This week’s headlines include: Sanofi to invest further in biologics, Priority Generic Drug Reviews: New FDA Draft Guidance, Clovis’s ovarian cancer drug set for label expansion, shares soar, Cell Medica Acquires Catapult Therapy for Lead WT1-TCR T-Cell Therapy, Danger map reveals health threat zone, and FDA Approves Quicker-To-Administer Drug for Blood Cancers.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
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…
One of the most popular traditional cloning techniques is limiting dilution. The technique is cost-effective and has received regulatory acceptance for several years. In limiting dilution cloning, a mixed population of cells is diluted in liquid media and is dispersed into 96-well plates or other culture vessels. The goal of this method is to isolate individual cells into single wells or vessels. In order to accomplish this, the wells are seeded at an average density of less than one cell per well. While low seeding density increases the chance of isolating single cells into single wells, it also means that there will be more empty wells. Empty wells represent a waste of personnel time, consumables and lab space. Nonetheless, no matter how low the seeding density, some wells will still contain multiple cells or doublets. While the limited dilution method is still very popular, it is time consuming and labor intensive. With advancements in cell line development and successful alternatives available, many groups are looking to replace limiting dilution with more advanced and robust technologies…
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…
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…
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.
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.
“Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential…”
“Clovis Oncology Inc said on Monday late-stage data on its already-approved ovarian cancer drug showed that the treatment could benefit four times as many patients, sending shares of the U.S. biotech soaring 50 percent…”
“Cell Medica is buying Catapult Therapy TCR and the firm’s gene-modified WT1-TCR (Wilms’ tumor 1 protein–T-cell receptor) T-Cell Therapy candidate. The treatment is currently in Phase I/II development for the potential treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)…”
“The EcoHealth Alliance in New York looked at mammals, the viruses they harbour and how they come into contact with people. It revealed bats carry more potential threats than other mammals. The researchers hope the knowledge could be used to prevent the next HIV, Ebola or flu…”
“U.S. regulators have approved a more convenient version of a blockbuster drug for treating three common blood cancers. The Roche Group’s Rituxan, on the market for 20 years, is administered in a hospital or clinic through an intravenous drip that can take several hours. On Thursday, the Food and Drug Administration approved the Swiss drugmaker’s new version, Rituxan Hycela (RIH’-tux-en HEYE’-cell-uh). It’s injected in about six minutes, shortening clinic visits…”