Biopharma Cold Chain Resources

Whether you’re new to cold chain regulatory requirements or a seasoned expert in shipping validations, Modality Solutions offers expert perspectives on the biopharmaceutical cold chain industry.

Cold Chain Executive: The Difference Between Biopharmaceutical Cold Chain + Supply Chain Strategy

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

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Cold Chain Engineering Pharmaceutical

Cold Chain Executive: The Difference Between Biopharmaceutical Cold Chain + Supply Chain Strategy

Incyte announces FDA approval for Zynyz™

Congratulations to Incyte on their FDA approval for Zynyz™, a treatment for adults with metastatic...

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Press Release

Incyte announces FDA approval for Zynyz™

Amicus Therapeutics announces EC approval for Pombiliti™

Congratulations to Amicus Therapeutics for their European Commission approval for Pombiliti™ in patients with Late-Onset...

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Press Release

Amicus Therapeutics announces EC approval for Pombiliti™

Acadia Pharmaceuticals, Inc. announces FDA Approval of Daybue

The team at Acadia Pharmaceuticals Inc. announced FDA Approval on their drug Daybue, for...

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Press Release

Acadia Pharmaceuticals, Inc. announces FDA Approval of Daybue

Atara Biotherapeutics Announces EU Approval

The team at Atara Biotherapeutics announced EU Approval on their allogeneic T-cell therapy to treat adult...

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Press Release

Atara Biotherapeutics Announces EU Approval

Is it Necessary to Perform Analytical Testing After PQs?

Executive Summary: As clients choose Modality Solutions as their trusted cold chain consultants and...

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Regulatory Filing Transport Sim Transport Simulation

Is it Necessary to Perform Analytical Testing After PQs?

Specialized Global Regulatory Expertise

Read the rest of our regulatory expertise series below: Part I: A History of...

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Regulatory Filing

Lane Bracketing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

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Cold Chain Engineering Emerging BioPharma Pharmaceutical

Lane Bracketing: How to Implement ISTA’s PCG-03 Recommendations

Scope & Timing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

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ASTM/ISTA

Scope & Timing: How to Implement ISTA’s PCG-03 Recommendations

What Makes Modality Solutions Your Cold Chain Regulatory Experts?

Staying on Top of Regulatory Trends Modality Solutions is constantly scanning the environment for...

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Regulatory Filing