The Dish’s Weekly Biotechnology News Wrap Up – July 7, 2017
This week’s headlines include: FDA outlines plan to speed rare disease drug designation, Glimmers of hope for cancer vaccines as two neoantigen shots hit the mark, Big pharma turns to AI to speed drug discovery, GSK signs deal, A huge win for biology’: Trial shows anti-inflammatory drugs may reduce heart disease, and Scientists are dusting off a long-forgotten weapon to cope with modern bacteria.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Bioengineered organ implants poised to change treatment paradigms in esophageal cancer
In this podcast, we interviewed Jim McGorry, CEO and Saverio LaFrancesca, President and Chief Medical Officer about how Biostage is using Cell Therapy to improve the standard of care in adult and pediatric esophageal disease…
Vero cells are a monkey kidney cell line that has been a relative constant in the vaccine industry for over 3 decades. These cells have a long and successful history of safe vaccine production for many human and animal vaccines including polio, rotavirus, and smallpox. Vero cells are also a favored cell factory for the production of herpes, measles, and vaccinia-based viral vectors…
Automated Adenovirus Purity Analysis Speeds Viral-based Gene Therapy Process Development
Adenovirus-based vectors are commonly-used gene delivery vehicles, especially in Gene Therapy applications where their efficient nuclear entry mechanism and low pathogenicity for humans are much-valued attributes. In addition, Adenovirus vectors can be produced in high titers and the particles are stable yet easy to modify…
QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed that links material attributes and process parameters to CQAs. By understanding the impact of process parameters on CQAs a design space can be developed in which CQAs will be met. Bioprocess engineers must then implement a suitable control strategy that ensure the process operates with the design space. Continuous improvement activities can be performed throughout the product lifecycle and enhance product quality still further…
Fine Tuning Viral Clearance Approaches with a Total Viral Challenge Strategy
In this mini-webinar, Michael Burnham, M.S., Senior Principal Scientist, Process Development and Commercialization, WuXi AppTec, presents a viral clearance strategy that focuses on spiking load or starting material based on total viral load instead of percent spike model…
Continuous bioprocessing – moving from theory to reality
Continuous manufacturing has been established in several processing industries for many years, providing many benefits over batch manufacturing. The feasibility of continuous processing has now been shown for monoclonal antibodies (mAb) at both the process development (PD) and the production scales by early adopters…
Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark
Significant advances in analytical technology over the past few years have improved the quantification and characterization capabilities for subvisible ( 1 – 100 µm) and submicron particles (≤1 µm). As the technology continues to improve so do the expectations of regulatory agencies for sponsors to characterize particles in these size ranges. However, multiple orthogonal methods are required to span the entire range and accurately characterize the particle profile. Each instrument has its own limitations based on detection method and properties of therapeutic protein products that must be well understood to generate high quality data. KBI Biopharma has extensive experience with particle detection methods, as well as, in-depth particle data analysis. KBI’s Particle Characterization Core team can help choose appropriate orthogonal particle to combine in order to accurately quantify, characterize and identify particles in specific therapeutic protein products for all size ranges based on clients’ needs
Multiple buffers in a wide range of formulations are required to produce a single biopharmaceutical. Because of the large volumes required, buffer preparation can easily become a bottleneck in production. Traditionally, buffers are prepared manually in the volume needed according to specific recipes. Due to the large quantities used, buffer management requires careful planning and considerable floor space is required for the preparation and storage of such large buffer quantities. In addition to high labor and facility space cost, there is a risk of human error and variability associated with such a time-intensive manual activity. Buffer variability can affect both quantity and quality of the final product…
Webinars:
Reviewing Continuous Chromatography Solutions, and the Effect the Number of Process Columns has on Specific Productivity and Binding Capacity
SUMMARY
Continuous multi-column chromatography (MCC) has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.
Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.
Headlines:
“FDA outlines plan to speed rare disease drug designation,” Reuters
“The U.S. Food and Drug Administration plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of requests for rare disease drug designation, it said on Thursday. The agency plans to deploy a team of senior reviewers with expertise in drugs to treat diseases with 200,000 patients or fewer, known as orphan drugs…”
“Glimmers of hope for cancer vaccines as two neoantigen shots hit the mark,” Fierce Biotech
“Efforts to develop effective, personalized cancer vaccines have been largely unsuccessful to date, but two phase 1 studies suggest the tide could be turning. The results in the journal Nature add to the hope that the vaccines—which are directed at patients’ specific cancer mutations—could be combined with immuno-oncology drugs such as checkpoint inhibitors and deliver a double whammy to tumors, removing a brake on the immune response while also directing it toward the cancer cells…”
“Big pharma turns to AI to speed drug discovery, GSK signs deal,” Reuters
“The world’s leading drug companies are turning to artificial intelligence to improve the hit-and-miss business of finding new medicines, with GlaxoSmithKline unveiling a new $43 million deal in the field on Sunday…”
“‘A huge win for biology’: Trial shows anti-inflammatory drugs may reduce heart disease,” The Boston Globe
“Could we see an explosion of new anti-inflammatory therapies for heart disease? Perhaps. That’s because Novartis may have just helped validate a long-standing theory: That targeting inflammation could play critical role in reducing the incidence of heart disease…”
“Scientists are dusting off a long-forgotten weapon to cope with modern bacteria,” The Washington Post
“In 1915, British scientist Frederick Twort saw something weird happening to the bacteria that had invaded his viral cultures: They were disappearing, a sign they had been destroyed. Two years later, French-Canadian microbiologist Félix d’ Hérelle observed the same phenomenon in his own lab…”