Industry Insights

  1. Consultants’ Guide To Flexible Biomanufacturing Solutions

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.

  2. Expanding Single-Use Biomanufacturing Into New Locations

    If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.

  3. Biosimilar Developers Must Scale Mountains of Data

    The U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio).

  4. 6 Types Of Diseases Related To Endotoxins Of Gram-Negative Bacteria

    Almost any environment is appropriate for the development of Gram-negative bacteria, given that contamination with these bacteria is very common.

  5. Comparing Culture Methods In Monoclonal Antibody Production

    Recombinant protein manufacturing with Chinese hamster ovary (CHO) cells represents over 70% of the entire biopharmaceutical industry.  In fact, human monoclonal antibodies (hMAbs) produced by CHO cells have played a major role in both the diagnostic and therapeutic markets for decades.

  6. Keys To Successful Technology Transfers

    The choice of potential technology transfer partners can be bewildering. This article shares some of the factors that should be taken into account when making this decision.

  7. Selecting The Optimal Resins For IgG Process Purification

    Immunoglobulins (Ig), or antibodies (Ab), are the heavy globular plasma proteins produced in response to foreign bodies or antigens. They exist in five isoforms: IgA, IgD, IgE, IgG, and IgM. IgG provides the majority of antibody-based immunity. By Payal Khandelwal, PhD

  8. Autologous Cell Therapies At Crossroads With FDA: What Can You Do To Help?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?

  9. 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.

  10. Tips On Selecting A Liquid Chromatography Resin

    There is a wide array of chromatography resins available to address the evolving needs of researchers purifying a diverse set of target molecules.