ARTICLES BY TRISHA GLADD
Scale-Up Of Autologous Cell Therapies Realized Through Technological Collaboration
The autologous cell therapy market is experiencing tremendous growth, but under the current system for manufacturing these products, companies struggle to get a return on their investments. However, a recent partnership between Octane and Lonza may finally offer a cost-effective solution to scale-up that could give companies new hope for commercialization.
How Can You Mitigate The Risks Of Single-Use Bags?
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
Making The Switch To Single-Use: Have You Thought Of Everything?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
Untapped Potential Of Protein A To Be Highlighted At BPI Conference
Pete Gagnon, group manager for downstream processing at the Bioprocessing Technology Institute in Singapore, discusses his upcoming presentation at the 2015 BioProcess International (BPI) Conference. Protein A: the Fine Print, is one of several scheduled during the pre-conference symposia track, Innovation in Process and Product Development Technologies for Biopharmaceutical Development.
Is Sustainability Possible With Single-Use Technology?
At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?
AGA Survey May Indicate Pharma’s Acceptance Of Biosimilars
A recent survey by the American Gastroenterologist Association (AGA) reveals that while biosimilar manufacturers are still battling challenges in order to bring these drugs to market, at least some members of the medical community will welcome them with open arms once they’re available.
Federal Ruling Offers Some Regulatory Clarity For Biosimilars
On July 21, 2015, the Federal Circuit reached a momentous decision in the case of Amgen vs. Sandoz. The significance of this ruling goes well beyond the rights of these particular manufacturers, as the decision marks the first step toward clarifying the regulatory path for U.S. biosimilar manufacturers.
Advances In Science Could Give Way To Limited NIH Funding
Funding allocated to the National Institute of Health (NIH) has declined considerably over the last decade, particularly the last five years, despite the fact that the cost of conducting biomedical research has gone up. Without budget predictability, the NIH is now forced to be very conservative with grants. This is where we could see a significant impact to both the pharmaceutical industry and patients.
First Commercial-Scale ADC Facility Launches In North America
As of last month, there are a total of 264 antibody drug conjugates (ADCs) in pharma’s pipeline. 161 of those are being developed in North America, making it the continent with the highest number of ADCs in development. Despite this, there is not a company currently offering ADC manufacturing capacity through commercial scale in North America. However, this will no longer be the case by the end of this year.
3 Critical Considerations For Cell Therapy Manufacturing
While autologous cell therapies offer promise in the way of patient treatment, manufacturing them is a complex process requiring thorough understanding of the cell type(s) that a company will be providing as therapy. When it comes to ensuring the successful manufacturing of a cell therapy drug, Ross Tubo, chief scientific officer at Vericel Corporation, says there are three critical areas where particular attention should be paid.