Latest

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

Leslie Weaver and George Hunt, IPS, explore how design for disassembly and lean thinking are transforming the way pharmaceutical facilities are built and scaled.

Avi Nandi, SK Pharmteco, discusses how on-site media and buffer manufacturing can simplify supply chains and de-risk cell and gene therapy production.

Todd Vaughn and Christa Myers of CRB discuss how robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

Maria Batalha, Valgenesis, discusses how a centralized digital platform unified drug substance data from R&D to commercial manufacturing, enabling smarter, FAIR-compliant pharma operations.

Ryan Kelly, Rx360, shares expert strategies for mapping, auditing, and protecting pharmaceutical supply chains to ensure global patient safety.

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

Stuart Tindal and David Chau discuss spectroscopic sensor selection for continuous bioprocessing and how industry collaboration drives shared innovation.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

Richard Sanderson, IPS, discusses pharma capital project cost pressures, bloated deliverable lists, and making the case for EPCM's end-to-end delivery model.

At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption.

FDA approves AstraZeneca's Breztri as the first single-inhaler triple therapy for asthma in patients 12+, a new precedent for respiratory drug developers.

Leslie Weaver and George Hunt, IPS, discuss early sustainability and lean alignment in pharma construction that reduce costs, absorb disruptions, and keep projects on schedule.

At INTERPHEX 2026, Bryan Poltilove highlights a novel technology as a promising point-of-use media manufacturing approach with major sustainability and logistical benefits.

At INTERPHEX 2026, George Kwiecinski examines FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

Ryan Kelly, Rx360, explains how third-party audits and integrated quality-supply chain strategies protect pharma supply chains and patient safety.

At INTERPHEX 2026, David Chau and Stuart Tindal discuss automation, single-use durability challenges, and the shift to predictive control in continuous bioprocessing.

The industry is feeling the push to modernize facilities and manufacturing processes.

At INTERPHEX 2026, Bethany Silva, Jason Pennington, and Mel Radford discuss how smart sensors, connectivity, and advanced analytics are enabling predictive, insight-driven pharma manufacturing.

Avi Nandi, SK Pharmteco, explains at INTERPHEX 2026 how CDMOs simplify cell & gene therapy supply chains by managing lead times, consistency, and material expiry.

At INTERPHEX 2026, MasterControl CEO Dave Edwards details how AI tools are boosting efficiency and compliance in pharma quality and manufacturing without replacing human oversight.

Maria Batalha, Valgenesis, discusses how her team assited a comapny in centralizing drug substance data, standardize processes, and unlock powerful AI-driven insights.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.