June 17th 2025
The Purolite AP+50 affinity chromatography resin has a 50-micron bead size that offers dynamic binding capacity of the AP resin platform while providing durability for monoclonal antibody capture.
June 8th 2025
A continuous biomanufacturing platform can process higher/lower quantities of a drug as needed and allow manufacturers to respond to changing markets.
May 6th 2025
Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.
March 8th 2025
The benefits include reduced contamination risks, simplified validation processes, and streamlined operations.
December 5th 2024
Many factors must be considered to overcome the challenges associated with viral clearance.
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Upstream, Downstream Processing in Motion
GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing.
The Challenges of Adopting Single-Use Technology
Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.
A 25-Year Retrospective on Protein Recovery through Membrane Filters
This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years.
It's an Election Year.... Are You Making the Best Choices in Single-Use Tubing
The author considers the types of tubing available to the industry and how to make an informed selection.
EU Sets Guidelines for Biosimilar mAbs
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.
Downstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting a downstream process.
A 25-Year Retrospective on Bioprocessing mAbs
Michiel E. Ultee of Laureate Biopharmaceutical Services gives an update on 1988 article regarding virus testing and how the advance of monoclonal antibodies has changed processes.
In-Depth Validation of Closed-Vial Technology
The authors describe a validation master plan for closed-vial filling technology.
A 25-Year Retrospective on Bio-Engineering
Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."
Biomanufacturing Innovation
Industry wants more innovation, but can suppliers meet customers' needs?
25 Years of Nanoparticles: A Look Forward
Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.
25 Years of BioPharma Industry Growth
A review of key industry shifts and promises for the future.
25 Years of Biopharmaceutical Innovation: An Expert Roundtable
Industry experts discuss significant achievements. Plus: What's in store for the future.
Optimizing Drug Delivery for Modern Biologics
This article discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.
Development of an Alternative Monoclonal Antibody Polishing Step
MAb polishing using salt tolerant interaction membrane chromatography.
Pointed Debate
Industry experts discuss the benefits and challenges of self-administration of injectable therapies.
Optimizing Adjuvant Filtration
A technical rountable featuring Sartorius Stedim Biotech, Pall Life Sciences, 3M Purification, Asahi Kasei Bioprocess, and Bio-Rad Laboratories.
Single-Use Redundant Filtration
The authors describe a new assembly for bulk and final drug product filling operations.
Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use Bioreactor
Demonstration of large-scale stem-cell scale-up.
Recombinant Albumin Facilitates Formulation Design of Stable Drug Products
Recombinant albumin can stabilize a drug product and assist in API release.
The Drive for Best Practice in Biopharmaceutical Manufacturing
Key business considerations when developing biosimilar products virtually.
Assessing Filling Technologies For Contamination Risk
The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.
Therapeutic Vaccine Outlook
Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?
A 25-Year Retrospective on Separations Technology
This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity."
An Overview of Risk Assessment Strategies for Extractables and Leachables
Approaches for risk assessment of extractables and leachables.
Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)
The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
Efficient Prion Removal from Gonadotropin Solutions by Nanofiltration Membranes
Can a nanofiltration process be leveraged for removal of prions?
The Employment Outlook Brightens
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
Approaches for Flexible Manufacturing Facilities in Vaccine Production
With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.
Challenges and Trends in Vaccine Manufacturing
An evaluation of the technologies needed to develop a safe, effective, and economically efficient vaccine. This article is part of a special section on vaccines.