The Dish’s Weekly Biotechnology News Wrap Up – June 30, 2017
This week’s headlines include: Repligen Merging with Spectrum Labs in $359M Deal, Needle-Free Flu Vaccine Patch Works as Well as a Shot, FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests, NYU scientists zero in on mechanism for removing plaque from arteries, BE Licenses Takeda’s Measles and Pertussis Vaccines for India and China, and Roche says new haemophilia drug cuts bleed rate by 87 pct.
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…
Cool Tool – Optimizing Vero Cell Culture Media with animal component-free, recombinant human serum albumin
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
Optimize Changeover Workflows with ÄKTA readyflux – An Automated, Single-use Crossflow Filtration System
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…
Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
Presented by: James Hathcock, Ph.D. & Hélène Pora, Ph.D.
Date: Thursday, June 29, 2017
Time: 11:00 AM PDT / 1:00 PM CDT / 2:00 PM EDT
Date: Tuesday, July 04, 2017
Time: 9:00 AM BST / 10:00 AM CEST / 1:30 PM IST / 4:00 PM SGT / 5:00 PM JST
Duration: 1 hour
A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.
Reviewing Continuous Chromatography Solutions, and the Effect the Number of Process Columns has on Specific Productivity and Binding Capacity
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.
“Repligen Merging with Spectrum Labs in $359M Deal,” Genetic Engineering News
“Repligen said today it plans to merge with privately-held Spectrum Laboratories, in an approximately $359 million deal that Repligen said will accelerate the growth of its filtration business and enhance its position as a leading developer of single-use and continuous-manufacturing technologies for bioprocessing…”
“Needle-Free Flu Vaccine Patch Works as Well as a Shot,” NBC News
“A press-on patch that delivers flu vaccine painlessly worked as well as an old-fashioned flu shot with no serious side effects, researchers reported Tuesday…”
“FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests,” Regulatory Focus
“NYU scientists zero in on mechanism for removing plaque from arteries,” Fierce Biotech
“Low-density lipoprotein (LDL) is commonly called “bad cholesterol” because it builds up along the walls of the arteries, forming plaques that can cause deadly blockages. But what if a key player in that inflammatory, plaque-building process also had the ability to switch roles, opening up and healing the arteries instead of blocking them?”
“BE Licenses Takeda’s Measles and Pertussis Vaccines for India and China,” Genetic Engineering News
“Biological E. (BE) negotiated two licensing agreements with Takeda for the latter’s measles and pertussis vaccines, which will allow BE to develop and commercialize affordable combination vaccines in India, China, and low- and middle-income countries. Takeda has sold both the vaccines in Japan for more than 20 years…”
“Roche says new haemophilia drug cuts bleed rate by 87 pct,” Reuters
“Roche’s investigational haemophilia drug emicizumab cut the bleed rate by 87 percent in patients who had developed resistance to standard treatment, compared with those who instead got bypassing agents, the Swiss company said on Monday…”