News

Introducing formulation and lyophilization process development for cytotoxic and other highly potent drugs

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.

Joint Development of a novel lyophilized Dual Chamber Prefillable Syringe System

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

Check your Lyo Cycle!

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.

Formulations for clinical trials and beyond

Budget is often scarce for pharmaceutical development projects before the drug has even shown proof of concept in first clinical trials. In that early stage, many drug developing companies are hesitant to spend the money for a fully-fledged pharmaceutical development of the formulation.

Thus, quite often formulations in preclinical studies and clinical stages I and II are far from being rationally designed. Particularly when it comes to therapeutic proteins, where formulation development is highly challenging due to the structural complexity and instability of the compound, pharmaceutical quality issues are the likely consequence.

Once proof of concept has been established with the rudimentary formulation, pharmaceutical companies are reluctant to change this formulation due to concerns of jeopardizing the data obtained so far in preclinical and early clinical testing.

As a result, formulations reflecting an early preclinical development status often find their way into pharmaceutical dossiers, and authorities frequently deny approval of numerous drug applications due to the lack of pharmaceutically sound data documenting state-of-the-art formulation and process development.

The key to overcome this dilemma is Predictive Formulation Analytics offered by ProJect Pharmaceutics: Plying state-of-the-art analytical methods permits us to characterize the protein molecule and analyze its response to certain excipients with regard to its intra and intermolecular physicochemical properties. This allows us to quickly and reliably identify those combinations of pH value, ionic strength, ion types, detergents and other stabilizing agents, which preserve the active 3 dimensional structure of the protein in an ideal manner.

Costs, timelines and the amount of API required for this highly efficient approach towards a rational and reliable formulation for clinics and beyond is surprisingly low.

Our deliverable will be a science-based formulation for a freeze dried product of your drug, and a conventional lyophilization cycle, ready for tech transfer to GMP manufacturing.

Once your drug has mastered critical milestones in early clinical development, call on us to carefully work out the final formulation of your drug, by means of an in-depth experimental program, to verify or optimize the quantitative composition of the drug product tailored to the route of application, the delivery system and the pharmaceutical manufacturing process.

ProJect Pharmaceutics introduces Predictive Formulation Analytics for a rational design of optimized biopharmaceutical formulations.

Munich/Martinsried, December, 2011

Protein drug formulation is particularly challenging due to structural complexity and instability. The biological activity of most recombinant proteins emanates specifically from their 3-dimensional structure which needs to remain unaltered throughout the shelf-life of the product. However, cleavage or aggregation incidents may not only reduce efficacy but also produce adverse immunologic effects.

The current industry standard for the formulation development of biopharmaceutical drugs is a time consuming, trial-and-error driven process which requires accelerated stability testing to identify the best out of many formulation alternatives. Occasionally, the large number of formulation options is tested by means of high throughput screening, yet accepting the potential drawback of a highly artificial testing environment.

Predictive Formulation Analytics from ProJect Pharmaceutics offers an innovative scientific approach for designing optimized protein formulations and reduces the need for extensive stability testing.

Plying state-of-the-art analytical methods to characterize the physicochemical state of proteins and analyze their response to certain excipients allows us to quickly and reliably identify promising formulation candidates.

The stability of proteins in solution is mainly determined by intramolecular and intermolecular interactions. Intramolecular stability is characterized by protein thermodynamics which are measured by means of nano differencial scanning calorimetry (nanoDSC). Intermolecular stability is represented by the attractive or repulsive interaction between protein molecules which is quantified via composition gradient static light scattering (2nd virial coefficient).

A systematic algorithm based on design of experiments (DOE) is used to determine the most favorable composition for the native structure of a given protein with regard to its intra- and intermolecular physicochemical properties. Beneficial effects resulting from pH value, ionic strength, ion types, detergents and other stabilizing agents can be identified and quantified without stability testing.

The data obtained from our research provide the basis for a drug product composition that is tailored to the protein, its packaging system and its application. A final stability test program, carried out on samples filled into the final packaging system under genuine pharmaceutical manufacturing conditions, serves to confirm the suitability and stability of the composition and provides trustworthy data for initiating clinical trials.

