This week’s headlines include: A Look at Major Drug-Pricing Proposals, Kite gets FDA priority review for KTE-C19, putting it 2 months behind Novartis in race for CAR-T market, JSR Corp arm KBI Biopharma to invest $ 30 mn to expand two facilities in US, ImmunoGen Licenses Cancer Compounds to Sanofi, Philips in deals with U.S. hospitals on use of its gene data platform for cancer research, and Death rate from Alzheimer’s disease in the US has risen by 55%, says CDC,” CNN.com
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
For many years cylindrical stainless steel tanks have been used in biopharmaceutical production. The primary reason for the cylindrical shape was that it provided the mechanical stability required for high-pressure steam sterilization…
Biotherapeutic production is increasing and is worth over $100 billion in annual revenues. While the industry is growing, there are pressures to reduce the costs associated with production. One way to address production costs is by increasing the yield of the cell “factories” that make therapeutic proteins. Increasing titer sometimes comes at the cost of protein quality. However, efforts to increase cell productivity cannot occur at the expense of eventual therapeutic efficacy. Sometimes a tradeoff is made where lower yields are accepted in order to assure that critical quality attributes remain within specification…
Reproducibility is a pillar of research. Studies must be reproducible to have merit. This is for good reason, as research is foundational, one study builds upon another and so on with each group contributing their piece to the overall puzzle. At least this is the way it is supposed to work. However, when research is reported erroneously, it creates a tremendous waste of time and resources for the entire research community working on the same application. While concerns about reproducibility have been discussed for years, the problem more recently has escalated to what is frequently called a “reproducibility crisis”…
In this podcast, we interviewed Sarah Simons, Automation Field Project Manager, Beckman Coulter Life Science, about how to improve lab productivity and reproducibility by “spring cleaning” your methods and taking a fresh look at existing workflows and protocols…
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…
In the development of biopharmaceuticals there are times when an off the shelf affinity chromatography medium is unavailable or isn’t highly selective for the target molecule being purified. It is possible then to design a custom chromatography solution by coupling a specific ligand to a pre-activated resin…
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks. Making monoclonal antibody (mAb) drugs? Safety first. In releasing a biomedicine, the last thing a biopharma company wants is for people to be harmed. This makes the risk of bioburden, and how it can be prevented, a major issue for drug safety…
Presented by: Catherine Allioux & Caine Leong, Ph.D.
Date: Thursday, June 08, 2017 – 1:00 PM EDT
Duration: 1 hour
Downstream process developers are continually seeking contemporary ways to enhance the removal of HCPs and aggregates during mAbs production.
You are invited to register for a webinar on June 8th, to discover how you can eliminate these challenges with versatile solutions that deliver successful removal of HCPs and aggregates over a broad range of conductivity and pH to fit with any mAb, while using a platform process adaptable to both batch and continuous processing.
Attendees will gain firsthand methodology and insights on optimizing process development requirements with CMM HyperCel™ high capacity cation exchange mixed-mode sorbent from a team of Pall Life Sciences experts. The webinar will close with a Q&A session.
Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.
On June 14th at 1pm EDT, Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.; he will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.
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.
Cell Culture Events:
MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.
“Several bills that seek to tackle the high cost of prescription drugs are moving through Congress, and the Trump administration has also signaled that it may take action. Here’s a list of the major drug-pricing proposals under consideration…”
“Kite gets FDA priority review for KTE-C19, putting it 2 months behind Novartis in race for CAR-T market,” Fierce Biotech
“Kite Pharma has secured a priority review at the FDA for its CAR-T candidate. The shaving of four months off the review time tees Kite up to secure approval by the end of November, two months after Novartis is expected to get the all-clear to start selling its rival CAR-T therapy…”
“KBI Biopharma (KBI), a subsidiary of JSR Corporation (JSR), is expanding its biopharmaceutical manufacturing capacity and capabilities at both its Durham, North Carolina and Boulder, Colorado facilities. KBI will invest approximately $ 30 million in the two site expansion projects, which will greatly enhance the offerings at each site and are scheduled for completion later this year…”
“ImmunoGen said today it has granted exclusive licenses to four compounds using its technology that are being developed by Sanofi, under amendments to the companies’ 14-year-old collaboration. ImmunoGen, which focuses on antibody–drug conjugates (ADCs), agreed to amend a 2003 agreement between the companies by granting Sanofi a fully paid exclusive license to develop, manufacture, and commercialize four cancer candidates…”
“Philips in deals with U.S. hospitals on use of its gene data platform for cancer research,” Reuters
“Dutch healthcare technology company Philips said Thursday it had reached deals with New York’s Memorial Sloan Kettering Cancer Center (MSK) and Utah-based Intermountain Healthcare for them to use its genomics platform for cancer research and treatment…”
“The rate of people dying from Alzheimer’s disease in the United States rose by 55% over a 15-year period, new data from the Centers for Disease Control and Prevention shows…”