BPI White Papers

Polishing of Monoclonal Antibodies Using Capto™ adhere ImpRes in Bind and Elute Mode

MAbs and MAb conjugates are today in great demand for use as biopharamaceuticals. As a result, more cost-effective, efficient, and flexible process purification schemes are one of the highest priorities for MAb manufacturers. In this work, results from two case studies using Capto adhere ImpRes, a multimodal anion exchanger designed for polishing, are presented. Two different MAbs were purified in bind and elute mode. The results show high yields of MAb monomers, good clearance of aggregates, HCP, and leached protein…

Going Paperless from Lab to Plant

The drive to “go paperless” is a strategic initiative that offers demonstrable operational benefits in improving productivity, reducing cycle times and leveraging experimental and operational data along the entire research-development-manufacturing continuum. This technology brief reviews recent initiatives by science-based organizations to develop and deploy software that spans the lab-to-commercialization lifecycle using data standardization/harmonization technology and electronic lab notebooks (ELNs) to streamline technology transfer. Organizations adopting these proven informatics solutions can experience: Enhanced productivity Faster time to market Improved compliance More…

The “early health” Vision

New approaches to vaccine production are needed. GE Healthcare Life Sciences contributes to the “early health” vision by supporting advances in vaccine development through innovative manufacturing solutions that help to shorten time-to-market, increase output, and assure quality.

Production of CGMP-Grade Lentiviral Vectors

Lentiviral vectors are important tools for gene transfer because of their ability to transduce a number of cell types without the need for host cells to be dividing. As a result, investigators are using them as gene delivery vehicles in clinical applications. Since lentiviral vectors play such a vital role in gene therapy, they need to be manufactured at large scale for clinical trials. But, large-scale production using CGMP methods can present a number of challenges.

To address these challenges, the authors of this case study developed a process that allows for extensive scale-up in a safe, sterile, and reproducible system to produce clinical-grade lentivirus. This manufacturing process is very efficient and can be carried out using minimal staff (two operators for production of each subbatch). It provides the extensive scale-up capacity necessary to produce CGMP-grade lentivirus, and it has been used successfully in several completed and on-going phase 1–2 ex-vivo gene therapy clinical trials.

Meeting Increased Demands on Cell-Based Processes By Using Defined Media Supplements

As the demand for cell-derived products is rapidly increasing, there are huge pressures on the biomanufacturing industry’s production capacity requirements. To keep up with this demand, more focus is being put into media development strategies for optimizing output from cell culture systems. Serum-based media have traditionally been used to address the individual nutrient requirements of animal cells used in manufacturing protein products, but are now being gradually phased out due to inconsistencies and potential contamination risk.

These factors have created a demand for development of serum-free media that deliver optimal cell growth and productivity. This white paper looks at the challenges facing biopharmaceutical manufacturers today and the role of defined media supplements in addressing those.

Streamlining Downstream Process Development

Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. But determining the most effective media type and area can be time consuming, labor intensive, and complicated because of a lack of specialized laboratory-scale equipment.

The equipment commonly used in this evaluation presents several disadvantages, including poor integration of multiple components from different sources (including pressure sensors, signal conditioning, data acquisition, balances, and pumps), continuous operator monitoring, and decreased portability of most systems due to their numerous components. This white paper describes how Genentech Inc. and PendoTECH collaborated on developing an integrated filter-sizing system that addresses these challenges and aids in efficient evaluation of filter media for manufacturing-scale processes.

Modeling Perfusion Processes in Biopharmaceutical Production

Biopharmaceutical manufacturing is mostly batch-based for a number of reasons: lower perceived contamination risks, batch-to-batch segregation, and historical legacy. Despite those reasons, perfusion is used by a number of biomanufacturers because it produces large product quantities using smaller bioreactors than would be possible with batch-based production.

Though perfusion-based production presents challenges that confound traditional models, it can create an environment in which many more factors can be influenced to directly optimize production. Read this case study to learn more about how perfusion can be used to create flexible, “just-in-time” facilities that respond to manufacturing conditions.

Integrity Systems: A Comprehensive Toolkit for Single-Use Solutions

Single-use solutions are in growing demand within the biopharmaceutical manufacturing industry. With a complete line of solutions — from mixing systems to ultra-clean packaging — ATMI LifeSciences is a leader in these technologies. In this educational webcast, Jared Hisle, Global Product Manager at ATMI LifeSciences, explores the full line of Integrity™ Systems single-use technologies, including:

• NewForm™ Sterilizable Packaging
• Integrity™ Liquid and Powder Vessels
• Integrity™ Mixers
• Integrity™ Bioreactors

ATMI maintains the world’s largest installed base of single-use mixing systems and offers the world’s only single-use platform including film extrusion. Join Hisle as he demonstrates the advantages of ATMI’s single-use solutions.