Author Archive

Delivering Complex Parenteral Formulations

Patricia Van Arnum PharmTech editorProgress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges. Unique formulation strategies and solutions are being investigated to extend the release of target peptides, proteins, nucleic acids, and small molecules for systemic, local, or cellular delivery. Pharmaceutical Technology will hold a live educational webcast, “Complex Parenteral Formulations for the Delivery of Peptides, Proteins, Nucleic Acids and Small Molecules,” on Thursday Nov. 21 from 10:00 to 11:00 AM EST, to examine the delivery science and product development of complex parenteral formulations. Read more »

Regulatory and QA/QC Focus: Elemental Impurity Analysis

Patricia Van Arnum PharmTech editorAs the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS). Understanding the necessary technical controls to implement and manage analytical operations is crucial to ensure regulatory compliance. Pharmaceutical Technology will present a live educational webcast, “Achieving Regulatory Compliance When Moving to ICP-MS for Elemental Impurity Analysis,” on Wednesday, November 6, 11:00 AM to 12:00 PM EST to provide insight from leading industry experts on ICH, USP, and EMA guidelines for elemental impurity analysis and best practices and strategies to optimize the analytical workflow, data management, and data reporting when using ICP-MS. Read more »

Preparing for Regulatory Inspections

Patricia Van Arnum PharmTech editorRegulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Pharmaceutical Technology will present an educational webcast on Thursday Nov. 7th from 1:00 to 2:00 PM EST, “Ensuring Preparedness for Regulatory Inspections,” which will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency for providing access to that information. Read more »

Meeting Technical and Regulatory Requirements for Organic Impurity Control and Analysis

Patricia Van Arnum PharmTech editorProduct quality is of paramount importance to pharmaceutical manufacturers, and implementing a strategy for impurity control is crucial. Organic impurities cover a wide spectrum of compounds that have varying structures, behaviors, and characteristics. Organic impurities can result from the manufacturing process, storage conditions, or degradation resulting from light, heat, and other external factors. Deciding what technology or analytical methods to use to detect and measure organic impurities is a challenge. Pharmaceutical Technology will hold a live educational webcast, “Meeting Regulatory and Technical Requirements for Organic Impurity Analysis, on Tuesday Sept. 24 at 11:00 AM EDT to 12:00 PM EDT to provide insight on the regulatory, compendial, and ICH requirements for organic impurity control and analysis as well as best practices in analytical method development, method selection, and method validation for detecting and quantifying organic impurities in drug substances and drug products.

The panelists for the webcast will be: Timothy Watson, PhD, and research fellow in the GCMC Advisory Office at Pfizer and a member of the PhRMA Expert Working Group on the ICH Q11 regulatory guidance document for drug substances; Mark Argentine, PhD, senior research advisor, analytical sciences R&D with Eli Lilly; and Hildegard Bruemmer, PhD, operational laboratory manager, SGS Life Science Services, Berlin. The panelists will provide insight on the regulatory and compendial requirements for organic impurity control and analysis in drug substances and drug products. They will also share insight on selecting the appropriate analytical methods for the detection, analysis, and quantification of organic impurities and offer related case studies on how best to ensure product quality.

Audience members may ask questions of the panelists during the live webcast. Information on how to register for the webcast, “Meeting Regulatory and Technical Requirements for Organic Impurity Analysis” for Tuesday Sept. 24 at 11:00 AM EDT to 12:00 PM EDT and for on-demand viewing is available here.

Risk-Mitigation Strategies in Drug Manufacturing for Emerging Markets

Patricia Van Arnum PharmTech editorRisk and reward. It is a balance that has to be achieved in any business endeavor and is of utmost importance for pharmaceutical and biopharmaceutical companies managing their growth and manufacturing in emerging markets. Emerging markets are a crucial part of pharmaceutical companies’ growth strategies, but in serving those markets, pharmaceutical and biopharmaceutical manufacturers must align that strategy with partners that can facilitate access to local markets, manage complex supply chains, meet global and national regulatory standards for quality, and secure production for local as well as established markets in North America and Western Europe. Read more »

Quality Focus: Ensuring Raw Material Transparency

Patricia Van Arnum PharmTech editor Quality is of utmost importance in drug development and manufacturing. The increased globalization of the pharmaceutical and biopharmaceutical industries, resulting in more complex and elongated supply chains on a raw material and ingredients basis, obligates suppliers and pharmaceutical and biopharmaceutical companies to develop ways to achieve greater transparency and understanding of those supply chains to ensure product quality and regulatory compliance.  Read more »

Key Ways for Ensuring Global Regulatory Compliance

Patricia Van Arnum PharmTech editor International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance. Optimizing a quality management system to ensure regulatory and corporate compliance for product registrations for new and existing drugs in new geographic markets is essential for commercial success. Pharmaceutical Technology will examine the operational, organizational, and technological-based requirements on how to reduce risk and achieve operational efficiency for global product registrations in a live webcast on Tuesday June 11 from 2:00 to 3:00 PM EST. Read more »

FDA Offers Insight on QbD for Modified-Release Products

Patricia Van Arnum PharmTech editor FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality. Understanding the critical quality attributes of the ingredients in a formulation, including excipients, and the critical process parameters in the manufacturing process of the finished drug product is crucial for successfully implementing QbD. Pharmaceutical Technology will be holding a live webcast on Thursday May 23 from 10:00 AM  to 11:00 AM EST to examine the regulatory and technical considerations in implementing QbD for coatings in modified-release formulations, including strategies to mitigate the risks associated with alcohol-induced dose-dumping and the application of alcohol-resistant coatings. Read more »

Overcoming the Challenges in Biopharmaceutical Stability Testing

Patricia Van Arnum PharmTech editorAs pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing. Unlike traditional small-molecule drugs, stability studies for biopharmaceuticals can be one of the most critical and challenging aspects of large-molecule drug development. The size and complexity of most proteins provide fertile ground for intramolecular changes and multiple routes of degradation, and to assess their effects, each must be correlated to the bioactivity of the drug. Pharmaceutical Technology will examine biopharmaceutical stability studies in more depth by gaining input from leading industry experts, in a live webcast, “New Strategies for Biopharmaceutical Stability Testing,” on Thursday May 9th from 2:00 to 3:00 PM EST. Read more »

PharmTech Webcast: QbD in Solid Dosage

Patricia Van Arnum PharmTech editor Quality by Design (QbD) is changing drug development and manufacturing. The science- and risk-based approach inherent in a QbD paradigm increases process understanding and leads to better drug development and manufacturing. Sharing lessons learned and strategies for applying QbD in solid dosage development and manufacturing is valuable. Pharmaceutical Technology will address this topic in a webcast,A Pragmatic Application of QbD: Turning Theory into Tangible Success” this Thursday May 2 from 11:00 to 12:00 PM EST.

Two industry experts will share their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects. Through several case studies, these experts will provide lessons learned and advice on the measures they took that enabled the success of their projects; steps that can be universally applied to other projects.

Don Barbieri, associate director of formulation and process development at Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical process parameters) as well as how to perform risk assessment, incorporate risk mitigation into a process, and how to develop a design of experiments (DoE).

David Smith, pharmaceutical specialist, formulation and process development at Patheon, will present a case study where the pragmatic application of QbD enabled a successful technology transfer of a film-coated tablet from Phase III to commercial scale.

Further information, including how to register for the complimentary webcast, may be found  here.

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