Minaris Regenerative Medicine’s leaders and experts are proud to share their knowledge and insight with the cell and gene therapy industry. Please review our current and past blog posts on topics of interest to this emerging industry.
As our knowledge of human biology has grown, the newly found information has been leveraged to devise increasingly complicated treatments. This began with small molecule ...
When Robert Preti, PhD, co-founded PCT back in 1999, he already had extensive experience in stem cell processing and other roles from his time with the New York Blood ...
On Thursday, September 19, 2019, Dr. Robert Preti will join a panel of other cell and gene therapy industry luminaries to highlight the challenges that the industry is ...
As more cell therapy products reach the “finish line” of U.S. Food and Drug Administration (FDA) approval and new regenerative medicine products begin the clinical ...
The quality and consistency of starting material can have an enormous impact on downstream manufacturing processes in cell therapy. Recently, Hitachi Chemical partnered ...
The quality of starting materials can have an enormous impact on the potency, purity, and safety of a cell therapy product. Flaws in the collection or transportation ...
Phacilitate is the world’s largest advanced therapies partnering event, bringing together experts and solution providers from all over the world to create the perfect ...
In a recent Bloomberg Law article, Robert Preti, PhD, discusses how manufacturing bottlenecks are holding up cancer treatments from going to market. There has been a lot ...
A technology transfer (“tech transfer”) for cell therapy manufacturing is the transfer of knowledge, experience, specifications, procedures, and data for manufacture of ...
In a recent article, we discussed some of the major telltale signs that your cell therapy product might not be ready for a technology transfer. To be successful, a cell ...
Maintaining a sterile environment is an absolute must for maintaining product sterility in cell therapy manufacturing. Although the cost of building cleanrooms has ...
Product stewardship is a vital part of any cell therapy technology transfer and/or clinical development. The basic definition of product stewardship is the technical ...
The traditional method of achieving scale in manufacturing is, typically, to increase production capacity so that more product can be sold. For example, with medicines ...
Hitachi Chemical Advanced Therapeutics Solutions (HCATS) is proud to be an active contributor to the scientific research and publications surrounding the regenerative ...
Cell therapy products have started to gain significant traction in the pharmaceutical industry in the last few years because of the potential they possess to treat many ...
From helping prepare clients' cell therapy products for commercial-scale manufacturing to troubleshooting test methods for compliance with cGMP and cGTP regulations, ...
Dr. Robert Preti joins The Cell Culture Dish in advance of his upcoming keynote at CBI's Optimization of Cell and Gene Therapy Production Conference. The Cell Culture ...
One of the major challenges of delivering a patient-specific cell therapy is that fresh cells for modification are usually only viable for about one to three days from ...
Cell therapy is still a relatively new form of treatment. As such, not that many cell therapies have successfully reached commercialization. Meeting FDA requirements at ...
PCT services have helped many companies and research organizations develop their cell therapies from early-stage clinical trials into products ready for ...
The cost of goods (COGs) to manufacture a cell therapy can have an enormous impact on the long-term viability and sustainability of the therapy as a commercialized ...
As I contemplate the future landscape of this cell and gene-based medicine industry and how best it can be navigated, I am always less certain of precisely what the ...
At this year's Cell & Gene Meeting on the Mesa, Robert Preti, PhD, Chairman of the Alliance for Regenerative Medicine and President and CEO of Hitachi Chemical ...
Taking a new cell therapy from early clinical trials all the way to commercial manufacturing is a long and difficult process that few have completed to date. There are ...
Developing a new cell therapy is a long and arduous process. Many cell therapies fail to clear all of the obstacles on the road to commercialization. When considering ...
When referring to cell therapy, precision in your use of terminology is crucial for technical accuracy and reporting. There are many terms that have similar meanings but ...
In an interview published in the May 2017 issue of Drug Development & Delivery, PCT President Robert Preti, PhD, discusses PCT’s founding, differentiators, growth, ...
CAR-T cell therapy presents numerous challenges for cell therapy developers who are looking to move towards commercialization. The move from development to commercial ...
Cell-based therapies are rapidly changing the way the medical industry is treating a wide range of diseases. As the development of these therapies continues to advance, ...
One of the most critical first steps in the development of many cell therapies is having optimized apheresis collections. Starting with variable or low-quality apheresis ...
Despite the advances the cell therapy industry has made in recent years, commercially viable manufacturing continues to be an elusive challenge. In order for the cell ...
Cell therapies are at the forefront of saving lives – providing critical treatments to patients who might otherwise have very few viable options. Because these therapies ...
On Thursday, February 23 from 2:00 – 3:30 PM EST, Sanjin Zvonic, PhD, PCT’s Senior Director, Business Leader, Clinical Cell Therapy Manufacturing, will be speaking as ...
