Authors



Mollie Shields-Uehling

Latest:

Adapting to Opportunity

The biopharmaceutical industry must continuously evolve to keep up with changing trends.


Aaron Hammons

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Youssef Benchek

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Elina Gousseinov

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Karim Pirani

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Mikhail Kozlov

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Ling Bei

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.




Barney Zoro

Latest:

Micro-Scale Bioreactors in Fed-batch Microbial Screening

The author outlines key functional attributes to assess a small-scale model.


Kathleen Krafton

Latest:

Lean Changeover in Biopharmaceutical Facilities: Developing A Risk-Based Approach

A streamlined approach may enhance process efficiency and product quality.


David Deere

Latest:

Regulatory Reform in China: Implications for Global Biopharmaceutical Companies

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.


Dona York

Latest:

Generating a Fully Processed Antibody

The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.


David Rabuka

Latest:

Generating a Fully Processed Antibody

The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.


Abhishek Saharia

Latest:

Seeking Accelerated Biosimilar Characterization

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.


Naheed Sayeed-Desta

Latest:

Quality Metrics and CMO Agreement

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.


Ajay Pazhayattil

Latest:

Assessing Manufacturing Process Robustness

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.


Delia Lyons

Latest:

Perfusion in the 21st Century

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.


Bruce Lehr

Latest:

Perfusion in the 21st Century

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.


Roger van den Heuvel

Latest:

Disruptive External Factors Dictate Radical Internal Changes for Pharma

Pharmaceutical companies need to radically change to survive and thrive amid shifting healthcare and technology changes.


Timo Simmen

Latest:

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.


Stefan Merkle

Latest:

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.


Ranjit Thakur

Latest:

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.


Camal Handor

Latest:

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.


Ramanathan Venkataraman

Latest:

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.


Tatyana Mezhebovsky

Latest:

Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition Temperature

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.


Eric Routhier

Latest:

Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition Temperature

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.


Philip Sass

Latest:

Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition Temperature

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.


Christian Muller

Latest:

The Flexibility of Small-Scale Single-Use Bioreactor Solutions

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

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