Newsletter | September 13, 2021

09.13.21 -- QMS Maturity And Supply Chain Disruption

 
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VectorY: The Next Generation Of Pioneering Medicines

Amsterdam-based gene therapy company VectorY is developing vectorized antibodies to treat diseases of high unmet medical need with a specific focus on muscle and neuromuscular diseases.

Strategies To Achieve Success In Your Regulatory Inspection

An experienced CDMO can accelerate the regulatory inspection preparation and execution process by leveraging diverse regulatory knowledge, expansive technical capability, and global reach.

The Impact Of COVID-19: CDMO Capacity And Supply Chain Disruption

While many drug developers and manufacturers have raced to bring vaccines to the market, others have struggled with the scarcity of supply created by an overwhelming demand for the same resources.

Rapid Biosafety Testing Enables The Future Of Manufacturing

This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

How Scale Up Assist Helps Your Antibody Production Workflow

Using the BioFlo 720 Bioreactor Control System's Scale Up Assist feature to scale CHO batch cultures from 3 L to 10 L in single-use vessels and from 10 L to 50 L in single-use bioreactor bags.

Effective Downstream Purification: Clinical-Stage Retrovirus-Like Particles

Purification of enveloped viruses and virus-like particles is challenging due to their size and complexity. This study demonstrates resin screening, process development, and scale-up purification approaches. 

8 Misconceptions About Embedded CDMOs

Access to the expert capabilities of embedded CDMOs is offering great economies and competitive experience to the sector.

Attracting Top-Notch Employees In A Competitive Landscape

Immatics' Michael Mehler shares valuable insights into what it takes for emerging biopharmas to identify, draw, and retain an advanced therapy, development, manufacturing, and clinical workforce.

Media Selection: Impact On Performance Testing Of Poorly Soluble Drugs

Join Lonza Biologics' webinar on the design of dissolution media to support biopredictive dissolution testing to enable the development of bioavailability-enhancing formulations for poorly soluble drugs.

How CDMO Collaboration Impacts Sterile Injectable Product Success

Explore how a small or midsize biotech or pharma company can benefit from the experience and assistance provided by a CDMO with sterile injectables experience.

Lipid Formulations To Enhance Bioavailability In Early Development

To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

Principles Of Raman Spectroscopy For Pharmaceutical Development

Discover how Raman spectroscopy is used to analyze a chemical compound’s structure and how the technique is used to analyze amorphous material created through hot melt extrusion.

How To Select The Right Integrity Test Instrument

This guide will help you select the right integrity test instrument, including criteria that will allow accurate filter integrity testing that is fully compliant to current regulations.

Support Higher Growth And Plasmid Production In E. Coli

Read the results of a head-to-head comparison between Bacto CD Supreme FPM and Terrific Broth (TB), a traditional microbial medium.

Efficient Transition Of Human Pluripotent Stem Cell (hPSC) Cultures

This paper reviews the suggested method for adapting hPSCs originally cultured in StemFlex to NutriStem hPSC Medium to maintain similar morphology and higher levels of pluripotency.

Regulatory Services For Accelerated Development, Commercialization

The increase in breakthrough therapy designations and other allowances for expedited regulatory review has led to ever more innovative drug products being developed under shortened timelines.

Are You Protecting Employees During HPAPI Manufacturing?

Hazardous manufacturing controls expert Tom Evans, MS, CMMS, discusses production necessities for highly potent API (HPAPI) therapeutics while controlling the risk of exposure.

Rapid Cell Culture Media Analysis For Cell And Gene Process Development

Explore how to accelerate process analytics with fast nutrient screening at critical timepoints and the benefits of rapid media analysis in cell therapy development and viral vector production. 

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Be the first to hear about our latest addition to the Palltronic family as we introduce the Palltronic Flowstar V filter integrity test instrument.

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