For more information please visit: www.project-pharmaceutics.com or contact:

ProJect Pharmaceutics GmbH
Fraunhoferstraße 22
D-82152 Martinsried
+49 (0) 89 452289700

Media Relations:
DenkLeistung Kommunikation
Monika Schlesinger
++49 (0)8141 539702
">

Media Service:
ProJect Pharmaceutics offers the free download of high-res images.

EuroBioTechNews: From development to launch

Developing a new drug that addresses an unmet medical need is a challenging but rewarding objective in the life of a drug-development scientist. But even after a candidate has been identified and regulatory hurdles successfully cleared, there are always a set of new challenges that loom on a new drug’s path to commercial scale manufacturing.

Because time-to-market, risk reduction and production costs heavily influence the overall success of new products, the best time to optimise these key factors of success are the very early planning and development stages of the process, while various options are still under consideration. Managing individual steps from drug development to large scale manufacture requires an approach that efficiently balances know-how between formulation science, pharmaceutical process development and drug delivery technologies, while at the same time meeting the highest standards of quality, safety and stability.

In an era of increasing globalisation and a constantly changing pharmaceutical value chain, top-notch efficiency in developing new drugs – coupled with profound expertise and highly reliable quality of outsourced services – are the biggest hurdles for competitive pharmaceutical companies facing a challenging market environment.

To meet client demand, ProJect Pharmaceutics has developed a unique process for constantly planning, controlling and auditing this highly complex service, thus making it as transparent as possible for areas like risk reduction, time-line definition and cost efficiency.

Advaceutics

Advaceutics – a combination of the terms advantage and pharmaceutics – is the trademarked approach developed by ProJect Pharmaceutics that ensures seamless and integrated process management during all of the required steps that trans- form proteins, peptides and delicate small molecules into a manufacturable drug. Optimised and tailor-made solutions de- veloped under the Advaceutics regime reflect the holistic approach we take from the very beginning, encompassing vital aspects such as safety, stability and cost effective manufacturing, helping to ensure that the process can be transferred smoothly to large-scale GMP manufacturing at a later stage.

Advaceutics is therefore the overall modus operandi for safeguarding client projects. In short, it comprises the following steps:

  • defining the optimal pharmaceutical strategy for a perfect drug presentation through comprehensive consulting
  • applying innovative, science-based technologies to stabilise the native 3D structure of proteins most effectively and reliably throughout the entire shelf life
  • developing innovative depot formulations and drug delivery systems for optimised pharmaceutical action
  • identifying the ideal packaging system and delivery device for the drug formulation considering convenience, safety and stability aspects
  • developing reliable and cost-effective manufacturing processes for a pharmaceutical system
  • selecting and qualifying the most suitable CMO for the pharmaceutical system and transferring the technology into large-scale GMP manufacturing

The Advaceutics process ensures that pharmaceutical clients receive the best solution at the best possible time (with reliable, pre-defined time lines) and a strict management of process risks. Although ProJect Pharmaceutics does not develop pioneering drugs on its own, our team believes it is just as rewarding to actively ensure our clients’ future market success by preparing drugs for market.

“From development to launch”, by Dr. Andreas Schütz and Klaus Hellerbrand, ProJect Pharmaceutics GmbH, Martinsried, Germany, in: EuroBioTechNews, Special: Biomanufacturing, No 7-8, Vol 10, 2011, p. 30

Introducing an optimized process management concept from drug development to drug manufacturability: Advaceutics®

Reducing risk, defining time lines and increasing cost efficiency on a new drug’s way to commercial scale manufacturing.

Munich/Martinsried, August 25, 2011 – ProJect Pharmaceutics (www.project-pharmaceutics.com) ProJect Pharmaceutics (PJP), who started operations last year, introduces its innovative approach Advaceutics ® to balance the know-how between formulation science, pharmaceutical process development and drug delivery technologies efficiently. Advaceutics ® – a combination of the terms advantage and pharmaceutics – ensures seamless and integrated process management during all required steps that transform proteins, peptides and delicate small molecules into a manufacturable drug. Optimized and tailor-made solutions developed under the Advaceutics ® regime reflect PJP’s holistic approach, encompassing all vital aspects such as safety, stability and cost-effective manufacturing, in order to ensure that the process may be transferred smoothly to large scale GMP manufacturing at a later stage.

