Authors


STERIS Life Sciences

Latest:

Nephron Pharmaceuticals Integrates STERIS VHP Biodecontamination System

This case study examines the benefits and challenges Nephron Pharmaceuticals Corporation faced integrating a STERIS VHP® Biodecontamination system into their high-volume compounding facility.


Shilpa Jindani

Latest:

A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19

A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis


Patrick Adametz

Latest:

Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.


Mark Lies

Latest:

The Importance of Process Intensification and PAT for Achieving Real-Time Release

Creativity and collaboration are required to overcome complex method development challenges.



Hong Zhang

Latest:

Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.


René Hilmes

Latest:

The Quest for Quality: Challenges and Strategies in Raw Material Selection for Biopharmaceuticals

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.


Marc Bisschops

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.


Martin Gastens

Latest:

Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.


Bryan Thompson

Latest:

Demystifying Complex Clinical Trial Kit Prep

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.


Frédéric Kahn

Latest:

I Saw the Future of Global Pharmaceutical Production in India

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.


Datwyler

Latest:

“P.E.R.F.E.C.T.” the Packaging Selection Process

A step-by-step path to building confidence in packaging component selection for injectable drugs


Pfizer CentreOne

Latest:

Gene and cell therapy analytical and development methods: A path to success

Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.


Thorsten Strahl

Latest:

Detecting Residual HCPs Demands a Holistic Approach

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.


Adi Karisik

Latest:

Tackling Cybersecurity Challenges in Legacy Systems

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


Klaus Lindpaintner

Latest:

A New Era of Biomarker Discovery: Harnessing the Clinical Power of AI-Driven Glycoproteomics

Assessment of peripheral blood protein glycosylation has recently become scalable, providing a new domain for biomarker research.


Lucrèce Nicoud

Latest:

Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process Optimization

In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.


Emma Palmer Foster

Latest:

Perfecting the Pitch: Learning to Attract Investor Funding

Start-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.


Atul Khandekar

Latest:

A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19

A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis


Evan Zynda

Latest:

Addressing Cell Therapy Challenges Through a Modular, Closed, and Automated Manufacturing System

Scaling cell therapy production workflows requires the establishment of closed, automated steps.


Martin Glenz

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.


Stephen Carey

Latest:

Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.



Kerry Love

Latest:

The Optimal Metric of Space-Time Yield

Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.


Marie-Claire Beckers

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.



Chris Spivey

Latest:

A Look at CDMO–Biotech Partnerships and Tackling Complex Technical Challenges (BIO 2024)

Frontage Laboratories' Marianna Tcherpakov, PhD, director of Business Development, CMC Services, discussed the CDMO’s role in enabling startup biotechs solve complex technical challenges for scale up.


Jason Carmichael

Latest:

Predicting Extractables and Leachables from Container Stoppers

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.


Refeyn

Latest:

Streamlining AAV Characterization With Automated Mass Photometry

Webinar Date/Time: Thu, Dec 1, 2022 11:00 AM EST


Larry Bellot

Latest:

Best Practice Tech Transfer Methods for CGTs

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

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