This week’s headlines include: Immune discovery ‘may treat all cancer’, Weak antibiotic pipeline’ poses threat to AMR fight, Researchers Alter Mosquitoes to Resist Dengue Infection, Eli Lilly and Company taps Durham for 450+ jobs, new facility, BeiGene lung cancer treatment meets main goal in late-stage study, and PTC submits MAA for new gene therapy.
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The full agenda is now available for the upcoming BioProcess International US West meeting, held March 9-12, 2020 at the Santa Clara Convention Center in California.
One interesting talk to attend:
Upstream Raw Material Variation Monitoring and Control Stratgies
This presentation will discuss critical attributes for raw materials used in cell culture, analytical methods for measuring those attributes and how the lessons learned from raw materials used in large scale biopharmacuetical manufacturing can be applied to other biological modalities like cell and gene therapies.
This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.
Location: Biofactory Competence Center in Fribourg, Switzerland
January 28-30, 2020
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Don’t miss our top Podcasts of 2019! I have compiled a list of our most popular 10 Podcasts for 2020 in alphabetical order…
Nucleic acid-based vaccination is a promising technology that is particularly attractive to prevent or treat infectious diseases and cancer. A nucleic acid vaccine consists of a genetic sequence that is administered in vivo to be taken up by cells that will express at their cell surface or secrete the encoded antigen for induction of an immune response. Main technical challenges associated with the use of nucleic acid vaccines are efficacy and safety. To address these challenges, it is important to take into account the following parameters during initial research development of a genetic vaccine: the type of nucleic acid used and the delivery method…
There have been many improvements in the area of cell counting and several instruments have been developed to move away from time-consuming manual cell counting. However, even with automated devices, the lack of throughput for cell concentration and viability measurements can create a process bottleneck, particularly at large-scale or industrial manufacturing. In addition, this lack of high-throughput can limit experimental design or create resource demand that isn’t feasible when large numbers of samples need to be analyzed…
Oligonucleotides (OGN) are a class of therapeutics comprised of short strings of synthetic nucleotides. OGNs have the ability to to alter, suppress or restore expression of target genes associated with disease or health. This makes them uniquely positioned to provide treatment for diseases with a known genetic component. There are currently more than 80 companies currently investigating OGNs to treat diseases and it is a therapeutic modality that is growing dramatically…
The number of gene and cell therapies in the clinic is increasing rapidly. With the increase in gene therapy manufacturing, comes the need for improved analytics during the production process. Analytics for Lentivirus production is particularly important as it is currently the second most common vector used in cell and gene therapy manufacturing…
Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers? One possible solution is automating buffer preparation and I am pleased to share the following guest blog that discusses the advantages and addresses concerns about moving from manual to automated buffer preparation. I was fortunate to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…
Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach
Viral 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™ L
Ever 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…
To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers evaluated with much scrutiny. Several instances of drug shortages as the result of either a raw material shortage or contamination reinforce the need for thorough evaluation. Ensuring a reliable supply and the quality of the materials selected is of paramount importance…
Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…
“A newly-discovered part of our immune system could be harnessed to treat all cancers, say scientists. The Cardiff University team discovered a method of killing prostate, breast, lung and other cancers in lab tests. The findings, published in Nature Immunology, have not been tested in patients, but the researchers say they have “enormous potential”. Experts said that although the work was still at an early stage, it was very exciting…”
“The World Health Organisation (WHO) has revealed that declining private investment and lack of innovation in the development of new antibiotics are undermining efforts to combat drug-resistant infections…”
“Mosquitoes that can’t be infected by or spread dengue virus have been created by scientists. The researchers genetically engineered the mosquitoes to be resistant to all four types of dengue, a mosquito-borne virus that’s a significant global health threat. This is the first time that mosquitoes have been genetically engineered to be resistant to all types of dengue, which could significantly improve control of the disease, the scientists added…”
“Eli Lilly and Company plans to bring more than 462 jobs to a new Durham County facility. The drug giant picked Durham County for a $474 million investment over competing sites in both Indiana and Pennsylvania. The announcement was made Tuesday. Eli Lilly (NYSE: LLY) is planning what’s being described as an integrated life science manufacturing facility, one that will provide both drug formulation and filling as well as final packaging of both marketed and late-stage pipeline candidates…”
“BeiGene Ltd said on Tuesday its cancer therapy combination for treating lung cancer in previously untreated patients met the main goal in a late-stage study. The therapy, tislelizumab, when administered in combination with chemotherapy helped reduce the risk of cancer progression in patients with squamous non-small cell lung cancer…”
“PTC Therapeutics has filed a Marketing Authorisation Application (MAA) for the potential approval of a gene therapy treatment, PTC-AADC, the company has announced. Last year the drug garnered positive results in treating aromatic l-amino acid decarboxylase (AADC) deficiency, with data from a trial demonstrating clinically meaningful and sustained improvements in motor, cognitive and language milestones…”