Manufacturing

Review of SUT Adoption in Biopharma Manufacturing

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Automating the Future of Fill/Finish

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

PharmTech’s Weekly Roundup—September 25, 2026

September 25, 2026

Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.

CPHI Milan: USP Benchmarks Reshape Procurement Incentives

September 25, 2026

Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.

Weekly Basal Insulin Efsitora: A New Biologics CMC Benchmark

September 24, 2026

The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.

The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push

September 22, 2026

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

Inluriyo-Verzenio Combo Doubles PFS, Adds Oral Complexity

September 21, 2026

The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.

CPHI Milan Brings Back Leadership Summit as Supply Chain and Manufacturing Pressures Ramp Up

September 21, 2026

The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.

PharmTech Weekly Roundup—September 18, 2026

September 18, 2026

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.

Can AI Agents Satisfy CGMP Documentation Requirements?

September 18, 2026

Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.

Two Audit Case Studies Reveal the Cost of Incomplete Corrective Actions

September 16, 2026

PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.

Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs

September 16, 2026

The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.