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.

DOWNSTREAM MANUFACTURING SOLUTIONS

  • Luina Bio carries out microbial aerobic and anaerobic fermentation, technical transfer, cell banking, process development and validation, analytical development, GMP production and stability studies.

  • Virosart® HF combines highest virus safety with excellent capacities. This high-speed virus filter is especially designed for easy implementation into single-use processes. The smart capsule design with low footprint and minimal flushing volumes can be easily implemented into pre-sterilized, ready-to-use assemblies.

  • Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance. This filter combines size exclusion mechanism with efficient adsorptive capacities to increase the robustness of the following virus filter. As a result, Virosart® Max ensures the highest protection of your final virus retentive membrane, significantly increasing its robustness and capacity.

  • Virosart® CPV is a well established virus retentive filter within the monoclonal antibody market. The unique asymmetric PES membrane structure provides highest virus retention under all circumstances independent from operation pressure or pressure pauses. Flexibility is given by using either cartridges in existing stainless steel housings or disposable capsules.

  • Virosart® Media is especially designed for virus filtration of chemically defined cell culture media. This high speed virus filter provides you with an economical solution suitable for upstream media virus filtration. Highest safety for your process is guaranteed by logarithmic reduction values of ≥ 4 log10 for small non-enveloped viruses. Easy implementation into single-use processes is given by gamma irradiatable capsule designs.