The Top 20 Cell Culture Dish Blogs in 2014
I have compiled a list of our most popular 20 Blogs for 2014. Here are the top blogs in alphabetical order.
2013 FDA New Drug Approvals
The FDA recently released its report titled “Novel New Drugs 2013 Summary,” in which they discuss approvals that occurred in calendar year 2013. In 2013, the FDA approved 27 novel new medicines, called new molecular entities or NMEs. The number of approvals in 2013 was down from 2012 with 39 approvals and down from 2011 with 31 approvals. However when looking at the number of approvals over time, 2013 was consistent with the average over time. For instance, between the years 2004-2012 the average number of NME approvals was 26 per year……
The Benefits of Implementing Bioprocess Monitoring and Quality by Design in Process Development
Biomanufactuing processes are becoming increasingly complex, due in part to the increasing demands placed on biomanufacturing. There is a push to lower development and manufacturing costs while also increasing the number of products manufactured in a facility and to increase the speed at which this happens. To keep up with these needs there must also be regular improvements in manufacturing efficiency. This has driven innovation in these areas and has also expanded what is possible in terms of bioprocess monitoring and a gaining a better understanding of the biomanufacturing process……
Choosing a Cell Culture Media Development Strategy for Biopharmaceutical Production
In 2012, the three best selling drugs were biologics. While biologics continue to move into the top spots in drug sales, they are also more complex to manufacture than their small molecule counterparts. The manufacturing of biologics is an intricate process and a large part of that process is focused on product yield. Product yield drives manufacturing capacity, drug availability and drug cost. As a result biopharmaceutical companies are regularly searching for ways to improve yield. Factors that drive yield include, among others, unique characteristics of the cell line or product itself, cell culture media, product quality requirements, manufacturing equipment and downstream purification techniques.
This blog focuses on cell culture media and considerations for choosing a media development strategy for biopharmaceutical production. The primary focus is on CHO cell lines, since they are the predominant cell line used for manufacturing biologics. However, most of these options would also apply to other cell lines used in manufacturing, including stem cell lines…..
Flexible Facilities for Biopharmaceutical Manufacturing
The development and subsequent improvements to single-use systems have offered a more flexible approach to manufacturing and have enabled the development of flexible facilities that employ the use of single-use systems over fixed in place equipment. Single-use systems offer reduced installation time, lower water for injection use, quick turnaround time, easy validation, lower start up costs, reduced cleaning and sterilization requirements, and ready out of the box options. Key benefits of flexible facilities include: easy product changeover for multiple product lines, capital investment savings, shortened time to commercial manufacturing and capacity optimization……
A High Throughput, Scalable Solution to Upstream Process Development
There are numerous challenges to be overcome when developing upstream manufacturing processes for the production of biotherapeutic drug products. High levels of process understanding and robustness are required for cGMP manufacture; however, the time taken to obtain these must be kept to a minimum in order to reduce costs and meet constraints such as asset slots and clinical requirements. New high-throughput upstream development approaches, therefore, are particularly desirable. However, it is also desirable that these approaches are scalable and so applicable to the manufacturing equipment and facilities for which the processes are being developed. This provides confidence that the results obtained – and so the decisions made – are relevant, otherwise the potential implications could be costly in terms of money, time and resources….
Improving Clone Isolation and Screening In Hybridoma Cells – Moving away from Limiting Dilution
In successful hybridoma production, identifying hybridoma cell lines that have good manufacturing potential is key. To accomplish this, transfected or fused cell pools must be separated and cloned into monoclonal cultures. Thorough fusion screening and clone selection are crucial to an efficient and successful hybridoma program. The best clones, often called interesting clones, are stable and good producers that demonstrate specific attributes based on the product specifications.
The most prevalent traditional cloning technique, limiting dilution, has been used for many years, but it is both time- and labor-intensive. While this method has many drawbacks, it is still commonly used, particularly with hybridoma cells. Its widespread use is due primarily to the low cost of materials and low capital investment. However, the method is limited and with advancements in cell line development and successful alternatives available, many groups are replacing limiting dilution with more advanced technologies….
Interactive Scheduling is Key to Successful Biomanufacturing Operations
Biomanufacturing is a complex and hard to manage process that requires the ability to respond to multiple variables. Biomanufacturing planners and schedulers must consider various crucial factors including specialized labor needs, required manufacturing resources, juggling timelines, and unexpected delays when creating manufacturing schedules….
ISSCR Blog Series
Innovations Abound at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting
Stem Cell Culture Advances – The Final Blog in the ISSCR Series
In June I attended the International Society for Stem Cell Research (ISSCR) in Vancouver and began a series of blogs related to the information presented at the meeting. In today’s blog I will be covering novel technologies for reprogramming and characterization, new cell lines available and stem cell manufacturing. The daily Innovation Showcases were particularity interesting and focused on new, state of the art products or approaches that enable stem cell culture and research….
Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies – Part I and Part II
Researchers and product developers in the field of regenerative medicine face a complex set of challenges in translating stem-cell science from the laboratory through clinical trials and ultimately to patients. The California Institute for Regenerative Medicine (1) (CIRM), the Alliance for Regenerative Medicine (2) (ARM), and the Cell Therapy Catapult (3) (Catapult)convened a roundtable on June 25, 2013 to define technological challenges and identify potential solutions in three key areas: manufacturing clinical-grade cell products derived from stem cells, characterizing the cell product, and imaging cells after transplantation. This White Paper summarizes the proceedings from the roundtable and highlights key recommendations….
Paper or Plastic: A Study on Single-use and Sustainability
What is sustainability?
