Industry Yearbook 2014-2015

Single-Use Approaches to Powder Transfer: Facing the Challenges

Media and buffer preparation is a key part of the biopharmaceutical manufacturing process. Although this step doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes preparation cleaner, safer, and more efficient while protecting personnel and cutting time and costs. The Issues of Powder Handling Powder ingredients for media and buffers have historically been transferred using scoops and weighed and mixed in buckets or open top bags. Many companies are starting to move to single-use…

Scale-Up of Plant Cell Suspension-Based Processes

In the field of research and development into the production of bioactive compounds, there is incredible demand for small-scale cultivation systems that operate in the liter range (1, 2). Single-use bag bioreactors can close the gap between cell and media screening devices (at scales of up to several hundreds of milliliters) and pilot bioreactor systems at scales larger than several hundreds of liters (3). The incubator shaker Multitron Cell with ShakerBag Option, in particular, represents an easy and economical solution…

Enhanced Assurance of Supply for Single-Use Bags: New Flexsafe Bag Family

Growing adoption of single-use bags for the production of biopharmaceutical drugs raises new challenges, including consistent product quality, improved assurance of supply, robust change management, and business continuity planning. In close collaboration with resin and film suppliers, Sartorius Stedim Biotech’s polymer scientists and biologists have followed a quality by design (QbD) program for the development of a completely new polyethylene film S80 thus achieving consistent performance of the new Flexsafe bags for all bioprocess steps and applications. The partnerships and…

Modular System Design Supports Lean Manufacturing: The Role of Sterile Connectors in Modular Systems

No longer is the biopharmaceutical industry questioning whether it should use single-use technology. The focus has transitioned to how to best implement single-use systems. Rapid adoption of single-use systems has brought added complexity; which is leading to an increasing application of lean manufacturing principles. Standardization projects and establishing appropriate standards are current trends that drive toward reducing the complexity of bioprocessing systems, from design and validation to supply chain and manufacturing integration. Although efforts are underway to develop consensus standards…

pDADMAC Flocculant Reagent for Use with ClarisolveĀ® Depth Filters

Advances in cell line engineering and media design have allowed for improvements in monoclonal antibody expression, with cell culture systems exhibiting product titers >10 g/L. These high-density cell cultures pose a great challenge in the use of existing solid liquid separation techniques because of the need to remove larger amounts of biomass and the increase in submicron particles. In addition, the increased level of soluble impurities introduces new bottlenecks for chromatographic processing because of the increased levels of contaminants from…

High-Capacity Protein A Chromatography Medium for MAb Capture from High-Titer Feeds

As product titers continue to increase in upstream cell culture processes, so too the demand for enhanced capacity in downstream purification steps. MabSelect SuRe LX chromatography medium (resin) is specially developed for monoclonal antibody (MAb) capture from high-titer feeds. To help ensure good process economy, the medium can withstand hundreds of rigorous cleaning cycles with NaOH, with retained dynamic binding capacity (DBC) and MAb yield. High Dynamic Binding Capacity (DBC) Large-scale purification of MAbs usually consists of two or three…

Removal of Antibody Aggregates Using Cellufine MAX GS

Purification of therapeutic monoclonal antibodies (MAbs) requires advanced and selective means for separating aggregates from target monomers. Cellufine MAX GS chromatography media are optimized for higher capacity, better separation, and greater selectivity to improve downstream purification of MAbs. JNC Corporation’s new strong cation exchanger, Cellufine MAX GS, has optimized ligand density for improved dynamic binding capacity and selectivity and superior pressure flow characteristics, which are required by MAb purification platforms. MAb Monomer/Aggregates Separation: Cellufine MAX GS exhibits exceptional selectivity between…

Purification of Monoclonal Antibodies Using Kaneka KanCapA

Industrial-scale production of pure monoclonal antibodies (MAbs) customers require an overall highly efficient affinity resin with a high binding capacity, high alkaline stability, good elution profile, low nonspecific binding, and large-scale column operation. Kaneka has developed a novel protein A ligand and immobilized it to highly cross-linked cellulose beads to totally satisfy all these requirements. Here, we demonstrate the performances of the Kaneka KanCapA using MAbs. Mild pH Elution and High-Binding Capacity: The elution profile of a protein A column…

LEWA EcoPrimeĀ®: The Next Plateau in Control, Accuracy, and Reproducibility in Preparative Chromatography Systems

The LEWA EcoPrimeĀ® LPLC chromatography platform combines proprietary fluid design and the LEWA IntellidriveĀ® technology to deliver unrivaled batch-to-batch reproducibility and accuracy. The LEWA EcoPrimeĀ® features our open architecture automation software and is built on a quality control of the industry’s most vertical supply chain. A single LEWA system has the range of up to three conventional LPLC units while providing a higher level of accuracy. This gives the user great flexibility, more floor space, and plant-friendly integration with simple…

High-Capacity, Single-Use, Strong Anion-Exchange (Q) Chromatography Tools: Speed and Process Flexibility for MAb Purification

Strong anion-exchange (Q) chromatography is an industry standard for polishing purification steps of monoclonal antibody (MAb) production. It is a proven technology that removes DNA, viruses, endotoxins, and acidic host-cell proteins (HCPs) from process feed streams in flow-through mode. Advancements in cell culture technology, the emergence of cost-sensitive biosimilars, and the limitations of conventional purification technologies have led to an industry-wide interest in downstream single-use technologies and more flexible biomanufacturing options. Despite their high binding capacity, traditional resin-based chromatography columns…