Bioprocessing White Papers

1. Drug Repurposing Trends And Strategic Approaches For Shortening Timelines 4/15/2021

   As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

2. Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions 4/13/2021

   During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

3. The Science Of Cell Therapy Thawing 4/5/2021

   This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.

4. Downstream Manufacturing Of Gene Therapy Vectors 4/1/2021

   The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled. This paper identifies challenges and opportunities to improve current operations and maximize yield.

5. Alternative Buffer Management Strategies To Achieve Downstream Process Improvements 3/23/2021

   Understanding the alternative buffer management strategies available and the resources needed to execute them can help ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.

6. Achieving A F.A.I.R. Data Management Strategy 3/23/2021

   Recently many industry leaders have been highlighting the problems of not having F.A.I.R. data. For example, a recent report estimates that data that is not findable, understandable or has incomplete metadata introduces inefficiencies and negatively impact research quality, ultimately costing the European economy in excess of €26 billion per year. In this white paper, we explore what the F.A.I.R. principles mean in practical terms for your R&D data management strategy before describing how IDBS enables organizations to make their scientific data Findable, Accessible, Interoperable and Reusable and mitigate the costs of not being F.A.I.R.

7. Antibody Affinity Extraction™ (AAE™) Empowers HCP Identification By Mass Spectrometry 3/23/2021

   Host cell proteins (HCPs) co-purify with biological drug substances (DS) and pose potential risks for both patients and drug manufacturers. Identification and quantification of HCPs by mass spectrometry (MS) is a powerful complementary method to ELISA, however drug substances often mask HCPs. Here we demonstrate how AAE empowers MS identification of CHO HCPs in the presence of DS.

8. Antibody Affinity Extraction (AAE) - An Alternative To 2D Western Blot For Determination Of Polyclonal Anti-HCP Reactivity 3/23/2021

   Antibody Affinity Extraction is a novel method developed by Cygnus Technologies to test reactivity of polyclonal anti-HCP antibodies to individual HCPs that co-purify with biopharmaceutical products. In this paper has evaluated three methods to analyze the coverage of polyclonal antibodies to a population of host cell proteins using two-dimensional separation. Observe how with AAE we now have the ability to look at downstream HCPs to determine objectively if a process-specific assay is necessary and superior to a well-developed generic or platform method.

9. Bringing The Freezing Of Biopharmaceuticals In From The Cold 3/18/2021

   In this paper, we review end-to-end freezing solutions that integrate bulk filling, storage, shipping, thawing, and fill-finish operations to minimize risk and preserve product quality.

10. Producing Publication-Quality Data With Automated Western Blots 3/16/2021

    How Simple Western overcomes the challenges and pitfalls associated with traditional Western blots to produce publication-ready data that meets the highest standards of data integrity and rigor.