Podcasts:Check out our podcast channel. We have over 40 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:
- The challenges of sterilizing liposome-based drugs prior to filling.
- A scalable method for producing liposomes with cGMP capability.
- Critical process parameters for sterilizing filtration of complex liposomal fluids.
- How to optimize sterile filtration of complex fluids and increase filter throughput using an example. Thursday, March 19 8:00 PST; 11:00 EST; 15:00 GMT; 16:00 CET Tuesday, March 24 8:00 GMT; 9:00 CET; 13:30 IST; 17:00 JST
- Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
- Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
- Equipment, reagents and supplies used in preservation,
- The challenges in implementing preservation in a clinical/GMP environment,
- Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
- Design and operation of a storage facility for cryopreserved cells,
- Regulatory issues associated with preservation of a therapeutic product,
- Emerging technology and approaches for the preservation of cells.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Cool Tool – Real-Time Protein Titer Measurement Provides Fast, Simple Solution for Process Development and ProductionProtein titer data is a critical during process development and manufacturing of protein-based biopharmaceuticals. Speed and accuracy of this data is key in instituting a process analytical technology (PAT) approach, as this allows for monitoring critical process parameters (CPP) and informs real-time decision making. In addition, this type of data when collected during process development enables optimization of cell culture conditions, protein yield, bioreactor run length and harvest time. Collecting this data during a bioreactor run is ideal, but can be time consuming and resource intensive with traditional tools…
Rapid Spent Media Analysis of Metabolites During Cell Line Development for Better Product Quality OutcomesSpent media analysis is an important tool used to provide crucial information about the amino acids and nutrients that cells use during growth phase. Spent media analysis also provides details about the metabolites that are produced as a result of cell growth. This is useful to cell line and process development teams in that it provides data on media composition performance, optimal harvest time and product quality changes that can occur during culture…
CryoVault™ Freeze and Thaw Platform Provides a Scalable, Robust and Single-Use End-to-End Solution for Bulk Drug SubstanceIn this podcast, I talked with Max Blomberg, Executive Director of Operations and Andrew Govea, Senior Product Engineer, at Meissner about the challenges of handling bulk drug substance, specifically freeze and thaw and how the need for scalability, flexibility and a robust approach led to the development of CryoVault™. CryoVault™ offers a unique and intelligently designed end-to-end freeze and thaw process solution…
Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test ApproachViral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…
Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ LEver since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies1. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy2…
“The outbreak of the novel coronavirus has revealed the vulnerability of the supply chain of drugs that originate in China, which is the main supply source of raw ingredients for penicillin, ibuprofen, and aspirin. However, drugs are frequently announced to be in short supply. In fact, the FDA has a running list of drug shortages due to anything from increasing demand to regulatory factors as well as supply disruptions…”