FDA approval of a client’s small molecule drug product for i.v. injection

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 receives CIR application (Research Tax Credit) for the benefit of its French customers

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.

Business Continuity Statement in the course of the global SARS-CoV-2 pandemic

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.

Meet ProJect Pharmaceutics at CPhI 2019

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.

Meet ProJect Pharmaceutics at CPhI 2018

ProJect Pharmaceutics is glad to announce its participation as exhibitor at the upcoming CPhI trade fair, taking place in Madrid, Spain, October 10-13, 2018. We look forward to welcoming you at our booth #14.1 D 92.

ProJect Pharmaceutics enters into collaboration with business partners in Asia

ProJect Pharmaceutics is delighted to expand the global presence of its service portfolio towards the Asian market. Entering into a collaboration with business partner BiGEN in South Korea, ProJect Pharmaceutics becomes a cross-country competence hub for formulation and process development.

On top, ProJect Pharmaceutics can now offer its clients to act as a gate opener to the Asian market with regard to drug substance manufacturing as well as drug product commercialization.

Meet ProJect Pharmaceutics at BIO 2018

ProJect Pharmaceutics is glad to announce its participation as exhibitor at the upcoming BIO International Convention trade fair, taking place in Boston, U.S.A., June 4-7, 2018. We look forward to welcoming you at our booth #1443.

Formulation and lyophilization process development for live virus vaccines

ProJect Pharmaceutics expands its service portfolio to meet customer’s increasing need for the development of GMO S2 and BSL-2 biological products including live viruses.

ProJect Pharmaceutics is one of the leading European service providers offering tailored pharmaceutical formulations and lyophilisation processes for therapeutic proteins, peptides and other therapeutic compounds.

New safety facilities in dedicated labs and a deep understanding of the challenges when processing virus vaccines enable ProJect Pharmaceutics to provide specific solutions for this group of products of high complexity.

Smart formulations and manufacturing processes to safeguard the efficacy of the finished drug product are provided together with mandatory safety requirements up to GMO S2 and BSL-2 classification.

Maintaining the native quaternary structure of the virus capsid and avoiding virus aggregation is the key to maintain its full biological activity even under stress conditions like elevated temperature, freezing and freeze drying. Cutting-edge analytical high-throughput methods have been implemented in our biological safety lab in order to select the most effective combination of excipients for the final drug product. The GMO S2 and BSL-2 safety lab is equipped with a dedicated pilot freeze dryer to design tailored lyophilisation cycles both maximally robust and efficient. PJP’s long lasting experience and comprehensive know-how of lyophilisation enables our customers to follow new paths in process technology. Customers will benefit from safer products with an optimized stability profile and reduced manufacturing costs.

For more information please visit: www.project-pharmaceutics.com or contact:
ProJect Pharmaceutics GmbH
Fraunhoferstraße 22
D-82152 Martinsried
+49 (0) 89 452289700

ProJect Pharmaceutics enters collaboration with German CMO as the preferred development partner for lyophilization

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. Adjacent to its service portfolio, ProJect Pharmaceutics operates a broad network towards contract manufacturing organizations (CMOs) for drug substance and drug product to support its clients towards selecting the best fit for their products’ manufacturing requirements.

As state-of-the-art development experts ProJect Pharmaceutics is teamed up with state-of-the-art manufacturing experts at LYOCONTRACT GmbH to provide high-quality parenterals from pre-clinical to clinical and large commercial scale.

ProJect Pharmaceutics’ clients can profit from a direct line to a) liquid fill & finish services on a modern filling line, and b) manufacturing of lyophilized products for clinic and market supply on high-class commercial lyophilization plants.

The CMO’s clients can profit from a direct line to lyophilization cycle development and/or optimization towards a robust but efficient lyo cycle design – an efficient lyo cycle can not only safe our clients time and thus pure money on manufacturing batches, but also facilitate to get a manufacturing slot way easier at CMOs by not blocking the manufacturing line for days or weeks