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Excipient Selection Strategies to Mitigate Nitrosamine Risks

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Navigating Biopharma Complexity: Why Long-Term Partnerships Matter

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

Batch Certification for New Manufacturing Technologies: The Qualified Person Role in a Digital Environment

As advanced manufacturing technologies reshape pharmaceutical production, the Qualified Person (QPs) must evolve from a traditional document reviewer into a digitally fluent leader capable of navigating complex data ecosystems, real-time analytics, and automated control systems. This article presents a holistic framework for “Certification by Design,” highlighting how QPs can ensure compliant, agile, and science-based batch release in the era of Industry 4.0.

In-line UV Spectrometry Monitoring in Cleaning Validation

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

Strengthening Sustainability Through Smarter Ingredients: Designing Resource‑Efficient Formulations

Excipients contribute to more sustainable practices throughout the life cycle of a drug.

ROSS Ribbon Blenders - Video in Action

ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.

How to Support Emerging Biopharma Programs Through Rapid Candidate Identification

Success in emerging biopharma depends not only on speed, but also on making confident, data-informed decisions early in development while managing increasing molecular complexity.

In-line UV Spectrometry Monitoring in Cleaning Validation

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

Eli Lilly Introduces Multi-Dose Zepbound KwikPen to Expand Obesity Treatment Options

The multi-dose pen, designed to deliver a full month’s supply, could help alleviate device supply limitations and influence future distribution strategies.

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

Viral Safety 2.0: Plant-Ready Actions for ICH Q5A(R2) Compliance

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

Bladder Cancer: FDA Expands Anktiva Without a New Trial

The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.

Improving AAV Vector Quality with In-Process Monitoring of Capsid Formation

CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

The Roadmap to Asset Performance Management in Life Science

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

Reducing Risk in Small Molecule Development: Choosing the Right CDMO Partner

Terry Novak, CEO of Benuvia, explores how pharmaceutical and biotech companies can mitigate development risks and accelerate speed-to-market by prioritizing technical alignment, robust project management, and early-stage collaboration with the right CDMO partner.

Application of Predictive Modeling in the Development of Amorphous Solid Dispersions

Effective modeling and simulation can reduce physical experimental requirements, ASD development risks, and time to market.

Using Automation to Enhance Manufacturing: Building the Foundation for Pharma 4.0

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

HME vs Spray Drying: A Comparison of Saturated Solubility Enhancement

Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.

Leveraging 3DP In-Blister Tech for Real Time Release

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet 3D-printing enables advanced process analytics, tablet-level traceability, and continuous monitoring to provide a data-driven approach to pharmaceutical production. By measuring critical quality attributes for every tablet throughout manufacturing, the platform enables continuous process verification, targeted identification of deviations, and reduced waste compared with traditional batch-based quality methods. This integrated foundation supports real-time release while delivering greater transparency, process control, and operational efficiency across the product lifecycle.

Excipient Selection Strategies to Mitigate Nitrosamine Risks

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

CPHI Milan 2026: Digital Supply Chains

Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.

ICH Q6B for Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

Optimizing Testing in Cell and Gene Therapy: A Key Driver for Industry Growth and Adoption

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Using Automation to Enhance Pharmaceutical Manufacturing

The future factory will be defined by how well automation tools work together with people, processes, and quality systems to make pharmaceutical manufacturing faster, smarter, more transparent, and more reliable.