Authors

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.

The Push for Momentum, Not Mistakes in Orphan Drug Development

This article outlines common CMC problems that are obstacles that steal momentum and create costly detours in the development or orphan drugs.

Focusing on the Fundamentals of Formulation

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

Nasal Delivery of Spray Dried Biologics: Opportunities & Challenges

Automate Aseptic Filling: Closing the System at Full Modularity

Shifting to automated, closed modular manufacturing systems is growing increasingly crucial for biopharmaceutical production.

Why PROCIPIENT® Sets the Standard for the Critical Role of High Purity Solvents in Complex Drug Delivery Systems!

In this interview, Rishi Pimentel of gChem explains how PROCIPIENT®, a cGMP-compliant excipient-grade DMSO, supports advanced therapies with superior purity and sterility, mitigates risks of using industrial-grade solvents, and strengthens regulatory readiness and supply chain security.

What’s Reasonable to Expect from Agentic AI in Pharma? Part Three: Tapping Agentic AI’s Potential

In the conclusion of this three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

Adding SYLOID® Mesoporous Silica to Improve Run Time and Yield for Micronization Processes

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.

Manufacturer Guidelines for the Secure Destruction of Controlled Substance Pharmaceuticals

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Executive Summary: Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Inhaled Product Design and Development

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.

Molecular Properties of PROTACs and the Relationship to Formulation Design

Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.

Entering New Domains for 3D Printing of Drug Products

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

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.

Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery Formulations

The growing demand for liquid medicines is increasingly driven by the unique needs of several distinct patient groups, improving compliance in these demographics through flexible, palatable dosing options.

DMSO as Skin Penetration Enhancer

Continued Process Verification Is Critical in Pharmaceutical Manufacturing

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

The Role of Flavoring Agents and Taste Modulation Strategies in Drug Development

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.

Strategies for Overcoming Common Challenges in Tech Transfer

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

Breaking barriers: EnzeneX™ to EnzeneX™ 2.0

Shilpa Gadgil, PhD (VP, Head of Process and Analytical Development, Head of CDMO Development) discusses Enzene's new technologies and the New Jersey site capabilities.

Mechanistic Modeling of Renal Clearance: Optimizing Dosing Strategies for Elderly Patients

This paper provides an in-depth overview of the anatomical structure and functional dynamics of renal filtration, secretion, and reabsorption processes that govern drug clearance.

Entering New Domains for 3D Printing of Drug Products

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Picodroplets for Biologics Discovery and Scale-up: A Novel Automation Approach

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

Photometer Calibration: Calibration Error Due to Errors in Gravimetric Standard of Measurement

This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics

Rapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.

Executive Summary: Commercial Tech Transfers in OSD Manufacturing

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.