In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved and uniform product quality, lower capital cost, and easy scale-ups. The primary focus, thereby, lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address the dynamically changing conditions.
- Model-Based Control In Continuous Manufacturing of Biotherapeutics
- Marks Took On FDA Vaccine Leadership Position – What Happens Now?
- Calculating The Process Capabilities Of Cleaning Processes: A Primer
- Benefit Design In Medicare Exacerbates Vaccine Access Inequity
- The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials
- Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
- Updated Orange Book/Biologic Patent Study: Key Learnings
Model-Based Control In Continuous Manufacturing of Biotherapeutics
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
Marks Took On FDA Vaccine Leadership Position – What Happens Now?
Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.
Calculating The Process Capabilities Of Cleaning Processes: A Primer
The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes.
Benefit Design In Medicare Exacerbates Vaccine Access Inequity
Vaccines are widely regarded as the most cost-beneficial intervention in healthcare. Unfortunately, and counterintuitively, current cost-sharing policies discourage our most vulnerable population – seniors – from accessing vaccines.
The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials
While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques.
Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
Updated Orange Book/Biologic Patent Study: Key Learnings
Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.
BIOSIMILAR WHITE PAPERS
How Buffer pH And NaCl Affect Size Exclusion Chromatography
Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.
Secure The Cell Therapy Supply Chain From Bench To Bedside10/4/2021
Here, we consider the challenges and risks associated with the cell therapy cryogenic supply chain and provide considerations for mitigation strategies.
Standardizing Vein-To-Vein Logistics To Reach More Patients2/24/2020
Collaboration is key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.
Can mRNA Disrupt The Biopharma Industry?6/10/2020
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
Strategies For Upstream Intensification8/14/2020
Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!
The Role Of CDMOs In Cell And Gene Therapy Process Development8/5/2020
This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.