Authors


Phil Felgner, PhD

Latest:

The First Optimized Self-Replicating RNA (srRNA) Technology

This inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.




Brian Greven

Latest:

Innovations and Trends in Aseptic Manufacturing Processes

The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.


CPHI Frankurt Content Team

Latest:

CPHI Frankfurt: Selecting the Right Outsourcing Strategy and Partner

Sponsors should explore key considerations ahead of choosing a new outsourcing partner.



James Klingelhoefer

Latest:

Evaluating CMO/CDMO End-to-End Expertise: The Importance of Standardizing Cold Chain

Conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.



Melody Trexler-Schmidt

Latest:

Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.


Amit Paz

Latest:

Simulations Improve Production Capacity

As biotechnology organizations have successfully launched new products, the challenges of producing adequate quantities have grown. Many companies are now dealing with multiproduct manufacturing facilities and pushing the limits of their capabilities. One result of this complexity is a loss of production capacity due to inefficiencies.


Sandy Weinberg, PhD

Latest:

Funding Biodefense Vaccine Development

Biodefense start-up companies have an abundance of options when seeking funding.



Kristin Thomas

Latest:

The Development and Application of a Monoclonal Antibody Purification Platform

A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.




Kim Thomas

Latest:

Connecting the Manufacturing Process to Patient Wellness

Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.


Amardeep Bhalla, PhD

Latest:

Disposable Bioreactors for Cells and Microbes

Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.


Carlos A. Dominguez

Latest:

Improving Tangential Flow Filtration Yield

Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.



Millie Ullah, PhD

Latest:

Disposable Bioreactors for Cells and Microbes

Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.


Binh Q. Thai

Latest:

Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.


Nathan Pease

Latest:

A Case Study of Developing Analytical Methods

Contract manufacturers must plan for increased analytical resources in development and quality control.



Brian Kelley

Latest:

Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.


Genesio Murano

Latest:

Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?

In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.



Guido Stroehlein, PhD

Latest:

Increasing Capacity Utilization in Protein A Chromatography

A twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.




Mark DeLuca

Latest:

Final Word: Beware of Patent Infringement During Discovery Research

Experimenting with a rival?s patented compound may land you in hot water.

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