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The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization

For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration.

EDITOR'S DESK

Easing Autologous Cell Collection, Automating Manufacturing
To circumvent the challenges of leukapheresis, CellProthera developed a novel method for collecting therapeutic stem cells from whole blood. CSO Ibon Garitaonandia, Ph.D., discusses the company's mission to streamline manufacturing.

Industry Leaders On Analytical Method Development

Experts from Bristol Myers Squibb and Moffitt Cancer Center discuss best practices for analytical method development, as well as how to manage the successful transfer of these methods.

Optimism For Biopharma In 2025

In this closing segment from the executive roundtable discussion, our panelists express their confidence in the industry's mission and maintain a positive outlook for the years ahead.

How Biotechs Can Navigate Market Uncertainty In 2025

In this segment of the executive roundtable discussion, our panelists weigh in on how to prepare for what may be a challenging financial climate in 2025.

Political Influences And Regulatory Implications For Biotech In 2025

In this segment of the executive roundtable discussion, our panelists discuss the changing political landscape and its potential effects from a regulatory and economic point of view.

GUEST COLUMNISTS

3 Strategies For mAb Manufacturing: How Do You Choose?
As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.
A Practical Guide To Defining Priority Data In MES
Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.
How Is The Market Responding To Brisk HPAPI Demand?
The rise of precision medicine like ADCs has created new markets for highly potent API. More suppliers are building out capacity to meet the demand.
Do Patient Needs Define Biologic Product Specifications?
Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.
Are CDMO Partnerships The Answer To Manufacturing Capacity Issues?
The current manufacturing strain is exacerbated by factors such as the intensity of scaling up fill-finish and specialized manufacture of drug delivery devices. How can partnering with a CDMO help?
A Snapshot Of What Pfizer's Doing With Teleoperated Robots
A robotic arm controlled with a virtual reality headset and input devices could aid in complex interventions where automation isn't practical.
Retrofitting Facilities For Modern Bioprocessing And Pharma Production
The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.
MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs
The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

BIOPROCESSING WHITE PAPERS

Solving Cost And Supply Challenges In Biopharma Downstream Processing
In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.

Centrifuges Transforming Biopharmaceutical Development And Manufacturing
5/23/2023

Single-use centrifuges have the potential to become the new bioprocessing standard, helping manufacturers meet the need for innovative production methods when facing emerging modalities and next-generation biotherapeutics at scale.
The Key To Accelerating RNA-LNP Drug Development
12/27/2023

Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
Microbial Challenge In-Use Studies
6/13/2024

Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing
9/1/2023

Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics.
Developing Effective Procedures
10/21/2024

Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.