This week’s headlines include: Suspected Cases of Ebola Rise to 29 in Democratic Republic of Congo, Cromwell’s Biological Industries inks stem-cell training pact with Calif. Institute, AstraZeneca shares surge after key drug shows promise in lung cancer trial, Johnson & Johnson sets sights on introducing 11 blockbusters by 2021, Immunomic Licenses CMV-Targeting Tech from Annias for LAMP-Vax Cancer Vaccines, and Scientists to Test Whether Zika Can Kill Brain Cancer Cells.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
We recently finished our Ask the Expert discussion, “GMP Proteins for Cell Therapy Manufacturing”. During this Ask the Expert session, we discussed differences between research use only and GMP proteins. Specific topics included quality testing, FDA support, supplier responsibility, and transitioning from research use only to GMP proteins…
There are an increasing number of T cell-based therapeutics moving through clinical trials. These immunotherapies hold tremendous promise and much of the clinical trial data has been impressive. As these therapies have progressed toward larger trials and commercialization, focus is shifting from proof of concept to consistent and sustainable manufacturing…
It’s not surprising that many scientists are creatures of habit. After all, the “re” in “research” often feels like it stands for “repeatedly”. This attitude means that more often than not, scientists will develop a preferred “go-to” protocol. These are the ones that have been run countless times over the years, and become the protocol to learn for anyone new to the group…
GMP (Good Manufacturing Practice) growth factors and cytokines designed for therapeutic manufacturing are a critical component in defined medias. To date, the Cell Therapy industry has accepted the term GMP for this reagent class despite the fact that there is no direct oversight by regulatory authorities. These proteins are intended to be used during further manufacturing and do not come in direct contact with the patient. In fact, Cell Therapy manufacturers need to take steps to ensure that reagents used for further manufacturing are removed before the cells can be used in the clinic. In addition, FDA-regulated, clinical grade proteins that can be directly used as therapeutics may also be described as GMP, leading to confusion of the term “GMP” within different contexts…
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…
Since the 1980’s monoclonal antibodies have revolutionized medicine and become a vital tool in fighting many diseases. While there are many new monoclonal antibodies in the clinical trial pipeline, there are also some innovative drugs made from just an antibody fragment. Due to the multi-domain structure of antibodies, it is possible to create smaller antibody fragments that still include the antigen-binding domain. Antibody fragments have some advantages over full-length antibodies and several antibody fragment-based biotherapeutics are in clinical research. Several antibody fragments have been approved and are commercially available, including: ReoPro®, Lucentis®, and Cimzia®.
Single-pass tangential flow filtration (SPTFF) technology from Pall Life Science is a versatile concentration approach for biotech, vaccine and plasma industry applications. Patented Cadence™ SPTFF technology offers a total solution for inline volume reduction and/or concentration, in-process dilution/de-salting, high concentration formulations, and processing of fragile molecules, crucially enabling integrated, streamlined and continuous bioprocessing initiatives.
Join our webinar on May 23rd at 1pm EDT, when moderator Kevin Marino and presenter Jon Petrone provide an overview of SPTFF technology, including case studies where this novel technology was applied to enhance processes and reduce bottlenecks in production.
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.
Expansion of MSCs for Translational Medicine using NutriStem® MSC Basal Medium and PLTMax® Human Platelet Lysate
Thursday, May 25, 2017, 11:00 AM ET
Speakers: Lia Thornberry Kent, Biological Industries USA
Vanesa Alonso-Camino, PhD, Mill Creek Life Sciences
One of the biggest challenges in Cell Therapy-based regenerative medicine is the difficulty of expanding mesenchymal stem cells (MSCs) in vitro. Traditionally, fetal bovine serum (FBS) has been used as the main supplement for the in vitro culture of MSCs. However, the use of xenogeneic elements, particularly bovine-sourced materials, to culture human cells intended for clinical applications involves a series of potentially fatal risk factors, ranging from immunogenic responses against exogenous antigens to the transmission of diseases.
Human platelet lysate (hPL) derived from normal human donor platelets provides a xeno-free alternative to FBS as a supplement for vitro expansion of human cells for both research and clinical applications. In this webinar, we present a new clinically-relevant MSC culture medium comprised of NutriStem® Basic Medium supplemented with PLTMax® to culture MSCs. MSC NutriStem® Basal Medium supplemented with PLTMax® demonstrates faster growth kinetics than media supplemented with other commonly used reagents, such as human AB serum or FBS.
Attendees will learn the basics of growing human MSCs in MSC NutriStem® Basal Medium supplemented with PLTMax®, as well as the capabilities of this medium to promote high cell viability, chromosomic stability, and expansion.
Cell Culture Events:
Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA
The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.
Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.
Download Brochure: https://goo.gl/t5ZRvx
Register now: https://goo.gl/KTOdxq
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.
“The number of suspected cases of Ebola has risen to 29 from nine in less than a week in an isolated part of Democratic Republic of Congo, where three people have died from the disease since April 22, the World Health Organization said on Thursday…”
“Cromwell’s Biological Industries inks stem-cell training pact with Calif. Institute,” Hartford Business Journal
“Cromwell-based Biological Industries USA is partnering with a Monrovia, Calif.-based nonprofit stem cell institute to provide training for aspiring young scientists. Biological Industries’ partner, the Pathways to Stem Cell Science institute, will host early career scientists ranging from high school to college-level students and beyond and provide hands-on experience in culturing human pluripotent stem cells. Biological Industries will provide stem cell product and technology support through program scholarships for the Pathways to Stem Cell Science training programs…”
“A trial of AstraZeneca’s key immunotherapy drug durvalumab showed it reduced disease progression in lung cancer patients, sending the company’s shares higher and giving it a lead over rivals as it seeks to transform its oncology business…”
“Johnson & Johnson has listed the pipeline prospects it expects to drive the growth in its biopharma business for years to come. The company is hoping to get 11 potential blockhttps://downstreamcolumn.com/cool-tools/optimize-changeover-workflows-akta-readyflux-automated-single-use-crossflow-filtration-system/busters ready for market by 2021, starting with regulatory green lights for psoriasis candidate guselkumab and rheumatoid arthritis prospect sirukumab…”
“Immunomic Licenses CMV-Targeting Tech from Annias for LAMP-Vax Cancer Vaccines,” Genetic Engineering News
“Immunomic Therapeutics negotiated an exclusive license to Annias Immunotherapeutics’ platform covering technology for targeting cytomegalovirus (CMV) antigens in cancer. The CMV immunotherapy platform was developed by John H. Sampson, M.D., Ph.D., and Duane A. Mitchell, M.D., Ph.D., at Duke University and licensed to Annias. Immunomic will combine the CMV platform with its own nucleic acid-based immunotherapy LAMP-Vax™ technology as a potential treatment for cancers that express CMV, including glioblastoma multiforme (GBM). Financial details of the licensing agreement were not disclosed…”
“Scientists in Britain plan to harness the Zika virus to try to kill brain tumor cells in experiments that they say could lead to new ways to fight an aggressive type of cancer. The research will focus on glioblastoma, the most common form of brain cancer, which has a five-year survival rate of barely 5 percent…”