INSIGHTS ON DOWNSTREAM MANUFACTURING

• Natrix® Q Chromatography Membrane

  Strong anion exchange (AEX) chromatography has become an industry standard in polishing steps for monoclonal antibody (MAb) purification. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins (HCP) from process feed streams in flowthrough mode. This application note examines the performance of Natrix® Q chromatography membrane in comparison to currently available quaternary amine resins, membranes and salt-tolerant primary amine membranes.

• Improve Quality & Yield For Viral Vector Manufacturing Using Osmolality: Unveiling Exciting New Data From Cell Gene Therapy Catapult

  While cell and gene therapies can potentially revolutionize disease treatment, challenges remain in order to make these novel drugs accessible to larger patient populations. An important question for scientists in the area is, ”What tools and checks can be implemented to ensure consistent product and process control”? Osmolality, a measure of solute concentration, has long been considered a critical measurement in Biopharma describing how much of a solute is present in a given solution. More recently, it has been shown to be strongly implicated across the entire gene therapy process workflow.

• Enabling Broader Adoption Of Process Intensification In Biopharma

  PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.

• Shaping The Future Of Formulation Development With Melt-Based 3D Printing Technologies

  In this white paper, the use of 3D printing to overcome challenges during formulation development is explored, with a focus on enhancement of bioavailability of active pharmaceutical ingredients (APIs) in solid dispersions. It is estimated that 60–70% of drug substances currently in clinical pipelines are categorized as Class II in the Biopharmaceuticals Classification System (BCS) which indicates low solubility. For an oral formulation, the proper API solubility is critical for absorption in the gastrointestinal tract. If solubility issues cannot be overcome during formulation development, an otherwise promising therapeutic candidate may have to be abandoned.

• Affinity Capture Of Antibody Fragments

  7/9/2021

  Stepping away from the classical antibody constructs comes with challenges, as modifications are necessary to develop an effective and robust manufacturing process on an accelerated timeline. In this webinar we review how on our alkali stable Protein A resin Amsphere A3 has shown to be an effective platform capture step for a wide range of antibody fragment variants, which enables significantly more convenience in developing downstream processes for these types of biotherapeutics.

• Complex Pump-Driven Blending In A Bioprocess Application

  7/8/2021

  There are quite a few applications that require multiple streams to converge into a single process flow. Two such examples are buffer formulation and liquid chromatography gradient elution. Utilizing robust, flexible automation software capable of maximizing the utility of the equipment’s pumps, instrumentation, and overall design can achieve precise control over complex blends.

• Virus Filtration Assurance Through Automation

  7/8/2021

  Learn how to achieve virus filtration assurance with a purpose-built automation software that integrates our filtration expertise into your manufacturing suite at every step of the process.

• pDNA Manufacturing: An Optimized Platform Process

  6/28/2021

  Explore a platform purification process that addresses the main challenges in the large scale manufacturing of pDNA, such as scalability, quantity, and quality, as well as pDNA analytics.

• Overcoming Obstacles In AAV Viral Vector Manufacturing

  6/24/2021

  Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. The upstream and downstream processes of AAV manufacturing can be fairly straight-forward at small scales. However, obstacles often are encountered when a developer progresses toward larger volumes for clinical and commercial manufacturing. In this article we discuss overcoming obstacles that often come up during transfection, clarification, and the separation of empty and full capsids.