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.
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 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.
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 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
Munich, October 29, 2015 – ProJect Pharmaceutics introduces a science-based approach to develop best-in-class formulations for convenient use in pre-filled syringes
Transforming therapeutic proteins into high-concentrated, stable and easy to use medications for subcutaneous self-injection can add up to a major challenge along their clinical development. A formulation’s fundamental qualifications such as appropriate physico-chemical stability, container material compatibility and viscosity must be taken into account to support an acceptable in-syringe shelf-life as well as convenience in regard to syringe-ability. However, in order to take all of the requirements to a maximum and develop a pioneering new drug in a pre-filled syringe presentation, a great extent of knowledge, expertise and sophisticated analytics is needed that are sparingly found in this developing market to date.
ProJect Pharmaceutics, one of the experts in formulation and process development for parenteral drugs, has specialized in this emerging field with a key expertise in development of stable, effective and syringe-able formulations and their eligible processes. Be it conformation of de novo drug products towards a pre-filled syringe application or transfer of existing drug products into the like, ProJect Pharmaceutics features all the required key qualifications in that field.
By applying an elaborate science-based approach to meet well-discussed critical quality attributes such as e.g. maximum effectiveness, high concentration for low injection volume, low aggregate content and low viscosity, ProJect Pharmaceutics offers profound guidance and support on the development of pioneering parenteral biologics.
‘Predictive formulation analytics’ positions ProJect Pharmaceutics towards a rational design of high-concentrated but low viscous and easy injectable formulations:
Minimizing viscosity and aggregation by actively maximizing repulsive protein-protein interaction in solution is one of the key techniques used. Additionally, shifting thermodynamic protein stability in solution to its maximum prove another key requisite promoting long-term stability of liquid formulations in pre-filled syringes.
Designed formulations’ syringe-ability is measured directly in-system mimicking the typical administration procedure of the patient instead of through viscosity only.
In case stability in aqueous solution is found to be limited by the biologic ́s inherent sensitivity freeze-drying clears the way forward. Innovative design of lyo-formulations and freeze-drying processes developed by ProJect Pharmaceutics reliably overcome the hurdles of reconstituting high-concentrated protein lyophilizates.
Supply of aseptic pre-clinical study material in pre-filled syringes at pilot scale complete ProJect Pharmaceutics’ excellence as your pharmaceutical service provider in this exigent field of highly concentrated protein formulation development.
ProJect Pharmaceutics announces that it has signed a development agreement with ImevaX, a spin-off project from the research group of Prof. Dr. Markus Gerhard from the Technische Universität München, Institute for Medicinal Microbiology, Immunology and Hygiene, aimed at developing a formulation for a recombinant vaccine against Helicobacter pylori. IMX101 is a multicomponent vaccine, making the formulation development particularly challenging.
The contract covers activities in developing a rational formulation based on ProJect Pharmaceutics´ Predictive Formulation Analytics. This technology offers an innovative scientific approach for designing optimized protein formulations by determining the most favorable composition for the native structure of the protein with regard to its intra- and intermolecular physicochemical properties. By analyzing the response to certain excipients the most promising formulation candidates can be identified quickly and reliably reducing the need for extensive stability testing.
Promising formulation candidates have successfully been evaluated and are continuously optimized within the development program since its launch in mid 2013. Financial terms of the current agreement are not disclosed.
About project ImevaX
As part of the GO-Bio start up program of the German Ministry of Research and Education (BMBF), the TUM-based Spin-off project ImevaX from the research group of Prof. Dr. Markus Gerhard from the Technische Universität München, Institue for Medicinal Microbiology, Immunology and Hygiene, develops highly specific vaccines against pathogens that cause chronic infectious diseases. Its technology identifies immune modulatory bacterial factors that are then used to develop effective vaccines against infections of global relevance. ImevaX is planned to be founded as a biotech company in 2014.
For more information please visit: www.imevax.com or contact:
Medizinische Mikrobiologie, Immunologie und Hygiene
Trogerstraße 30
D-81675 München
+49 (0) 89 4140 2477
Prof. Dr. Markus Gerhard:
ProJect Pharmaceutics expands its service portfolio to meet customer’s increasing need for the development of cytotoxic and other highly potent drugs such as immunotoxins.
ProJect Pharmaceutics is one of the leading European service providers offering tailored pharmaceutical formulations and lyophilisation processes for therapeutic proteins and peptides.
New safety facilities in dedicated labs and a deep understanding of the challenges when processing highly potent drugs enable ProJect Pharmaceutics to provide specific solutions for cytostatic agents and immunotoxins.
Many pharmaceutical ingredients of this class show limited solubility in water and degrade rapidly during compounding, filling and freeze-drying. Smart formulations and manufacturing processes to safeguard the efficacy of the finished drug product are therefore required.
PJP’s long lasting experience and comprehensive know-how of lyophilisation from various kinds of solvent systems enables our customers to follow new paths in process technology for highly potent drugs. Customers will benefit from safer products with optimized impurity profile and reduced manufacturing costs.
Tokyo (Japan) and Munich/Martinsried (Germany), June, 2012
Arte Corporation and ProJect Pharmaceutics have been working closely on the development of a new type of dual chamber prefillable syringe for freeze-dried pharmaceuticals.
The two companies have joined together with the objective to provide innovative dual chamber syringes for the global pharmaceutical market. This type of device, called Lyo- DCPS, will be delivered in standard nests and tubs to comply with the industrial standard for aseptic filling of nested syringes. The abbreviation Lyo-DCPS stands for lyophilized dual chamber prefillable syringe.
Teamed-up in new concept development
Arte Corporation contributes its manufacturing expertise on high quality pharmaceutical packaging systems specifically in the field of prefillable syringes. ProJect Pharmaceutics, for its part, adds its know-how in developing filling and freeze drying processes and adapts the Lyo-DCPS design to enable GMP-conformity and efficient manufacturing processes for clients’ drug products.
Nested Dual Chamber Syringes for Filling and Freeze Drying on Common Filling Lines
Like conventional mono chamber syringes Lyo-DCPS will be delivered in standardized nests and tubs and can be filled on widely used nested syringe fillers. The diluent is filled first and can be autoclaved as required by international guidelines. The drug solution is filled into the second chamber and completely sealed on the filling line before entering the freeze drier. Due to its special design, the system opens by itself within the freeze drier enabling lyophilization of the drug solution in presence of the diluent.
The development has reached pilot scale and lyophilization of first customers ́ products in the new device has been performed successfully. Sterile nested Lyo-DCPS for GMP manufacturing of drug product will be available early 2013.
About Arte Corporation
Arte Corporation based in Tokyo and Takahagi City, Japan, is Japan ́s leading manufacturer of pharmaceutical glass packaging systems like ampoules, vials, cartridges and PrefillableTM syringes.
For more information please visit: www.artecorp.co.jp or contact:
Arte Corporation Headquarters/Sales Office:
5F NK Bldg.
2-8-12, Iwamoto-cho, Chiyoda-ku
Tokyo, 101-0032 Japan
+81-(0)3-3861-2881
About ProJect Pharmaceutics GmbH
ProJect Pharmaceutics, based in Martinsried/Munich, Germany, develops pharmaceutical formulations freeze drying cycles and manufacturing processes for biopharmaceutical dug products.
For more information please visit: www.project-pharmaceutics.com or contact:
ProJect Pharmaceutics GmbH
Fraunhoferstraße 22
D-82152 Martinsried
+49 (0) 89 452289700
Have you ever calculated the drawback on direct and opportunity costs when your freeze dryer is blocked by lyophilization cycles which take several days?
Take this opportunity and have your cycle parameters checked for 2,000 € only. Just send us your lyophilization process parameters, a printout of an actual lyo run and some samples.
Our experts will carefully analyze the data and identify any potential for process risk and process time reduction through:
product quality risk assessment
detection of technical weaknesses
scale-up risk assessment
potential product quality improvement
potential cycle length reduction
Call on us to optimize the freeze drying cycle in our pilot lab and transfer a high speed cycle back to your GMP facility. New paths in program design empower us to quickly and efficiently generate a dry and elegant lyophilizate without compromising process reliability and product stability.
To safeguard transferability of the results we analyze the technical design and resulting capabilities of your production freeze dryer and adapt our advanced and highly flexible pilot freeze dryers to these conditions.
Moreover, we determine critical lyophilization parameters and explore the design space, for those parameters, in a well-defined robustness program according to ICH Q8. This approach significantly reduces the technology transfer risk from pilot scale to commercial scale production.
