Industry Insights

  1. Single-Use Extractables and Leachables: Alignment with the BPOG Protocol

    Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.

  2. The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  3. GE Works On Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.

  4. Advantages of Multidimensional (Multi-D) Chromatography —What’s it all about

    The need for companies to shorten their development or manufacturing time means that process development must be fast and inexpensive without compromising the quality of the end product. To address this challenge, many companies are moving towards automation.

  5. Keeping Your Cool When Storing Purified Protein

    The study of proteins and their function is central to understanding biology, but separating and purifying single proteins from complex mixtures is hard work. After investing the time to purify your target protein using various chromatography methods, losing your protein integrity because of improper storage would be devastating. Good storage conditions are particularly important if you need your protein for several downstream studies. You might need to store your preparation for an extended period of time, and some experiments require that the protein retain its original structure, binding affinity or enzymatic activity. Here we discuss some quick and simple suggestions relating to concentration, additives, sample size and storage temperature to consider when storing your protein for future use.

  6. Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.

  7. Purification Of Recombinant F(Ab’)2 Fragments And Their Various Applications

    Fragment antigen binding domains, or F(ab) fragments, are derived from the upper branches of the ‘Y’-shaped antibody molecule. They form the antigen binding interfaces of intact antibodies, known as the paratope, and retain their inherent target binding capacities even when isolated from the rest of the protein (the Fragment crystallizable or Fc fragment). Separation can be achieved enzymatically using an either papain or pepsin. Cleavage with papain yields two individual F(ab) fragments consisting of a single light chain and half of a heavy chain (comprising a VH and CH1 region), whereas cleavage with pepsin produces F(ab’)2 — two individual F(ab) fragments joined together by a disulfide bond. Additionally, modern molecular biology techniques have enabled the genetic engineering and production of F(ab) fragments in host cell systems, allowing them to be expressed independently of the Fc region without the need for enzymatic cleavage and permitting an array of different conformations.

  8. Overcoming Purification Hurdles With Mixed-Mode Chromatography

    Current production systems can generate high titers of adenovirus, however, adenoviral vectors are tricky to purify on any significant scale despite their availability and abundance.

  9. Useful Tips For Fab Protein Purification

    While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets. This makes a lot of sense as proteins come in many different sizes, structures and possess unique binding affinities and biological activities. As such, it’s not surprising that specific proteins require purification strategies tailored to their own unique physico-chemical properties.

  10. Simple Steps To Maintaining Your Chromatography System

    Chromatography is one of the essential techniques used for the separation, identification, purification and quantification of components from a heterogenous solution. The instruments behind these techniques are often considered the “work horse” of the lab so keeping your system up and running is a must if you want your experiments to work. Although these instruments can seem daunting with all of the tubing and valves, there are simple and straightforward maintenance tips involving sample preparation, buffers, columns and the overall system to keep your experiments humming along.