Backgrounder: Pall Leads the Paradigm Shift in Disposable Biopharmaceutical Processing

The biopharmaceutical industry has embraced disposable products since their advent in the 1970s. First introduced for small lab scale applications, disposable technologies have since become available for almost every aspect of biopharmaceutical drug processing.

Today, the impetus for adopting disposable technologies is not only improved cost and safety, but also the unique process optimization benefits they offer.  An increasing number and range of single-use product options have made it easier for biopharmaceutical companies to apply disposable methods across the full spectrum of their manufacturing process.

Fueled by the need for faster processing times from development to production and a quality assurance requirement for straightforward and simplified cleaning validation, the move to disposable processing is one of the latest paradigm shifts to safely and efficiently speed up the development and production of drug therapies and vaccines.

Benefits of Disposable Systems
Pre-assembled, pre-sterilized systems provide a number of benefits in manufacturing operations. 

Streamlines operations especially in the early stages of drug development. Scale-down disposable products make it easier for researchers to evaluate performance.  Instead of having to put together filtration or separation products into appropriate assemblies, the products are supplied in a ready-to-use format. In addition, since the same materials of construction are used from lab to pilot to process scale, materials validation is simplified. 

Eliminates certain validation operations: cleaning validation, sterilization validation and decreases documentation requirements. Disposable systems decrease time/labor costs as the manufacturer provides documentation for all system components. Pre-sterilized assemblies eliminate autoclave and steam-in-place process validation needs. Cleaning validation is also eliminated or significantly reduced, since the systems are used once and discarded.

Reduces time during manufacturing. Systems are pre-assembled and pre-sterilized; therefore, timesavings are achieved throughout the production process, from initial assembly to disassembly post-use. In situ or autoclave sterilization can be eliminated completely from process steps, which saves time and also reduces or eliminates maintenance required for steaming equipment.  Additionally, time between manufacturing campaigns is decreased.

Saves money. Since disposable systems do not require cleaning, the cost of cleaning chemicals as well as water for injection is reduced.  In addition, the cost of steam is reduced for pre-sterilized operations.

Improves safety. Increased personnel safety as operator intervention is significantly reduced. Decreased operator exposure to product, especially in critical for cytotoxic biologicals.  Eliminates working with corrosive chemicals during CIP operations. Also, disposable components are typically lighter than equivalents used in hard piped systems, making operator handling easier and safer.

Provides flexibility. Greater flexibility in terms of system size. System upgrades as newer technologies become available are feasible. It is also easy to add capacity with disposable components. For example, it is easy to manifold a series of bags or capsules. The equivalent additions in a hard-piped system would involve welding a new tank or filter housing into the system.

Small footprint optimizes available space. Single use systems generally have a smaller footprint than hard-piped systems. For facilities with limited space, single use systems can be used to maximize available space.

Visible process fluids. Many disposable components are transparent or translucent. This enables operators to see the fluid during the process to confirm flow as well as the end of an operation.

Eliminates cross contamination.  Disposable systems are ideal for contract manufacturers as well as patient-specific drugs and vaccines, since cross contamination issues are eliminated wherever single use systems are used.

Pall’s Line of Disposable Products and Applications

Application Disposable Solution
Buffers/Media Mini Kleenpak™, Kleenpak, Kleenpak Nova and NovaSip™ capsules with Supor® EKV membranes
Low Protein Adsorption Mini Kleenpak, Kleenpak, Kleenpak Nova and NovaSip capsules with Supor EKV membranes
LVP/SVP(Large and Small Volume Parenterals) Mini Kleenpak, Kleenpak, Kleenpak Nova and NovaSip capsules with Ultipor® N66 or Fluorodyne® II membranes
Serum Mini Kleenpak, Kleenpak, Kleenpak Nova and NovaSip capsules with Fluorodyne II DJLP 0.1 micron membranes
Contaminant Removal (DNA, Host Cell Proteins, Viruses, Endotoxins) Mustang® Q, Q XT, or S Chromatography capsules
Capture (Plasmids, Viruses, Proteins) Mustang Q or Q XT Chromatography capsules
Viral Clearance(Blood Products or Derivatives, Recombinant Proteins, Monoclonal Antibodies) Kleenpak Nova and NovaSip capsules with Ultipor VF virus removal membranes
Depth Filtration Supracap™ 60 and 200 capsules
Pre-Filtration Kleenpak Nova and NovaSip  capsules with PreFlow™, Profile® and HDC® II membranes
Tangential Flow Filtration Centrasette™ P holder and disposable system
Air/Vent Mini Kleenpak and Kleenpak capsules with Emflon® II membranes
Connections Kleenpak connector