Training Courses

FAH Course 2020: plant based extracts - process development and production

Plant-based extracts are used on an industrial scale for the production of phytopharmaceuticals, food supplements and cosmetics. Current trends such as "natural products" and "...away from fossil fuels" are strengthening the growth of these industries.In comparison, the technology used for the production of extracts does not reflect the latest state of knowledge. In order to maintain the current markets and win new ones, even against the background of increasing regulatory requirements, a considerable improvement in technology is required. This improvement is based on the further development of basic processes and equipment as well as the application of process design methodology based on simulation and laboratory experiments.

Date: 18th. - 21st. October 2020

Further Information (Flyer)

FAH Website

Past Courses

FAH Course 2019: Phytoextraction

Date: 13th - 16th October 2019

Further Informations

PDA Course: Accelerating Biomanufacturing by Modelling

Innovative biologics, including cell therapeutics, VLPs, exosomes, recombinant proteins, peptides etc. seem to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a general change of methods as well as mindset in the process development stage as there are no platform processes available like for mabs.

Moreover, market competitiveness demands hyper-intensified processes, including accelerated decisions toward batch- or continuous operation of dedicated modular plant concepts. This indicates gaps in process comprehension, when operation windows need to be run at the edges of optimization.

In this trainings course potential methods are demonstrated for possible solutions throughout the workflow from process development over piloting towards manufacturing operation from process engineering point of view and experience. Especially, the state-of-art for modelling in biologics manufacturing is assessed, clarifying differences and application of statistical, rigorous physical-chemical based models as well as cost modelling. “Digital-twins” are described and efforts vs. benefits for new applications exemplified including the regulatory demanded QbD-(quality by design) and PAT-(process analytical technology)-approaches towards digitalization or industry 4.0 based on advanced process control strategies. Finally, an analysis of obstacles and possible solutions for any successful and efficient industrialization of innovative methods from process development over piloting towards manufacturing, operation, robustness, and analysis results in some recommendations. A central question is exemplified: Under the mindset of QbD and PAT demanded by authorities since 2004, could any biologics manufacturing process be regulatory approved without being modelled by a digital-twin as part of the filing documentation?

Date: 15th - 18th September 2019

Further Informations

PDA Traning Course 2018: Process Chromatography

Current developments in the field of stationary phases as well as new insights in the process design through simulations, combined with laboratory experiments and / or statistical experimental design, have led to the fact that the process chromatography increasingly represents an economical process alternative, both in product development and in production. The separation of isomers, enantiomers and diastereomers as well as the processing of phytoextracts and fermentation broth are typical applications.

The course content is taught in the form of lectures, interactive tutorials, group experiments in the laboratory and simulations on the computer. The target group are scientists and technicians involved in preparative chromatography on a process and production scale, as well as chemists and engineers in process development.

Date: 14.-17. October 2018

Further Informations

PDA Course 2018: DSP- Purification of Biomolecules

In manufacturing of bio-molecules often 50-90 % of the Cost of Goods (COG) are caused by Downstream Processing (DSP). In process development separation processes must be proposed in an efficient sequence based on physico-chemical properties of target molecules, contaminants, side components and impurities to increase yield/recovery.

In this course the design of unit operations like ultrafiltration / diafiltration (UF/DF), ion exchange- and affinity-membranes as well as affinity, ion exchange (IEX), immobilized metal affinity (IMAC), size exclusion (SEC), hydrophobic interaction (HIC) and reversed phase chromatography is presented and explained. These are established key-technologies which are highly efficient and broadly used in manufacturing. Additionally, protein refolding, extraction and precipitation/crystallization are discussed. Moreover, methods for virus inactivation and clearance are explained.

Date: February 25.-28, 2018

Further Informations

PDA Kurs 2018: CPB - Continuous Bioprocessing of Biomolecules

For synthetic APIs, increasing attempts to move from traditional batch to continuous manufacturing are ongoing. Advantages are in particular higher product safety by enhanced process robustness, smaller foot print of the plants, lower cleaning costs and down-times due to dedicated modular and flexible plants.

For the production of biopharmaceuticals, e.g. monoclonal antibodies, fermentation is already more often used in a continuous perfusion mode than is known to the public. Therefore, it is only consistent to apply continuous process concepts also for downstream processing operations. In manufacturing of biomolecules these concepts have so far only been applied for high-volume bulk or fine chemicals. However, with the upcoming cost issues in the manufacturing of biotherapeutics by low cost biogeneric manufacturers and stratified medicine scenarios, first approaches to industrialize continuous manufacturing for biologics like amino acids, peptides, proteins and monoclonal antibodies and fragments, are under investigation

The course will describe the design and scheduling of unit operations in continuous manufacturing processes in contrast to classical batch operations and aims at providing viable decision criteria.

Termin: February 27.- March 01, 2018

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