5
Outsourcing the entire column packing process is an alternative solution to the key challenges in column packing, with the end user receiving a ready-to-use column. Outsourcing has the potential to free resources and improve process productivity and throughput, and may be the more appropriate choice for when vendor’s do not have a prepacked option.
However, purchasing prepacked columns from vendors still ultimately presents the best solution to onsite packing challenges, due to the following:
• The vendor would have the best knowledge of the resin and column packing conditions - as such, optimal resin packing conditions would be used to pack columns to provide the best possible performance
• A prepacked column offered by the vendor would be its own product, streamlining the ordering process
• The vendor does not rely on an additional service or supplier to provide the resin, eliminating potential delays in resin availability and reducing the number of parties involved
• With the vendor, there would be the single point of contact, for ordering, technical and commercial support — this eliminates the need for the end-user to work with two different companies (i.e., when ordering a resin, and then requesting a packing service)
• The vendor would have the prepacked columns available in a shorter lead time or, in some cases, already available in stock, increasing process throughput by reducing potential schedule delays resulting from column availability
Regulatory Requirements for Prepacked Columns
Prepacked chromatography columns used for the production of biopharmaceuticals are subject to regulatory requirements designed to ensure the quality, safety, and effi cacy of these products. The regulations for prepacked chromatography columns vary depending on the country and the intended use of the columns. For example, in the United States, the Food and Drug Administration (FDA) requires that biopharmaceutical products must be manufactured in compliance with GMPs, designed to guarantee that products are produced in a controlled environment using standardised processes. The FDA also requires that biopharmaceuticals be tested and validated to ensure their quality and purity. In addition, prepacked chromatography columns used in biopharmaceutical production must be validated
to ensure their reliability and consistency, including validation of their packing, performance, and compatibility with the target molecule.
GMP prepacked columns offering a variety of column diameters, bed heights and resins to choose from, such as the Foresight and Foresight Pro columns, can support DSP chromatography applications across multiple stages of biological drug development and manufacturing [5]. This includes a wide variety of purifi cation and polishing applications for vaccines, monoclonal antibodies, and recombinant proteins.
Conclusions
The biopharmaceutical industry is continuously exploring new and innovative methods to streamline the purifi cation process and increase effi ciency. One such method is the use of prepacked columns which are becoming increasingly mainstream in DSP.
Prepacked columns enable streamlined, easy to scale-up purifi cation processes, with a better use of resources and improved throughput, which are critical for biopharmaceutical production. Moreover, they reduce the risk of column-to-column variability and provide a consistent and reliable purifi cation outcome, contributing to the quality and consistency of the fi nal biopharmaceutical product.
References:
1. Pre-packed Chromatography Columns Market,
https://www.datamintelligence.com/ research-report/pre-packed-chromatography-columns-market
2. He X et al, Purifi cation of Antibodies with Nuvia aPrime 4A Hydrophobic Anion Exchange Resin,
https://www.bio-rad.com/webroot/web/pdf/lsr/literature/Bulletin_7193.pdf
3. Prentice J et al (2020) Pressure-Flow experiments, packing, and modeling for scale-up of a mixed mode chromatography column for biopharmaceutical manufacturing. Journal of Chromatography A. 1625.
doi.org/10.1016/j.chroma.2020.461117
4. Langer E (2014) Innovation in Pre-Packed Disposable Chromatography Columns,
https://www.biopharminternational.com/view/innovation-pre-packed-disposable- chromatography-columns
5. Foresight Pro Columns – Process-Scale Prepacked Chromatography Columns, https://
www.bio-rad.com/sites/default/fi les/2022-05/Bulletin_3325.pdf
Read, Share and Comment on this Article, visit:
www.labmate-online.com/article New GPC/SEC Combination Detector
Testa Analytical Introduces an advanced detector package combining Multiple Angle Light Scattering and Differential Refractive Index (MALS/DRI) for more demanding Gel Permeation Chromatography (GPC/SEC) Applications.
MALS is a reliable detection technique for GPC/SEC that delivers precise molecular weight data for a range of molecules, from small to large. It has proven to be effective in polymer, protein, and polysaccharide applications, earning a reputation as a trusted method.
To achieve the highest level of accuracy and sensitivity, it is necessary to combine MALS with a DRI detector. The DRI detector is specifi cally designed to provide concentration information that is detected at the same wavelength as MALS, resulting in more precise and sensitive results.
Testa Analytical has introduced the new COMBO-TWO MALS/DRI detector package, which combines a high-performance 7-angle MALS and an ultra-stable DRI detector that operate optimally with an integral 640nm light source. This perfectly matched combination offers exceptional results with the lowest possible delay volume between the MALS and DRI detectors. The unique COMBO-TWO is fully compatible with all commercial GPC/SEC systems and has high thermal stability, operating from room temperature up to 80°C. Obtaining highly accurate and reliable MALS and DRI data is easy - simply inject your sample into the low-volume fl ow cell.
More information online:
ilmt.co/PL/9RGD 59915pr@reply-direct.com
Space Saving PEEK HPLC Tubing
Save space and maintain good chromatography when distance is required between your HPLC components and columns. FlexiTubes™ from Microsolv Technology are fl exible length, coiled PEEK tubing that will expand and contract like a phone cord, saving space and allowing distance without causing band broadening since it is a pulse dampener. Also great for organising your -instrument and eliminating that cluttered look.
The FlexiTubes™ will provide a pulse-dampener effect for parabolic fl ow fl uids, which will result in a quieter base line and reduce band broadening. Now at reduced prices and increased selection.
More information online:
ilmt.co/PL/2PEJ 59568pr@reply-direct.com
Send your Press Releases to:
pr@intlabmate.com
WWW.LABMATE-ONLINE.COM
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56
