Manufacturing

This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.

The IMA Pharmaceutical and MedTech divisions will be highlighting the TILE-X fill-finish line, a new VPHP BioIndicator, X-PEN autoinjector platform, and a range of machines from its IMA Active, IMA Life, IMA Safe, and IMA BFB divisions at the CPHI Milan event.

In commercial tablet or capsule operations, validation helps protect the site’s ability to produce, release, and supply product without repeated disruption. This article discusses validation as a technical control system that supports manufacturing continuity.

This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.

Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, provides a preview of the new Sustainability Summit at CPHI Milan 2026.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

Nitrosamine control is about understanding why nitrosamines form, where they may form, and how to prevent their formation.

Lilly is set to acquire Merida Biosciences for up to $2.875B, gaining a precision autoantibody-degrading platform led by phase 1 candidate MER511.

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

European biotechs are advancing bioinks and high-resolution bioprinting for medical devices and regenerative tissues.

McKesson will acquire Precision Medicine Group for $2.25B, integrating clinical research and commercialization services within its oncology segment.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

Samantha Hadfield, PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.

A dual-delivery capsule platform delivers multiple APIs in a single dosage unit, reducing pill burden and simplifying dosing regimens.

Glenn Herring, Halo Pharma, discusses its new sterile fill-finish platform: Groninger/SKAN tech, GMP design, and 2026 qualification timeline.

In part 2 of this 2-part interview, Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, tells PharmTech about the challenges in achieving sustainability in pharma and how the CPHI Sustainability Summit, which launches at CPHI Milan 2026, can help organizations tackle these challenges.

This week, a $2.3 billion manufacturing campus and a new fill-finish platform signal capacity is crucial; AI in pharma is still evolving; and CPHI Milan previews a new Sustainability Summit.

Lee Karras, CEO, Halo discusses the company's new sterile fill-finish platform, Apotex partnership, and injectable onshoring strategy.

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

PharmTech spoke with Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, about the new Sustainability Summit that will launch at CPHI Milan 2026 and how it can help organizations obtain measurable, commercially viable solutions for sustainability in the pharma industry.

Pen injector pre-assembly demands 160 PPM precision: LVDT/vision systems, tolerance control, and GAMP5 challenge testing ensure ISO 11608 compliance.

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

Glenn Herring, Halo Pharma, details the CDMO's new sterile fill-finish platform, Groninger/SKAN tech, GMP/Annex 1 design, and 2026 qualification timeline.