Advaceutics is PJP’s overall modus operandi safeguarding client projects and, in short, comprises the following steps:

  • defining the best pharmaceutical strategy for a perfect drug presentation by offering thorough consulting
  • applying innovative, science-based technologies to stabilize the native 3D structure of proteins most effectively and reliably throughout the entire shelf life
  • developing innovative depot formulations and drug delivery systems for optimized pharmaceutical action
  • identifying the ideal packaging system and delivery device for the drug formulation considering convenience, safety and stability aspects
  • developing reliable and cost-effective manufacturing processes for the pharmaceutical system
  • selecting and qualifying the most suitable CMO for the pharmaceutical system and transferring the technology into large-scale GMP manufacturing

As time-to-market, risk reduction and production costs influence the overall success of the new product heavily, the best time to optimize these key factors of success are actually the very early planning and development stages of the process during which various options are still under consideration. In times of increasing globalization and a constantly changing pharmaceutical value chain, capital efficiency in developing new drugs, paired with profound expertise and highly reliable quality of outsourced services, are ever important for competitive pharmaceutical companies facing a challenging market environment. To meet this client demand, ProJect Pharmaceutics developed a unique process to plan, control and audit its highly complex service at all times, thus making it as transparent as possible with regards to risk reduction, time line definition and cost efficiency.

ProJect Pharmaceutics is an exhibitor at CPhI in Frankfurt, October 27 to 29, Hall 4.1, Booth 41D42

For more information please visit: www.project-pharmaceutics.com or contact:

ProJect Pharmaceutics GmbH
Fraunhoferstraße 22
D-82152 Martinsried
+49 (0) 89 452289700

Media Relations:
DenkLeistung Kommunikation
Monika Schlesinger
++49 (0)8141 539702
">

Media Service:
ProJect Pharmaceutics offers the free download of high-res images.

Transforming proteins into pioneering drugs – ProJect Pharmaceutics started operations

New pharmaceutical service provider ProJect Pharmaceutics recently opened facility in Munich/Martinsried

Munich, December 13, 2010 – ProJect Pharmaceutics started business operations and opened its laboratory facilities in the Biotech-cluster in Martinsried, near Munich. ProJect Pharmaceutics (PJP) transforms proteins, peptides and delicate small molecules into pioneering drugs.

Adding value to client’s bio-therapeutic products is PJP’s mission, focused in an innovative concept of biopharmaceutical development called Advaceutics. Based on the Advaceutics concept, ProJect Pharmaceutics designs optimized pharmaceutical formulations and delivery systems that are stable, convenient and safe. Tailored to these optimized systems the company develops cost-effective manufacturing processes and transfers those from its own pilot labs to large-scale manufacturing. ProJect Pharmaceutics makes sure that investigational products as well as new presentations of registered drugs are developed effectively and will run smoothly in clinical and commercial scale GMP manufacturing.

ProJect Pharmaceutics was founded and is managed by Andreas Schütz and Klaus Hellerbrand, two leading experts in protein formulation and pharmaceutical process development with many years of experience in bio-pharmaceutics. Their combined expertise and complementary set of qualifications enables ProJect Pharmaceutics to deliver the high-tech pharmaceutical services the team is known for and that are in increased demand for the global biopharmaceutical industry.

“In times of an increasingly globalizing and changing pharmaceutical value chain, capital efficiency in developing new drugs, paired with deep expertise and highly reliable quality of service are ever important for competitive pharmaceutical companies facing a challenging market environment”, says Dr. Andreas Schütz, Managing Director and Founder of Project Pharmaceutics.

“We started our operations with an experienced team of biopharmaceutical professionals and already are working on several exciting projects”, comments Klaus Hellerbrand, Managing Director and Founder.