introducing One Step Selectivity-purification biological products

Innovative Downstream Cell Culture Products and Great Posters Featured at the Bioprocess International Conference – Part III


I have been covering innovative products that caught my eye at the Bioprocess International Conference in Boston and have included brief descriptions of some of the products featured this year. Below is Part III of my summary where I have focused on downstream products. I am hoping to follow up these brief descriptions with guest blogs to describe some of the products in more detail in the coming months.

Life Technologies’ CaptureSelect™Affinity Resins

Life Technologies’ presented an interesting poster on their CaptureSelect™ product titled “CaptureSelect™ Technology: Introducing One-step Selectivity in the Purification of Biological Products.” The poster describes how the CaptureSelect™ system provides a one step solution for direct capture purification of antibodies, antibody fragments, fusion proteins, and biosimilar hormones. This product line includes ready to use resins for small scale purification of antibodies, non-antibody proteins, and C-tag affinity tag system.

Benefits presented for CaptureSelect™ bioprocess-scale affinity resins include:

  • Increased selectivity – high purity in single step/feed stock independent
  • Mild elution conditions – retaining biological activity of target
  • Reduction in the number of process steps – helping increase yields, reduce costs
  • Efficient clearance of HCP, DNA and virus – high selectivity in capture step

In addition, Life Technologies offers custom ligand development and a line of companion products for characterization, quantification and detection. The poster includes data on FSH affinity resin, and human Fab fragments.

Repligen’s OPUS Pre-Packed Disposable Chromatography Columns

Repligen presented a very informative poster, titled “Implementing Disposable Chromatography: Technology Fit in Downstream Purification.” The poster looked at the use of OPUS™ columns by evaluating four key areas including: column size, chromatographic performance, economics, and documentation. I have provided a summary of each area below.

Column Size

  • OPUS™ offers nine different industry standard diameters and a range of bed heights to address both development or bench scale and GMP manufacturing scale.

Chromatographic Performance

  • Chromatographic performance is examined using purification of a recombinant protein from filtered cell lysate on OPUS™ packed with SP Sepharose for ten cycles. Then a multi-cycle test was conducted that recirculated the same OPUS column with high salt buffer for two weeks. Lastly, two additional cycles were completed with the OPUS™ packed with SP Sepharose. The results of the study were that the OPUS™ columns maintained packing quality attributes (plates/m, asymmetry, and pressure drop) and consistent purification results (yield, purity, and chromatography).

Economics

  • The economic advantages were evaluated by examining both time and cost savings.
    • Time savings were measured by evaluating five key functions and results showed that by using the OPUS™ columns about 75 hours could be saved in small scale clinical campaigns.
    • Cost savings were measured comparing five costs and results demonstrated an estimated $20,000 USD savings by using OPUS™ columns.

Documentation

  • A regulatory support file and certified certificate analysis come with each column.
  • OPUS™ columns are manufactured under a ISO9001:2008 certified quality management system.

ForteBio’s Optim™2 System

ForteBio featured their Optim™2 System for high throughput protein analysis and characterization in stability studies. The system is designed to reduce time and cost of pre-formulation studies, stability testing and formulation development of therapeutic proteins. The Optim™2 System uses simultaneous static light scattering and intrinsic fluorescence detection in a novel configuration, which allows for measurement of a range of protein stability-indicating parameters and rates of aggregation. This data can aid and facilitate decision-making earlier in drug development by identifying drug candidates with the best properties early.

Innovative features identified by ForteBio include:

  • Simultaneous fluorescence and light scattering analysis for label-free probing of protein unfolding and aggregation
  • Analysis of the effects of temperature, time and chemical environment on your biomolecule
  • Capability to analyze up to 48 temperature-controlled samples simultaneously
  • 144 samples measured in a high resolution thermal ramp per day
  • Best in class sample volumes: only 9 microliters per sample
  • Sealed sample chamber to enable high temperature analysis without evaporation
  • Easy-to use software with exceptional functionality and performance designed around the needs of the protein scientist

Natrix Separations’ NatriFlo™ HD-Q Membrane Adsorbers

Natrix Separations’ launched their new NatriFlo™ HD-Q Membrane Adsorbers at the Bioprocess International Conference. The NatriFlo™ HD-Q uses membrane technology that employs a three-dimensional macroporous hydrogel structure. The structure allows for a high density of binding sites and rapid mass transfer. As a result, they have reported high binding capacity and fast flow rates.

Natrix Separations has identified the following advantages:

  • Best-in-class HCP removal, DNA removal and viral clearance
  • Salt and pH tolerance in an industry-standard strong anion exchange (Q) chemistry
  • Simple, low cost polish operations in a single-use format

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