BPI White Papers

RFID is the New Weapon in the Fight Against Counterfeiting

Counterfeit goods cost the economy up to $250 billion a year, with U.S. Customs and Border Protection agents seizing nearly $80 million in counterfeit pharmaceuticals and personal care products in one year alone. The World Health Organization (WHO) reports that 200,000 people die each year due to ineffective and substandard (counterfeit) malaria drugs. The WHO also reports similar issues in the medical device market. In 2010, over 8% of devices in circulation were counterfeit and that number increased by 50%…

Culture of 3D Cell Aggregates in Perfusion in a DASbox® Mini Bioreactor System

Three-dimensional (3D) cell aggregates are of great interest for many applications, including disease modeling, drug toxicity assessment, and manufacturing of stem cell-based products. Stirred-tank bioreactors are promising culture systems for 3D cell aggregates, as they allow efficient establishment and maintenance of cell aggregates, process monitoring and control, and process scale-up to larger volumes. Furthermore, they can be operated in perfusion mode, which allows 3D cell aggregates to be sustained longer than in traditional batch cultures. Researchers at the Instituto de…

Top 10 Human Tissue Supplier Considerations for Allogeneic Cell Therapy Development

The rapidly developing global cell therapy market poses numerous industry challenges for drug development, process scalability, commercialization, and patient safety. The processes of procuring human tissue for clinical applications are fraught with many technical, ethical, and legal issues. Allogeneic cell therapies involving primary cell types such as bone marrow mesenchymal stromal/stem cells (BM-MSCs), hematopoietic stem and progenitor cells (HSPCs), and T and NK cells for immunotherapy applications are especially challenging due to the vigorous process of screening and qualifying human…

Assuring Multipotency of human Mesenchymal Stem Cells (hMSC)

Over the past decade, stem cell research has provided new avenues for deeper investigation into tissue repair and aging processes, as well as regenerative medicine methods. One of the major players in such research endeavors are mesenchymal stem cells (MSC), also known as mesenchymal stromal cells. MSC are typically found in bone marrow, adipose, placental, and umbilical cord tissues1 and are a type of adult stem cell. In vivo, these cells are headquartered in special microenvironments or “niches” in the…

Cell & Gene Therapies: A Guide to Single-Use Connections. 10 Transferable Lessons from the Bioprocessing Industry

It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up

In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale up or scale out philosophy is used. The industry standard has been to scale up, which translates to increasing the size of the bioreactors used in manufacturing runs. However, due to the recent availability and ease of single-use technologies, coupled with improvements in cell culture…

We Meet Your Single Use Process Monitoring Requirements

Innovation is at the core of all pharmaceutical, biopharm and bioprocess applications. With extensive experience in the biopharmaceutical industry — and particular expertise in single-use bio-pharmaceutical equipment — PendoTECH delivers a line of pressure sensors, control systems and software for measuring, monitoring and data collection in bioprocess applications and other areas where the products provide a unique process solution. Committed to meeting the specialized needs of life-science laboratories and bio-pharmaceutical manufacturers, PendoTECH technical consultants review your company’s applications in the…

Digitization of Biology to Revolutionize Lab Productivity

Biological research is limited by a technical barrier that exists between scientists and lab hardware. Each piece of hardware has its own software, its own file format and its own eccentricities, which the user needs intimate familiarity with to get the most from the machine. Using Antha, a user-friendly but hugely powerful software platform, gives biologists sophisticated, flexible and integrated control over lab hardware. This enables experiments and lab workflows to be rapidly automated, with data automatically integrated and linked…

Single-Use Automation: Unlocking the True Potential of Single-Use Technology

When single-use technology first arrived on the scene in the late nineties, the processes that it was applied to were relatively simple and low risk. These included simple filtration and storage applications of buffers and cleaning solutions. With these filtration steps typically involving lower value, non-blocking solutions of easy to dissolve salts, automation would have been seen as an unnecessary over- complication. It was thought sufficient to have an operator watch the process to make sure nothing became disconnected, a…

Isolator advantages in Cell Therapy Production

With numerous cellular and gene therapy products seeing strong initial clinical successes, investment in next-generation technologies by both large bio/pharma companies and start-up specialist firms has been significant. In fact more than 750 companies worldwide declare themselves to be in the “regenerative medicine” market space, with a high percentage of year on year increases in the number of cellular and gene therapy drugs in clinical trials. Many of these companies are eager to advance from early stage clinical trials to…