GEA Pharma Systems at the AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing

The AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing will take place at Sheraton Inner Harbor Hotel, Baltimore MD on September 20 and 21, 2010. At this event GEA Pharma Systems will introduce the Collette table top continuous granulator.

About the Event (from http://www.aapspharmaceutica.com/meetings/workshops/DPM/index.asp)

With the establishment of the new Manufacturing Science and Engineering section at AAPS, an annual two to three day themed conference devoted to various aspects of pharmaceutical /biotechnology manufacturing, packaging, engineering and quality is envisioned to be held every year. The conference in 2010 is the first in the series and will be focused on reviewing advances and opportunities in drug product manufacturing with a special focus on continuous manufacturing. While drug product manufacturing has been discussed in various workshops/conferences they have not focused on examples and practical applications of continuous manufacturing, advances in process control, and various approaches for managing risks to product quality throughout the product life cycle. ...... We hope that the attendees will also be able to:

• gain knowledge about the continuous manufacturing process,
• determine the advantages of continuous manufacturing and application of QbD and PAT concepts,
• get a perspective on 'Real Time Release Testing' from companies who are well into such techniques and learn from regulatory bodies their experience of reviewing such applications,
• gain insight into implementation of quality risk management strategies throughout the product life cycle, e.g. Continuous Verification.

GEA Pharma Systems and Continuous Processing

GEA Pharma Systems is on the forefront of the continuous solid dosage manufacturing development and pioneered the ConsiGmaT - the continuous oral solid dosage tablet manufacturing is designed for 'plug flow', first-in first-out, avoiding back mixing, providing a consistent quality and allowing for control of critical quality attributes in-line.

Continuous tablet manufacturing allows the pharmaceutical industry to bring products to the market faster, in a more flexible and environmentally conscious way.

• No process scale-up as time is the only relevant factor in a continuous process
• Dramatically reduce development time and costs
• The system is compact (1/3 of a classic granulation line)
• Modular construction - fits perfectly into any R&D department or existing Solid Dosage suite (inclusive of a tablet press)
• Quality by Design (QbD) philosophy

No more products in quarantine, no more sampling, no more rejects, no more scale-up, Just-In-Time production: COST REDUCTION

• Continuous high shear granulation and drying leads the way to a risk based approach and lean manufacturing.
• Process know-how and control on a micro-scale results in guaranteed quality, avoiding end of line testing and allowing for parametric product release.
• Full flexibility in batch size (simply by adjusting the time of production) enables you to produce your products to meet demand, producing exactly the quantity you need, while keeping your expensive clean room space reduced to a minimum.

ConsigmaT reduces time to market of new medicines.

• The operating principle of ConsigmaT allows you to explore the design space of the process within days instead of weeks, thereby reducing development time and cost significantly.
• The same machine can manufacture your development, pilot, clinical and production batches, simply by running for a longer time. This avoids lengthy and costly validation and process scale-up efforts, helping to bring your products to the market much faster.

A small machine delivering maximum output with minimal utilities in a continuous way.

• No peak consumptions, reduced space requirement, smaller buildings, smaller clean rooms. All these advantages lead to less consumption of the precious resources of our earth.
• ConsigmaT is also equipped with an advanced process control system resulting in guaranteed quality results and avoiding the generation of toxic waste.

Finally, the machine is contained to protect the operator and environment and prepared for production of molecules for decades to come.