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.
In this webinar Lucia Marani, Analytical Development Scientist from Oxford BioMedica about applications of the OsmoTECH osmometer. Kendal Studd, Scientific Application Specialist for Advanced Instruments rounds off the session by presenting a summary of published research showing that in vector manufacturing, osmolality is a factor in control of stability and aggregation for lentivirus and other viral vector types.
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.
Natural killer (NK) cell therapy is a rapid emerging field with several advantages over chimeric antigen receptor (CAR) T-cells for cancer treatment. Like any biotherapeutic drug, cell-based therapeutics must also undergo tight scrutiny for their critical quality attributes (CQAs). There are different criteria evaluated for drug purity, with the presence of visible and sub-visible particulate matter being one of them. Particulate impurities can affect drug efficacy and stability but can cause undesirable immunogenicity and toxicity when injected. In this webinar, we will showcase Micro-Flow Imaging (MFI) as a sub-visible particle analysis solution to differentiate NK cells and its expansion components with either irradiated K-562 feeder cells or Cloudz™ microspheres.
Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.
In this tutorial, Bill Saccoccio, AI Service Technician, will cover the available options for archiving data from your osmometer and provide guidance on how to connect to a network, LIMS system, or ELN among, others.
If you’re using or planning to use your Advanced Instruments osmometer in a GMP environment then its level of compliance will be part of the discussion during an inspection by regulators such as MHRA, FDA or others. In this session, Ian Ramsay of Ramsay Pharma talks about the deficiencies typically encountered during inspection, in particular, relating to data integrity.
This webinar targets the full life cycle safety. From the process score application to disposal of a single use enclosure and eliminating cleaning with proven performance, this webinar walks through the entire process. It will show you a well designed single-use flexible enclosure system which delivers equivalent if not better containment performance as a hard-shell isolator at a fraction of the cost.
Developments in MAb and Cell and Gene therapies and the need for “warp speed” vaccine development all bring challenges to the formulation of drug products. This is especially the case in a more heavily regulated biopharmaceutical environment. This workshop will dive into how osmolality measurements aid formulation development strategies to ensure consistent and painless injection whether of rapidly developed vaccines, biologic drugs or cryo-preserved cell therapies.