Modular Bioprocessing

The world of bioprocessing is changing.

With an increased demand for biologics, small-batch personalised treatments, rising new modalities, and of course the need to bring drugs to market quickly. And all of this among increasing pressure to reduce the cost of both development and manufacture, to allow drugs and therapies to become more accessible to a broader segment of the global patient population.

While having met the needs of large-scale processing for many years, traditional facilities with fixed, inflexible production equipment now lack the adaptability needed to accommodate the accelerating change.

However, systems designed with a modular philosophy are able to embrace adaptability through that configurability. They're a collection of units which can be constructed into a more complex arrangement - each unit having the ability to be adapted to the procedure itself, such as the modification of flow for an optimal, more controlled outcome.

Modular bioprocessing systems facilitate solutions that deliver the same process agility for all manufacturing processes, achieving new levels of control for performance, scalability and productivity, while adhering to all cGMP standards.

Our Allegro^™ Connect system family enables you to adapt pre-engineered, pre-validated modular bioprocessing systems to suit your individual process needs. These systems can be combined to create a standardized process, which with the right configuration, can meet the individual requirements.

The Future is Modular … The Future is Allegro™ Connect Systems

Existing manual processes can cause an increase in non-recoverable volume, prevent flexibility and cause valuable data to end up scattered across many different software platforms.

As a result, this typically increases the amount of operator and management time required, the amount of operator-introduced errors, increased amount of time and money spent, wasteful data mining, a loss of valuable drug product doses, and limitations on optimal process designs.

Allegro™ Connect Systems are ideal for modular biomanufacturing and will seamlessly integrate into your facility, reducing the risk of operator error and batch failure, thanks to a fully- automated process, including a manifold leak test and filter integrity tests.

Productivity is also significantly increased, with greatly-reduced labour per unit operation. Pre-configured systems provide enhanced process flexibility for a range of batch scales (from 200 to 2000 liters).

The integrated batch report and harmonized data management also provides simple data mining, enabling you and your operators to spend less time collating data, and more time optimizing your process.

Problem	Effect	Solutions provided by Allegro Connect Systems	Benefit
Large amounts of manual processing	Unwanted, unnecessary processing time wasted Increased levels of operator time and error	Seamless (modular automation configuration) system integration into your processes Fully-automated processing, including manifold leak test and filter integrity tests	Significantly-reduced processing time Reduced risk of operator error/batch failure, increased productivity, reduced operator per unit operation
Non-recoverable product volume	Loss of highly-valuable drug product doses	Novel recovery method dedicated to bulk fill system efficiently recovers product from filters and flowpaths	Improved efficiency, minimizes non-recoverable product volume
Lack of flexibility	Limited process design ability	Pre-configured systems	Maximized configurability, maximized usability, maximized productivity and enhanced process flexibility for a range of process streams
Data scattered across various software platforms	Tedious data mining	Integrated batch reporting and harmonized data management	Significantly improved data handling and reporting

Allegro™ Connect Buffer Management System

Providing just in time buffer delivery for unit operations, by in-line dilution of concentrates at point of use. The improvement in product titers and process intensification increases the number and volume of process buffers required.

This in-line dilution system has been designed to meet increasing process demands by enabling savings on floorspace and APEX expenditure and delivers a reduction in overall buffer cost per liter compared to buffers made in-house.

Allegro™ Connect Bulk Fill System

An automated, configurable platform to filter and accurately aliquot bulk drug substance. This system can fill up to 320 biocontainer bags or bottles, ranging from 1 to 20 liters.

With its compact single-use flow path, the system achieves significantly low non-recoverable volume for high value bulk drug substances.

Allegro™ Connect Depth Filtration System

A single-use automated filtration system designed to deliver robust process control during the clarification/harvest step.

With its standard single-use flow path and liquid filter configuration, the system can fit process volumes from 200 liter (pilot) to 2000 liter (production) scale.

Allegro™ Connect Virus Filtration System

An automated and configurable platform, designed for virus filtration and other in-process intermediate filtration steps.

With standard single-use flow path and flexible filter options, this system can adapt to accommodate the process stream from bioreactors from 200 liters to 2000 liters.