This week’s headlines include: Johnson & Johnson working on vaccine for deadly coronavirus, FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft, China Names HIV Drugs in Treatment Plan for New Virus, New Partnership Could Eventually Lead To ‘One-Size-Fits-All’ Cancer Vaccines, and White House announces task force to monitor coronavirus,
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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:
Applications Of Next-Generation Single-Use Bioreactor
Single-use bioreactors (SUBs) have transformed the biopharmaceutical industry in the past decade and are now well-established systems for producing recombinant proteins derived from mammalian cell culture. SUBs can offer certain advantages over stainless steel bioreactors including reduced capital cost, facility start-up time, equipment footprint, energy/utility requirements, and risk of product cross-contamination. Despite these advantages, SUBs have historically been limited by lower power per volume and oxygen mass transfer rates compared to stainless steel bioreactors. We have evaluated a new single-use bioreactor design (50L) that offers improved power per volume and mass transfer when compared to other commercially available SUBs. These improvements are the result of the unique drivetrain and vessel geometry. Additionally, the new SUB design includes a high turndown ratio, enabling multiple seed train stages to take place in a single vessel, which ultimately increases operational efficiency and reduces facility footprint. Furthermore, this SUB design has proven to be scalable across multiple vessel sizes. With these design improvements, the next generation SUB will be able to sustain higher cell densities that have been difficult to achieve with previous generation SUBs. Potential applications include process intensification and continuous processing.
Intensified mAb Processes & Insights Into Gene Therapies
April 7 and 8, 2020 | St. Louis, MO, USA
The Innovations in Upstream Development Technical Symposium for mAb and Gene Therapy will cover the latest trends, developments and technologies to get upstream development right the first time.
During this two-day seminar participants will:
- Network with peers and learn industry trends
- Gain insights on solutions for upstream through
- *Panel discussions with industry experts
- *A poster session highlighting innovations in upstream development
- Tour the Center of Excellence for media development
Attendance is complimentary, but advanced registration is required.
Virus Filtration: Get the Job Done!
Interactive Workshop 2020
Thursday, 12th March 2020 | Biotech Training Facility in Leiden, Netherlands
8:30 a.m. to 3:00 p.m.
This seminar will address the principles of virus filtration, and Pall
recommendations for filterability and virus validation studies. Our goal
is to enable all attendees to conduct a virus filterability trial
including prefiltration and be prepared to have the appropriate
discussions with a validation lab.
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…
“Johnson & Johnson on Wednesday became the latest drugmaker to begin work on developing a vaccine for a new coronavirus that has already killed more than 100 people in China, as health authorities race to contain the outbreak. J&J said its vaccine program would utilize the same technologies used to make its experimental Ebola vaccine, which is currently being administered in the Democratic Republic of Congo and Rwanda…”
“The US Food and Drug Administration (FDA) on Tuesday finalized six guidance documents on gene therapy development and released a new draft guidance on interpreting the sameness of gene therapies under the orphan drug regulations…”
“China is using AbbVie Inc’s HIV drugs as an ad-hoc treatment for pneumonia caused by the novel coronavirus while the global search for a cure continues. The Beijing branch of China’s National Health Commission said that a combination of lopinavir and ritonavir, sold under the brand name Kaletra by AbbVie, is part of its latest treatment plan for patients infected by the virus, which has killed at least 56 people in China and sickened more than 2,000 worldwide…”
“British scientists who announced last week their discovery of a new type of cancer-killing T-cell have entered a partnership with a biotechnology company pioneering the use of Dark Antigens to develop T-cell receptor (TCR)-based immunotherapies and off-the-shelf cancer vaccines. The result—they hope—will be a “one-size-fits-all” cancer therapy…”
“The White House on Wednesday announced the formation of a task force to monitor the coronavirus as global health officials seek to combat the outbreak of the disease in China. Press secretary Stephanie Grisham said in a statement that the task force has met daily since Monday and will lead the government response to monitor and contain the disease. President Trump chaired a meeting on the matter at the White House earlier Wednesday…”