This week’s headlines include: GSK and Gilead join global efforts to tackle novel coronavirus, WHO says Wuhan coronavirus outbreak is not yet a pandemic, Merck to slim down with asset spinoff, focus on Keytruda, vaccines, Trump calls for bipartisan bill to ‘dramatically’ lower drug prices, Another HIV Vaccine Clinical Trial Fails, and FDA Calls for Bacitracin Products to be Removed From the Market.
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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.
May 18-19, 2020 – Minneapolis, MN
The course is offered for both in class attendance and over the web for those who cannot attend in person.
The course is designed for a wide range of participants. The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example. Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees. The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.
- 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.
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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…
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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…
“As confirmed cases of the novel coronavirus continue to rise, GlaxoSmithKline and Gilead have joined the global efforts to tackle the infection. With global concern rocketing as cases rise, the pharmaceutical industry has amped up its efforts to help tackle the growing health issue, offering expertise as its rallies on a shared ambition – to rapidly develop therapeutics and vaccines which can be used against the coronavirus…”
“The Wuhan coronavirus outbreak is not a pandemic, World Health Organization officials said Tuesday, adding that they’re hopeful transmission of the virus can be contained. The agency acknowledges that it is challenging to contain the virus because of global mass movement…”
“Merck & Co Inc (MRK.N) said on Wednesday it will spin off its women’s health, biosimilar drugs and older products into a separate publicly traded company as it tightens its focus on growth drivers like cancer drug Keytruda and vaccines. The new company’s assets currently make up around 15% of Merck’s total sales and around half of its drugs that treat people…”
“President Trump on Tuesday called on Congress to pass bipartisan legislation to “dramatically” lower the cost of prescription drugs. “I am calling for bipartisan legislation that achieves the goal of dramatically lowering prescription drug prices,” Trump said in his State of the Union address. “Get a bill to my desk, and I will sign it into law without delay.”
“The National Institutes of Health has halted a major clinical trial for an HIV vaccine after an independent panel determined that the injections provided no protection against the virus, according to a statement released today (February 3)…”
“The US Food and Drug Administration (FDA) on Friday requested that all current manufacturers of bacitracin for injection voluntarily withdraw their products from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema, which is a collection of pus in the lungs, caused by staphylococci. Manufacturers with bacitracin injections on the market, according to the Orange Book, include Akorn, Fresenius Kabi, Pfizer and Mylan…