This week’s headlines include: F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment, Sanofi to Buy Insect Cell Vaccines Company Protein Sciences for Up to $750M, Measles ‘tragedy’ kills 35 across Europe, Computer-Simulated Tests Eyed at FDA to Cut Drug Approval Costs, FDA Approves First New Sickle Cell Drug in Almost 20 Years, and UK launch for Pfizer’s MenB jab Trumenba.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Smart in-line cell culture monitoring as an efficient way to measure viral load in real-time. This kind of real-time measurement is only possible with the iLine F. The iLineF is an innovative microscopy technology that instead of taking a 2D image of a microscopic object, takes a hologram of a microscopic volume. Then for each microscopic object within the culture volume, it can compute a holographic fingerprint. This fingerprint can then be used to analyze, identify, count and assess viability of cells in culture…
Characterization and analysis of subvisible particles of biological origin can be challenging or give insufficient information. In this study Adeno associated virus (AAV) particles contaminated by host cell proteasomes are analysed with direct versus indirect methods performed in a standard laboratory setting to reveal the difference in performance and quality of the information obtained. The focus is on the ability to detect the AAV particles of interest and distinguish them from the contaminating proteasomes…
Hematopoietic stem and progenitor cells (HSPCs) hold tremendous therapeutic potential for use in cell therapies to treat blood cancers and other blood diseases including sickle cell anemia and immune related disorders. HSPCs most frequently are sourced from donor blood or bone marrow. These cells are rare with only 1 in 100,000 found in peripheral blood cells and 1 in 10,000 found in bone marrow. In order to achieve the dosage required for most cell therapies (100’s of millions), cells must be successfully expanded to high numbers in culture. However during expansion, cells must also maintain the progenitor cell properties including the potential to differentiate and mature into the various hematopoietic lineage cells required for therapeutics…
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…
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 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…
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…
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.
The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
Presented by Robert Dream, PE, CPIP of HDR COMPANY LLC
“A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease…”
“Sanofi to Buy Insect Cell Vaccines Company Protein Sciences for Up to $750M,” Genetic Engineering News
“Sanofi is looking to bolster its recombinant-based influenza vaccine portfolio through the acquisition of Protein Sciences for $650 million upfront and potentially up to another $100 million in milestones. The transaction, which has been approved by the Protein Sciences board and the majority of its shareholders, is expected to close during Q3 2017, subject to regulatory clearance…”
“Thirty-five people have died in the past year from measles outbreaks across Europe, the World Health Organization has warned. It described the deaths – which can be prevented with vaccination – as an “unacceptable tragedy”…”
“Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply. The U.S. Food and Drug Administration outlined a proposal Friday to help integrate computer modeling and virtual testing as part of the regulatory approval process for manufacturers — a step the agency said could save money while helping find cures for puzzling conditions such as Alzheimer’s disease…”
“The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years…”
“Pfizer’s new meningitis B vaccine Trumenba is now available in the UK for teens and young adults providing an additional option for vaccination against the disease…”