"Out of the Box" Process Development
The PDReady™ for Monoclonal Antibodies (MAbs) Kit provides the tools required for rapid and efficient process development for all unit operations from clarification to bulk drug substance.
PDReady™ for MAbs Template
Acceleration of PD activities
The PDReady for MAbs Kit is designed to accelerate process development for a monoclonal antibody. This is accomplished three ways:
- Pre-defined MAb purification template based on technologies proven for IgG1 sub-types monoclonal antibodies produced in CHO cells.
- Pre-selected parameters and conditions for each unit operation to simplify process development work. Each unit operation uses a state-of-the-art product that is already a part of many monoclonal antibody processes.
- Protocols and equipment are provided in order to ensure minimum hassle while yielding maximum results.
A Complete Offering
- Devices: From small-scale to intermediate devices – we provide all of the purification products necessary to develop your downstream process for the purification of a monoclonal antibody. These products have proven robustness
and scalability all the way up to the commercial scale. The devices are sized to work with bioreactors from approximately 1 L to 10 L and a wide range of protein titers.
- Protocols: Our precise protocols are designed for each unit operation and used to guide process development. Protocols focus on generating robust scale-down data, while minimizing the amount of experimental work required.
- Equipment: The PDReady™ for MAbs Kit includes calibrated, state-of-the-art hardware. This equipment is lent to the customer for the length of the process development activity.
Note : Options for a bench-top chromatography system are available as an additional offering.
- Lab essentials recommendations: Several pieces of general laboratory equipment such as tubing, connectors and other small accessories are needed to execute process development activities. The PDReady™ for Mabs Kit includes specific recommendations for each part that needs to be ordered to successfully execute the protocols.
- Consultative support: Support from our technical experts for experimental design, data analysis and scale-up recommendations is included.
What happens next?
The template is designed for convenient scaling to a clinical process using primarily single-use separation devices and pre-packed columns as well as a single-use flow path, designed to be operated with our innovative Mobius FlexReady Solutions. Alternatively the process can be scaled just as easily to a stainless steel based process if required.