Authors


Chester A. Meyers, PhD

Latest:

QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.


Frank Brello

Latest:

Fermentation Process Technology Transfer for Production of a Recombinant Vaccine Component

The authors describe challenges faced in transfer and scale-up of a fermentation process.



A. Imam

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.



J. Kuchibhatla

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


J. Brooks

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.




C. Velnoskey

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


K. Fritchman

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


S. Holdread

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


V. Weinknecht

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


Yann Pouliquen

Latest:

Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing

To select the right partner for media design and optimization services, several key factors must be considered.


Astrid R. Spain

Latest:

Patenting Biotechnology Inventions Will Become More Challenging

Recent patent rulings raise significant patentability questions for DNA sequence inventions.


Mark Witcher

Latest:

Multi-Purpose Biopharmaceutical Manufacturing Facilities Part 1: Product Pipeline Manufacturing

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.


Harry Silver

Latest:

Comparing Facility Layout Options for Managing Business and Operating Risks

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.


Munir N. Nassar

Latest:

Implications of Trace Levels of Redox-Active Metals in Drug-Product Formulation

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.



Nathalie Charland

Latest:

Plants As an Innovative and Accelerated Vaccine-Manufacturing Solution

A plant-based expression system could provide greater speed and capacity at a comparatively low cost.


Sartorius

Latest:

Pipette Calibration Matters: How to Perform an ISO 8655 Compliant Calibration?

As pipettes touch virtually every experiment, they influence the accuracy and repeatability of the experimental data.


Jesse Novak

Latest:

QbD in the Development of ADCs with PBD Dimer Warheads

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.


Sanjeevani Ghone

Latest:

QbD in the Development of ADCs with PBD Dimer Warheads

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.


Srinath Thirumalairajan

Latest:

QbD in the Development of ADCs with PBD Dimer Warheads

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.


Juliet Redhouse

Latest:

Patenting Antibodies in Europe

Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.


Monika Rai

Latest:

Patenting Antibodies in Europe

Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.


Martin Wisher

Latest:

Ensuring Viral Safety of Viral Vaccines and Vectors

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.


Anissa Boumlic

Latest:

Ensuring Viral Safety of Viral Vaccines and Vectors

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.


Damon Asher

Latest:

Ensuring Viral Safety of Viral Vaccines and Vectors

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.


Priyabrata Pattnaik

Latest:

Ensuring Viral Safety of Viral Vaccines and Vectors

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

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