INSIGHTS ON DOWNSTREAM MANUFACTURING

• Meeting The Process Development Challenges Of A Diverse Biologic Pipeline

  The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  

• Downstream Process Intensification For Virus Purification Using Membrane Chromatography

  Viruses and their components, given their central role in a variety of therapeutic modalities, must be produced via a robust and cost‑efficient process. This white paper provides an overview of the challenges presented by current approaches to virus production and the opportunities to develop a platform approach that can work across different viral modalities and accelerate process development.

• Key Considerations When Outsourcing An Aseptic Fill/ Finish Project To A CMO Partner

  In this presentation, we discuss key elements to consider when choosing to outsource drug production. We will cover the importance of seeking the right partnerships to help overcome complex challenges and Samsung Biologics’ responsibility to leverage capabilities, optimize process efficiency, assure successful delivery, and provide the assurance of secure commercial product supply.

• Ensuring Everything is A-OK At AKBA

  With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical that the equipment and systems they develop for those applications meet the strict operational needs and characteristics of the manufacturing systems used by their clients. In both IBF and virus filtration processes pumps play a leading role in ensuring that the final product is manufactured properly. For AKBA one key to its success has been the incorporation of Quattroflow™ Quaternary (Four-Piston) Diaphragm Pumps into its critical Inline Buffer Formulation (IBF) and Virus Filtration systems.

• Protein A Resin For Antibody Fragment Purification

  The webinar recording reviews an application of alkali stable protein A for the purification of fragment antibody molecules. It will cover the binding mechanism between the engineered C domain of the Amsphere™ A3 protein A (PrA) ligand and a VHH single-domain antibody (sdAb), Protein A – Ab fragment complex structure via x-ray crystallography and CH1 binding capacity and purification case study results.

• Navigating The Road To Gene Therapy Commercialization

  With increases in development and investments in the gene therapy field, companies will increasingly be looking at manufacturing and commercialization of their therapies. Road to commercialization goes through a series of process validation phases. In this webinar, we take a closer look at the road to commercialization and focus on addressing primary questions.

• An Introduction to High Containment For Lyophilization Processes

  Almost every pharmaceutical and biopharma lab in the world are using lyophilization in their daily processes. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredients, protein, collagen, peptide, oligonucleotides, chemical API, enzymes, and mAbs. This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.

• Downstream Process Intensification For Virus Purification

  With the rise of gene therapy as a promising treatment modality, the industry is facing increasing pressure to decrease overall manufacturing costs, shorten product development timelines and increase production. This webinar focuses on intensified downstream process using high-productivity, single-use chromatography membrane adsorbers.

• Optimization, Validation And Implementation Of Retroviral Retentive Filters For Production of Adeno-Associated Virus (AAV)

  Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter.