Authors


Lyufei Chen

Latest:

Extracellular Vesicles and Fluorescence Excitation-Emission Matrix Spectroscopy

Fluorescence spectroscopy offers unique advantages for characterizing EVs.


Emergent BioSolutions

Latest:

Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.

***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.


SGS Health Science

Latest:

Changing regulatory environment for nitrosamine impurities

This SGS Health Science whitepaper uncovers the changing regulatory environment, and the challenges posed by the detection of nitrosamine impurities in drug products.


Rajesh Ullanat

Latest:

Using Modeling to Improve Data Analytics for Upstream Bioprocessing Workflows

Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.



Emergent CDMO

Latest:

4 Steps for a Smooth Tech Transfer When Working with a CDMO (Nov 2023)

When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.


Verena Oeinck

Latest:

Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility Study

Continuous SEC was shown to increase productivity with the same product quality and yield.


MasterControl

Latest:

QMS Buyer's Guide

Quality management is inherently complex. That’s why you need QMS software that’s suited to your company’s unique needs. This comprehensive resource shows you the key quality management software features to look for and ways modern tools can give you an edge today while paving the way for success tomorrow. Wherever you are on your buyer journey, the foundation provided in this guide will help you make the right choice.


Khanh Ngo Courtney

Latest:

Selecting the Right CMC Strategy for Biologics

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.


Satyendra Suryawanshi

Latest:

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.


Koottala S. Ramaswamy

Latest:

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.


Robert Brokamp

Latest:

Tackling Cybersecurity Challenges in Legacy Systems

Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.


Jon Weston

Latest:

Formulating Autologous Therapies for Cancer

Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.


Mike Hennessy Jr.

Latest:

Inspiring Developments

Science is propelling advances and operational shifts in the bio/pharmaceutical industry.


Pierre Boulas

Latest:

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.


Yokogawa Electric Corporation

Latest:

Leveraging Data for Predictive & Real-time Bioprocess Performance Improvements

Thu, Sep 8, 2022 11am EST | 8am PST | 4pm BST | 5pm CEST Digitalization & leveraging real-time data are key for biopharma process improvement. Insilico models and soft-sensors boost biopharma performance to unprecedented levels.


Univercells Tech

Latest:

Scalable seed train intensification and automation for adherent cell cultures

This application note explores the feasibility of utilizing the scale-X carbo bioreactor as a solution for seed train intensification.


Stefan-Julian Frohberger

Latest:

Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part I: Facility and Cleanroom Cleaning Practices

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.


Jay Harkins

Latest:

Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems

This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.


Hari Narayanan

Latest:

Advancing Enzyme Analysis

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.


Julie Barthuet

Latest:

Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.


Alexander Rodriguez

Latest:

Development Strategies for Cell and Gene Therapy Methods

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.


Jennifer Devine, JD

Latest:

Public Trust in Medicine Quality as Public Health Challenges Emerge

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.


Maurizio Valleri

Latest:

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.


Dayna Turner

Latest:

Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.


Rockwell

Latest:

The Facility of the Future

Critical considerations for deploying smart, fast, and flexible Life Sciences facilities


Jane Weitzel

Latest:

Evolution of Analytical Procedure Validation Concepts: Part II

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.


Neh Nupur

Latest:

Emergence of India as a Global Manufacturing Hub for Biosimilars

The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.


Prashant Pokhriyal

Latest:

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.


Constanze Blume, PhD

Latest:

The Future of Manufacturing, Safety, and Collaboration

The panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.

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