The following is an excerpt from a paper originally published online in the journal Cytotherapy on October 26, 2016, entitled, “Bioreactors for cell therapies: Current ...
The following is an excerpt of an article I wrote that was originally published in the October 2016 issue of The Medicine Maker. Some companies still fail to look beyond ...
While using cell therapies that have a short shelf-life due to a “fresh” final product (meaning the product is not designed for long-term storage) is perfectly ...
This is the third in a three-part series (read Part 1 and Part 2 for the complete picture). As you approach cell therapy commercialization—having traveled what is still ...
The following is a guest blog by Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions As forecast by the White House 2012 ...
This is the second in a three-part series (Part 1 can be found here). As you enter this mid-phase of development, we reflect on these words from Albert Einstein: “In the ...
PCT was recently featured in the BioProcess International Industry Yearbook. The article by Sanjin Zvonic, Ph.D., Director of Technology and Business Development for ...
It is no secret that patient-specific cell therapies are widely perceived to be expensive to produce, which leads to expensive products, if they commercialize at all. I ...
If you’re reading this, you’ve no doubt already discovered that cell therapy manufacturing comes with its share of specific challenges, no matter what phase of ...
Growing up, many of us became familiar with the children’s song, ‘The Bear went Over the Mountain’. In this nursery rhyme (of sorts) a bear that succeeds in scaling a ...
The following is an excerpt from an article published in the April issue of BioProcess international, entitled “Factories of the Future: Can Patient-Specific Cell ...
How do you develop and manufacture a cell therapy that is deliverable? What does it take to make a cell therapy commercially viable? To do so, it must be transformative, ...
The following is an excerpt from an article published in the April issue of BioProcess international, entitled “Factories of the Future: Can Patient-Specific Cell ...
In November 2014, Japan passed a new regenerative medicine law, the upshot of which is that it enables therapeutic development sponsors to receive conditional marketing ...
The following content, written by Thomas Heathman, MEng, PhD, Business Development Associate, PCT, was originally published on the blog of the website Technology ...
1. Why are T cells promising/exciting in cell therapy right now? What potential do you see? “T cells play a central role in the immune response, as they have the ...
The following post was originally published in the November 2015 edition of The Vector, the online newsletter for the American Society of Gene and Cell Therapy. Chimeric ...
Like an army, cell therapy marches on its stomach, and good supply chain management can (literally) keep it fed. However, the “soldiers” of cell therapy are the most ...
If you’re a striker (playing forward position) on a soccer team, you know that your primary role is to score a goal. But what makes you confident in your ability to ...
The following is an excerpt from an article originally published in the October issue of BioProcess International, written by:
The upcoming CAR-T Summit in Boston (November 12-13) is an opportunity for leaders from pharma, biotech and academia to get together to discuss “clinical strategy, ...
Automation is not just a buzzword. Automation—the act of taking laborious, manual steps of cell therapy manufacturing and making them more efficient through elimination ...
ISCT hosted a webinar, titled "Building Deliverable Cell Therapeutics: A Methodical Approach to Manufacturing Development," featuring experts from PCT on October 22, ...
At the end of this month, two of my colleagues and I have the opportunity to speak at the IBC Life Sciences Cell Therapy Bioprocessing and Commercialization Conference ...
The following is an excerpt of a commentary originally published in the September issue of DDNews, entitled, “Building a Problem or a Solution? : Removing the ...
Cell therapies armed with crafted weaponry in the form of CARs (Chimeric antigen receptors) and engineered TCRs (T cell receptors) have taken immuno-oncology to a new ...
Below is an excerpt on technology transfer in cell therapy manufacturing, written by Catherine McIntyre, PhD, Director, Technical Operations, and Cenk Sumen, PhD, ...
As discussed in my previous post, FDA has provided guidance via ICH Q8 for pharmaceutical development (where Quality by Design (QbD) principles are presented) for ...
Below is an excerpt on technology transfer in cell therapy manufacturing originally published in the April 2015 issue of BioProcess International as part of the article, ...
Before any cell therapy company can begin manufacturing a therapy, or designing and engineering the production equipment, it is necessary to engage in detailed ...
PCT experts Robert Shaw, VP, Commercial Development; Brian Hampson, VP Manufacturing Development & Engineering, and Candice Betz, Director of QA/QC, have recently ...
By Sanjin Zvonic, PhD, Director, Technology & Business Development
By Sanjin Zvonic, PhD, Director, Technology & Business Development
By Sanjin Zvonic, PhD, Director, Technology & Business Development
By Sanjin Zvonic, PhD, Director, Technology & Business Development
2012 marks the 20th anniversary of the formation of the International Society for Cellular Therapy (ISCT). ISCT was first conceived by a handful of pioneers at a ...
PCT's Dr. Sanjin Zvonic, drawing on more than 12 years of PCT's philosophy, experience and expertise, gives an overview of the key steps in the commercialization of cell ...