Revolutionary Cold Chain Management built on Global Reach and...
Reliable cold chain management is more critical than ever in today’s fast-paced and interconnected supply chains, especially in the biopharmaceutical, food, and life sciences sectors. With our...
View ArticleThe Importance of a Strategic Cold Chain Executive in your BioPharma Company
The biopharmaceutical industry faces a myriad of complex challenges in the delivery of life-saving drugs and vaccines, particularly in ensuring their quality and efficacy during transportation and...
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Melinta Therapeutics announces FDA approval of REZZAYO™
Congratulations to Melinta Therapeutics for their FDA Approval of REZZAYO for the Treatment of Candidemia and Invasive Candidiasis. Melinta Therapeutics came to Modality Solutions for cold chain...
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Vertex announces UK approval for CASGEVY™
Congratulations to Vertex for their UK approval for CASGEVY, a CRISPR/Cas9 gene-edited therapy, for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). We are...
View ArticleCold Chain Executive: How to be a Leader Instead of a Follower
The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical leader is that you don’t need to know every detail about the underlying engineering, mathematical...
View ArticleNavigating New Regulatory Seas: Biopharma’s Critical Shift in Biologic Drug...
The biopharmaceutical industry is at a pivotal moment, particularly those involved in developing drugs for rare diseases. The recent guidance from the FDA on “Rare Diseases: Considerations for the...
View ArticleA Cold Chain Process Validation Guide: Introduction to Cold Chain Process...
Introduction The integrity of cold chain management is pivotal in the demanding realm of pharmaceutical and biologic industries. This six-part article series explores Cold Chain Process Validation,...
View ArticleA Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain...
Biopharma supply chain excellence starts by integrating your cold chain. By integrating your cold chain, you ensure that all the processes work together to achieve a common goal – to deliver quality...
View ArticleUnlocking FDA Insights: Exploring Open Data Files for Shipping Validation
Are you aware of the open data files published online by the FDA? This wealth of information includes redacted versions of CMC reviews, meeting minutes, Summary Basis for Regulatory Action letters,...
View ArticleA Cold Chain Process Validation Guide: Part 3: Developing Mature Quality Systems
Developing mature quality systems is one of the biggest challenges and one of the most effective tools to manage a world-class cold chain logistics network. Making them work for you, and not the other...
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