For some, the special meaning of the word in this application is how biological systems remain diverse and productive over time. In this way, sustainability is not just about saving resources or avoiding pollution within a narrow context – it’s more of a long-term holistic approach to our ecological-relevant activities. For others however, the term is used to include all environmental concerns, including those of a more immediate or non-biological focus; examples here might be a town’s solid waste disposal or a nation’s mineral resource depletion….
PCR Release Testing for Mycoplasmas Gaining Ground versus Conventional Methods
Biomanufacturing contamination is a very real concern for biopharmaceutical companies. Manufacturing shut downs due to contamination can result in regulatory fines, drug shortages, and medication rationing. In addition, lost revenue and lost market share can leave companies vulnerable and at risk of serious loss of stock value. While any contamination can be extremely challenging and costly, mycoplasma contamination is particularly difficult…..
Planting the seed: plant-based biologics for the expansion of therapeutic stem cells
The full realization of the therapeutic potential of stem cells has only recently come into the forefront of regenerative medicine. Promising in vivo results have fueled the enthusiasm among basic researchers and their clinical colleagues and thus have widened the scope of stem cell application in human disease but major scientific and regulatory challenges exist and must be addressed in order to both facilitate the “bench to bedside” process of this nascent technology as well as enhance safety of the final cell product. One potential key to advancing stem cell therapies is described in the recent benchmark publication entitled “Application of recombinant human leukemia inhibitor factor (LIF) produced in rice (Oryza sativa L.) for maintenance of mouse embryonic stem cells” by Youngblood et al. This paper describes how we expressed the human LIF protein (rhLIF) in rice grain using a plant-based expression platform (ExpressTec) and demonstrated a 97% purity of the protein. Subsequent biochemical analysis of the rhLIF showed similar biochemical characteristics as compared to rhLIF derived from E. coli….
Raw Material Sourcing for Cell Culture Media – Important Considerations
Biopharmaceutical companies have to manage complex supply chains to obtain the materials necessary to manufacture their products. One of the areas where supply chain management is critical is in the sourcing of raw materials for cell culture media. In many instances, companies will purchase a custom formulated dry powder media from a media supplier. In these cases, the biopharmaceutical company is relying on the media supplier to source the raw material components, however they will still need to audit the vendor and their supply chain management system. While the company may not be managing the raw material manufacturers directly, it is key that they understand their suppliers’ supply chain and have oversight…..
Reducing Footprints and Increasing Output in Adherent Cell Culture
The cells used to make many biologic products sometimes require a surface on which the cells adhere as they grow. Many vaccines, for example, are made in this way. Historically, the surface has been provided either by a two-dimensional (2D) system such as roller bottles, T-flasks, cell factories or cell stacks; or microcarrier beads within a traditional stirred tank bioreactor….
Release Your Cells – A Simple New Tool that Eliminates the Need for Manual Selection and Scraping in hPSC Passaging
One of the things I enjoy most at a conference is learning about new technologies, especially those that remove or reduce obstacles in scientists’ workflow. One of the areas researchers frequently find challenging when passaging human pluripotent stem cells (hPSCs), is the manual selection and scraping technique used to remove differentiated cells. Articles protocol for passaging these cells requires that areas with differentiation be manually identified and removed, usually through scraping. The remaining hPSCs are then detached from the surface of the plate (by adding a passaging reagent), broken into aggregates and re-plated for further expansion….
Reducing Footprints and Increasing Output in Adherent Cell Culture
The cells used to make many biologic products sometimes require a surface on which the cells adhere as they grow. Many vaccines, for example, are made in this way. Historically, the surface has been provided either by a two-dimensional (2D) system such as roller bottles, T-flasks, cell factories or cell stacks; or microcarrier beads within a traditional stirred tank bioreactor….
Single-use Perfusion Culture Enables Continuous Bioproduction
Many valuable features are provided by single-use (SU) technology, including lower initial investment, facility and operating costs. Biomanufacturers now employ significant SU technology in the majority of their cell culture applications. Most upstream operations are now supported by SU, including media and process liquid preparation and cell culture for seed generation and production. Single use bioreactors are now available up to a 2000L working volume….
Single-use Technology for Microbial Fermentation
Microbial fermentation processes are used for biomanufacturing of various drugs and vaccines, such as hormones, antibody fragments, and pneumococcal vaccine. Stirred-tank fermentors up to 100,000 L scale have traditionally been used in such microbial processes and their success has formed the general engineering foundation and principles of the design of bioreactors. The majority of today’s fermentation processes are performed in bioreactors constructed of traditional materials such as stainless steel. However, there is an increased interest in disposable technology to gain flexibility, save batch change-over time, and minimize cleaning and cleaning validation efforts….
Stem Cell Therapy Indications for Cardiovascular Disease in Phase II/III Clinical Trials
While there are stem cell therapies in development for several different indications, the number of therapies for cardiovascular disease indications is one of the largest. I have researched stem cell therapies that are in either Phase II or Phase III clinical trials in the United States for cardiovascular disease. For the purposes of this blog, I have only included information about ongoing trials or recently completed trials. I have not included trials that were stopped or were completed previously and have no future trials planned. While I have worked to include all current trials, please let me know if one is missing so that I may add it to the list….
Three vaccines in development are poised to make significant impact on global public health
Three vaccines that could have a major impact on global public health the Ebola vaccine, Malaria vaccine and Dengue Fever vaccine are working toward regulatory approval. As we are thankful that many other terrible diseases have either been either eliminated or brought under control by vaccines – small pox, rabies, measles, mumps, rubella, just to name a few; we also look forward to new vaccine targets that can also benefit public health in major ways….