03.31.26 -- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes

Rising demand for complex TIDES therapies is shifting manufacturing expectations, driving adoption of continuous processing, digital tools, stronger supply strategies, and greener, scalable synthesis.

Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

As demand for GLP-1s and biologics accelerates and timelines compress, it's become more crucial that companies stay competitive and bring therapies to market faster by partnering with a CDMO.

Segments increase press output by up to 25% and cut setup time by 88%. Learn the benefits, drawbacks, and manufacturing needs of this rapidly growing tablet press technology.

Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

Product recalls impact revenue and reputation. Implementing inspection systems like X-ray, vision inspection, and metal detection helps prevent contamination and regulatory issues.

Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.

Powder filling creates intrinsic particles that interfere with continuous monitoring. Risk‑based strategies must separate product dust from true contamination to meet Annex 1 requirements.

Thermal analysis reveals how particle size and morphology influence material interactions and stability. See how DSC and MDSC techniques uncover compatibility issues and guide better excipient selection.

A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

Manufacturing complex and highly potent ADC treatments presents unique challenges. Get an insider look at how these treatments make it from development to commercialization.

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

Examine five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success.

A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

Uncover a UPLC-UV method using Empower 3 Software to assess synthetic peptide purity, as well as how integrated tools streamline impurity tracking and compliance in peptide analysis workflows.

Move beyond reactive firefighting by prioritizing disciplined leadership and data-driven milestones. The winning model for complex programs is focused, high-maturity, low-drama execution.

As the number of highly potent drugs in development and on the market increases, regulatory expectations continue to evolve. Review the regulatory considerations for today’s highly potent products.