Recherche Et De L’Innovation for eligibility to join the French tax credit for research program (Credit d’Impôt Recherche, CIR). After successful approval for the previous years, we are proud to have again received the renewal of CIR application through 2025. We are delighted to continue to offer such big benefit to our French customers once they enter into a collaboration with ProJect Pharmaceutics.

ProJect Pharmaceutics was granted a US patent on a novel formulation which effectively stabilizes the anti-cancer drug Bendamustine and other N-mustard cancer drugs like Chlorambucil, Melphalan, Melflufen, etc. in liquid state at room temperature for up to 24 months.

LIQUID PHARMACEUTICAL FORMULATION
US-Patent No: 11,752,135
US-Application No: 17/042,795

Contact us for:
– Details of the formulation and stability data under various conditions
– Technical assistance to ensure further development and GMP manufacturing

Are you looking for a CRO that quantifies the excipients in your formulation? Particularly for high concentrated protein formulations, a deep understanding of the Donnan effect in your specific formulation is of significant importance. We at ProJect Pharmaceutics have at your disposal the expertise, as well as state-of-the art chromatographic and spectroscopic analysis methods, for quantifying a wide range of excipients. Whether it´s to determine excipient concentrations in the final manufactured drug product or for in-process control measurements, we can quantify the following excipients: Sugars and sugar alcohols, all amino acids, detergents, buffer substances, antioxidants (reduced and oxidized forms), inorganic components. This service is made available to all our clients from now on as part of a project.

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. To support our client base and next generation customers alongside their formulation development needs, the company does posts on LinkedIn on a regular basis highlighting i.e. common problems we solve for our clients, tips and tricks to overcome formulation challenges, new service offerings, general news to the company, success stories and case studies. You are invited to join our community. We would love to welcome you following the company on LinkedIn.

Do you know the molar extinction coefficient of your (biologics) drug product? According to ICHQ6 the molar extinction coefficient needs to be experimentally determined for drug products. Here 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. This service is made available to all our clients from now on as part of a project.

ProJect Pharmaceutics is proud to have contributed with its services, expertise and knowledge to develop a lyophilized i.v. injection formulation for one of its clients’ drug products which was approved by the U.S. Food and Drug Administration (FDA). Goal of the development was to move from an oral administration of the drug to an injectable one, for patients that are temporarily unable to take oral therapy thus enabling non-interruption of those patients’ therapy with the respective drug product. We congratulate our client by heart for this important achievement.

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. Expanding the offering of its service portfolio towards the French customer base, ProJect Pharmaceutics was engaged to apply at the French Ministère de L’Enseignement Supérieur, De La Recherche Et De L’Innovation for eligibility to join the French tax credit for research program (Credit d’Impôt Recherche, CIR).

We are proud to have received the CIR application for the years 2020, 2021, and 2022, and from now on to be able to offer such big benefit to our French customers once they enter into a collaboration with ProJect Pharmaceutics.

Dear customers of ProJect Pharmaceutics,

We understand that all of us are facing exceptional times due to the Corona pandemic. Knowing about the important role our employees play in our customers projects for developing innovating therapeutics, we try to deliver in these challenging times as much as possible, on-site as well as from home office. Please find in the following some proactive measures we have set to try to continue serving our global customers, but also to make sure for the safety and good health conditions of our employees, partners, valued customers and the community:

Services continuation: We do our best to deliver in ongoing customer projects, to ensure critical development timelines are met. At all times, we keep an eye on our staff’s health conditions and safety in accordance with the public health guidelines. To date, we are and will be, as far as foreseeable, able to maintain the development team at our facility. Lab personnel is working on a rotational basis in our various laboratory areas, area access is limited to one employee only at a time. The ex-laboratory project management team is partly remotely connected from home, and partly on-site, on a rotational basis. We have prioritized delivery of ongoing customer project, and de-prioritized non-critical internal initiatives.

Communication on a regular basis: Communication with our valued customers will be continued on a regular basis on the timing of operations and plans for your projects, staff availability and potential impact, if any, as per our Terms and Conditions. We appreciate your understanding that we will limit face-to-face meetings to an absolute minimum.

Employee safety: We have shaped effective measures to keep our employees as safe as possible. This includes the flexibility to work in home office, for those who can work from home. For those in roles that do not have an option to work from home, this includes rotational and flexible working schedules. This also includes active re-prioritization of activities, and rationale planning with the objective to keep control as much as possible of the evolving situation.
We thank you for your support and understanding during these exceptional times.

ProJect Pharmaceutics is glad to announce its participation as exhibitor at the upcoming CPhI trade fair, taking place in Frankfurt, Germany, November 5-7, 2019. We look forward to welcoming you at our booth #F23 in hall 9.2.

ProJect Pharmaceutics is delighted to exhibit at the upcoming Gene and Cell Therapy_Quality Developments to Commercialization Summit, taking place in Berlin, Germany, June 5-6, 2019. We look forward to welcoming you at our booth.