- Efficient formulation development leads to up to 60 % time and cost savings
- Modular or integrated solutions are available
- Qualified service partners provide own expertise
Efficient systems for automated formulation development save valuable research time, and they can also reduce material consumption while producing betterl out-comes. These systems are used in the development of coatings in the chemical industry, healthcare products and drugs in the pharmaceutical industry and in bio-technology. A review of current technologies and trends highlights opportunities for product developers, system manufacturers and development partners in industry and the research sector. They come together at ACHEMA 2015.
In drug discovery, high-performance formulation development systems play a pivotal role in the advancement of medical science. According to management consultants CRA Interna-tional, companies can expect to spend up to $1.6 billion for market introduction of a drug containing a new active ingredient. Novartis, one of the world’s leading pharmaceutical producers, reports that the drug development process from conception to approval takes an average 12 years. The Novartis Group in Germany currently has around 200 in-house clinical development projects underway.
Drug research in Germany is financed almost exclusively from private investment, special initiatives and funding programs. As a result, time and cost efficiency are crucial factors in medical progress. During development of a new drug, researchers evaluate up to two million compounds. Only a single relevant active ingredient will eventually be selected and submitted for approval.
Up to 60% time and cost savings
Information provided by Bosch indicates that lab process automation in the chemical indus-try can increase lab efficiency by a factor of 2.5, producing time and cost savings of up to 60%. The different industries set very high standards for cost-efficient time to market and dependable product quality. Manufacturers as well as product and system developers respond to these challenges at various levels. Ongoing technological advances in automated processing and companies with highly specialized lab structures which have established partnerships with the pharmaceutical, chemical and biotechnology industry are at the forefront of current developments. Comparisons between trials based on manual and auto-mated formulation development show that researchers arrive at different outcomes depend-ing on which option they choose. In a manual process, certain excipients could possibly be determined to be unsuitable for a product. However in automated trials, the very same compounds could prove to be beneficial when tried in combination with other substances.
Development platforms for the entire product development process
Special development platforms are designed to run simple or complex automatable devel-opment processes. Various suppliers offer modular systems or complete robotic platforms to suit a variety of needs throughout the development process, ranging from design of experiments to sample selection and processing as well as evaluation, analysis and data mining. Chemspeed Technologies, for example, supplies complete modular systems. The company’s first fully integrated liquid & solid phase synthesis robot speeds up synthesis by a factor of 100 to 1000. Founded in 1997, Chemspeed Technologies has produced a series of patented innovations for the chemical industry (Life Science, Materials Science, Com-modities) including overhead gravimetric dispensing of solids, liquids, high viscosity fluids, paste and wax (e.g. for solids from <1mg to hundreds of g) in combination with high-precision reactor, formulation vessel, application and test technologies
Modular solutions for lab-specific requirements
Various suppliers market flexible, modular solutions for formulation development, which can be adapted to individual needs and process flows. The various modules feature a uniform technology base and can be combined as needed. Workflow managers help regulate the lab processes using standardized software. Specialized systems which can be integrated into automated lab systems also support efficient workflows in highly specialized research. Solutions provided by companies such as Chemspeed Technologies and Zinsser Analytic can be used for selective optimization of lab processes during the search for active ingre-dients as well as in combinatorial chemistry, screening and synthesis. In the case of Zinsser, this includes a high-throughput synthesizer capable of performing more than 800 liquid and solid syntheses in parallel and a peptide synthesizer for peptide libraries which the company claims can process 864 peptides in 30 hours. One of the latest innovations in formulation development is a pipetting tool for liquid handling systems, which includes precision dosing capability for high viscosity substances. This feature is needed for sample preparation during the development of healthcare products, lubricants and polymers. Bosch has taken a similar approach on its BLS Syringe (Bosch Lab Systems) which was originally developed for the chemical industry and is also suitable for use in pharmaceutical labs. Whereas simple liquid suctioning pushes conventional dosing systems to their limits, the BLS Syringe is designed to handle media of varying consistencies including high viscosity substances. Filled without enclosed air, the syringe can also be used as a reaction vessel if needed.
Particle size determination for multi-phase systems
A BASF robotic high-throughput screening system can be used for automated particle size determination which is needed for development of multi-phase systems (emulsions and dispersions). The system supports fully automatic screening of formulations including the constituents which characterize them. The objective is targeted, time-saving statistical analysis of the recipe and product characteristics to support efficient formulation develop-ment. The manufacturer claims that integrated particle size measurement on the system provides the basis for highly accurate qualitative formulation assessment. The process is as follows. After experimental design, the dosing robots on the system dispense the required amounts of selected compounds. The compounds are homogenized by shaking, stirring, ultrasound or ultra-turrax in homogenization stations. The samples are then in an optimal state for rheology (flow characteristics), stability and particle size analysis. For particle size determination, a Beckman Coulter laser diffraction analyzer with patented PIDS technology (polarization intensity differential scattering) is used, which is capable of very high resolution particle detection down to the submicron range. The data obtained is automatically transferred to the lab information system (LIMS) where it is available for further analysis.
Qualified development and service partners
Companies such as Evonik Industries and specialized suppliers such as Siegfried Holding have highly qualified staff and a broad portfolio of in-house lab facilities which are ideally suited to support formulation development by customers in the pharmaceutical industry. Siegfried Holding acts as an integrated supplier which provides tailored formulation devel-opment solutions to its customers, starting with development and production of active in-gredients and continuing in intermediate stages right through to complex dosage forms and products from its own portfolio.
Evonik Industries currently has 11 applications and service labs in all of the world’s major pharmaceutical markets, giving the company the capability to provide a comprehensive range of formulation development services for drugs designed for oral or parenteral admin-istration. The company claims that the labs are outfitted with leading-edge technology and infrastructure for formulation development and staffed by teams of experienced experts. Evonik produces a broad range of basic pharmaceutical products for a variety of medical challenges and applications.
Outlook
In the field of medicine alone, effective medication is available for only a third of all known illnesses. In addition, development of orphan drugs (drugs for rare medical conditions) is still in its infancy. The need for efficient formulation development techniques in the pharma-ceutical industry creates a wealth of opportunities for everyone involved. For cost reasons, short development cycles are becoming increasingly important in new development and product development in the chemical and biotechnology industries, and advances in formu-lation development produce significant benefits. Potenzial customers can explore a wide range of technologies and services at ACHEMA 2015 in the exhibition group “Laboratory and Analytical Techniques”, located in Hall 4.
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ACHEMA Trend Reports are compiled by specialized international journalists. DECHEMA is not liable for incomplete or inaccurate information. ACHEMA Trend Reports can be used for editorial purposes free of charge; the source has to be named (more details on www.achema.de)