This week’s headlines include: Tracking and Tracing Drugs and Vaccines: WHO Drafts New Policy, How will coronavirus hit U.S. drugmakers? Depends what kind of drugmaker you are: Moody’s, Bristol-Myers’ CAR-T gets priority review, mid-August PDUFA date, Sanofi teams up with U.S. agency against coronavirus, and Buffett’s a believer: Berkshire bets $192M on Biogen ahead of key Alzheimer’s filing.
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:
Last chance to save 10% off BPI West Exhibit Hall Passes and Main Conference Passes with this link. Expires 2/21. See you there!
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.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Don’t miss our top articles of 2019! I have compiled a list of our most popular 25 articles for 2019 in alphabetical order…
Rapid Spent Media Analysis of Metabolites During Cell Line Development for Better Product Quality Outcomes
Spent 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 Substance
In 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…
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Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…
Don’t miss our top articles on downstream processing for 2019! I have compiled a list of our most popular articles from 2019 in alphabetical order…
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…
“The World Health Organization (WHO) is seeking comments on a draft policy to help guide national regulators seeking to use international harmonized standards for creating systems to track and trace pharmaceuticals and vaccines through their supply chains…”
“How will coronavirus hit U.S. drugmakers? Depends what kind of drugmaker you are: Moody’s,” FiercePharma
“There’s no doubt the ongoing novel coronavirus outbreak poses a major threat to people’s health. But for U.S. biopharma companies, the impact on their businesses may be mixed, Moody’s said. If the virus persists long enough, branded drugmakers may see decreased demand for their innovative drugs in China, the credit rating service said in a report on Wednesday. But on the other hand, the global spread of the virus could lead to government stockpiling of certain drugs such as antivirals…”
“The FDA has accepted Bristol-Myers Squibb’s lisocabtagene maraleucel for priority review, setting the stage for a mid-August decision on whether to approve the CAR-T therapy. Bristol-Myers arrives at the FDA with data to suggest the cell therapy can hold its own against Gilead’s Yescarta and Novartis’ Kymriah…”
“French drugmaker Sanofi is working with a U.S. government agency to develop a vaccine against the new coronavirus from China, saying it could have a candidate ready for clinical trials within a year. At least a dozen other drugmakers are currently working on vaccines or antivirals and other treatments to help those infected with the fast-spreading deadly virus, with some antivirals already being used in clinical trials…”
“Buffett’s a believer: Berkshire bets $192M on Biogen ahead of key Alzheimer’s filing,” FiercePharma
“Warren Buffett often talks about how a successful investment is built around the target company’s competitive edge or so-called “moat.” Now, the American tycoon thinks he has spotted a technology fortress in Biogen. Buffet’s Berkshire Hathaway bought 648,447 shares of the Big Biotech at a combined worth of $192.4 million near the end of 2019, the investment shop disclosed in a recent securities filing…”