Cell and Gene Therapy Archives

Direct-to-Patient Shipments: What I Said in 2021 — and What We See in 2026

Developing biosimilars involves navigating complex manufacturing and regulatory challenges that go far beyond traditional generics. This guide explores key hurdles—from analytical characterization to large-scale production—and highlights how strategic CDMO partnerships help ensure similarity, scalability, and commercial success.

Columns, Features, Sectors
Lyophilization Cycle Development for Biologics: Critical Parameters CDMOs Must Optimize

Developing an efficient freeze-drying cycle requires deep expertise in thermodynamics and protein chemistry. This 2500-word guide explores the lyophilization parameters for biologics that CDMOs must optimize to maintain potency. Learn about critical temperatures, vacuum levels, and strategic scale-up considerations for high-value biopharmaceutical manufacturing.

Manufacturing and Operations
Continuous vs Batch Blending in Pharma: GMP, Risk, and CDMO Selection Explained

Deciding between continuous vs batch blending is a pivotal moment for drug product development. This 2500-word guide provides expert analysis on technical risks, GMP validation, and strategic CDMO selection. Explore how Process Analytical Technology (PAT) and modern engineering are transforming oral solid dosage manufacturing for global biopharma sponsors and manufacturers.

Manufacturing and Operations
Spray Drying ASD Scale-Up: What Sponsors Must Know Before Choosing a CDMO

Transitioning from lab to commercial volumes in spray drying ASD scale-up requires a deep understanding of thermodynamics and polymer science. This 2500-word guide explores how sponsors can navigate the complexities of Amorphous Solid Dispersions (ASDs), manage solvent risks, and select a CDMO that ensures long-term stability and regulatory compliance for poorly soluble drugs.

Manufacturing and Operations
Regulatory Guide for Shipping Pharmaceuticals Internationally by Sea and Air

International shipping of pharmaceuticals requires strict adherence to regulatory frameworks. This guide explains how to ship pharmaceuticals by sea and air while staying compliant with GDP, customs, and documentation requirements, with examples of top shippers and technology solutions.

Sectors, Supply Chain and Logistics
When to Outsource Biologics Manufacturing

Deciding when to outsource biologics manufacturing is a critical milestone for biotech sponsors. This guide explores the strategic triggers—from capital constraints to specialized technical needs—that drive the transition to CDMO partnerships, ensuring faster clinical timelines and reduced operational risk in the large-molecule market.

Biotech, Insights, Manufacturing and Operations, Outsourcing, Sectors
Quality Agreements Between Sponsors and CDMOs: Key Clauses to Include

Establishing robust quality agreements pharma cdmo is a regulatory necessity that defines the division of responsibilities between sponsors and manufacturers. This 2500-word guide explores essential clauses, from audit rights to deviation management, ensuring your partnership meets FDA and EMA standards. Learn how to mitigate risk and protect your product's integrity through strategic documentation.

Legal and Regulatory
Biosimilar Manufacturing Challenges: Why CDMO Partnerships Matter

Developing biosimilars requires navigating a labyrinth of technical and regulatory hurdles. This comprehensive guide examines the most pressing biosimilar manufacturing challenges, from analytical characterization to large-scale production. Discover how strategic CDMO partnerships provide the specialized expertise and infrastructure necessary to achieve analytical biosimilarity and commercial success.

Biotech
Contract Manufacturing for Sterile Injectables: What Sponsors Need to Know

Navigating the complexities of contract manufacturing sterile injectables requires a deep understanding of aseptic processing, fill-finish technology, and rigorous GMP compliance. This 2500-word guide provides sponsors with essential insights into selecting the right CDMO, managing technical transfers, and ensuring sterility assurance for high-value biologic and small molecule injectables.

Manufacturing and Operations
CDMO Strategies for Drug-Device Combination Products: Navigating FDA Regulatory Pathways

Navigating the regulatory landscape for drug device combination products requires a dual focus on pharmaceutical and medical device standards. This comprehensive 2500-word guide explores CDMO strategies for managing FDA 21 CFR Part 4 requirements, risk management (ISO 14971), and human factors engineering. Learn how to optimize your submission strategy and ensure market success for innovative combination therapies.

Medical Technology