Top Downstream Process Articles of 2020

Don’t miss our top articles on downstream processing for 2020! I have compiled a list of our most popular articles from 2020 in alphabetical order.

Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint

Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers…

Cellulose Fiber-based Chromatography Increases Flexibility and Throughput in Antibody Purification

Recent industry initiatives have put increased emphasis on improving the flexibility and throughput of biomanufacturing processes. To achieve this, new technologies are required that permit faster process times and increased flexibility for a variety of manufacturing scenarios including smaller batch sizes and multi-product facilities. One critical aspect of the biomanufacturing process is downstream chromatography purification and this can often be a time and resource intensive step…

Combining Ion Exchange and Reverse Phase Chromatography for Highly Efficient and Cost Effective Peptide Purification

Therapeutic peptide purification can be very challenging because of the similarities between peptides and their impurities. There is not a significant difference in retention for the target peptide and a peptide contaminant that has one amino acid that is different. Thus, separation of peptides from by-products requires long retention times that are inefficient. In addition, even small changes in the mobile phase composition can cause significant effects. One way to increase the separating power of RP-HPLC is to make use of an ion-pairing agent, which couples with basic amino acids, resulting in a net zero charge. Generating a net zero charge status enables separation using a reverse phase process. However, the duel reverse phase process can be cost prohibitive for peptides that require a high level of purity…

Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance

Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…

Single-Use Tangential Flow Filtration (TFF) Offers Advantages for Viral Vectors and Vaccines

The advantages of single-use systems have been well documented in biomanufacturing for over a decade and are frequently used in the manufacture of monoclonal antibodies. Key areas where single-use systems provide real benefit over stainless steel counterparts is in reducing production change-over time and decreasing the cleaning and validation that requires significant time, labor, water and utility costs. Single-use systems also enable flexible facilities, require less capital investment and are quicker and easier to initiate than stainless steel facilities. These technologies are also often compatible with process automation. While certainly beneficial to monoclonal antibody production, there is even a more compelling case for using single-use technology in viral production, specifically for viral vectors and vaccine manufacturing, where even a small cross-contamination could be detrimental. Within viral production, one area where single-use can provide a significant benefit is in tangential flow filtration (TFF). TFF is frequently used during viral vector manufacturing to concentrate, exchange buffer and in final formulation. The compact system design also allows for low minimum recirculation volume for high concentration factors and product recovery…

Strategies for Increasing Productivity and Reducing Cost of Chromatography in mAb Biomanufacturing

Protein A has been the favorite choice for purification of mAbs for decades and there have been significant improvements since its first use. The selection of Protein A resins involve several factors relating to purification performance, these include productivity, buffer consumption, scalability, and process economy. In addition, new manufacturing strategies including continuous processing and hybrid options add additional criteria to selection. Every product and facility presents its own unique process challenges and constraints. One issue is the increasing use of high titer cell lines. While producing large amounts of product in upstream, these processes are challenging existing facilities designed for lower titer processes. Facilities must adapt to handling a significant increase in product and buffer volumes. Thus, the industry needs new chromatography strategies and technologies to provide flexible purification solutions that can address increasing titers and do so cost-effectively…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…

When to Choose Agarose or Methacrylic Polymer Resins– Frequently Asked Questions

Over the past decade we have seen an increase in the resin options available for chromatography. These new resins have different chemical compositions and molecules access them differently. Thus, they provide a more “fit for purpose” solution, especially for emerging therapeutics. While the increased choices are great for purification efficiency, it can sometimes be difficult to navigate the resins available, the different grades, and what each are best suited for. In an effort to clarify these resin choices and highlight two popular options, we talked to Dr. Alessandra Basso, Business Development Manager for the Lifetech™ and Chromalite® product ranges and Hans J. Johansson, Global Applications Director both at Purolite Life Sciences about the most frequently asked questions for resin selection between agarose and methacrylic and what each is best suited for…

 

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