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PODCAST

From Concept to Medicine - A Comprehensive Drug Development Journey

Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientist’s vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventure—filled with scientific breakthroughs, regulatory twists, and the relentless pursuit of innovation.In this podcast, we take you behind the scenes of pharmaceutical research and development, unraveling the complex and fascinating process that

science chemistry

All Episodes

10:08

158 - Special Feature Sections in Organic Process...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode explores the special feature sections in Organic Process Research & Development (OPR&D), highlighting current areas of high interest in process chemistry and pharmaceutical development. The purpose and function of these special sections is highlighted. The reasons the articles are pulled is that they gather research papers, reviews, and expert commentary, all focused on one timely area. This also makes getting up to speed much easier. One area of interest is the use of new

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10:17

157 - The Role of Quality by Design (QbD) in...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode focuses on the Quality by Design (QbD) approach and its implementation in the pharmaceutical industry to enhance product quality and process understanding. The core principles of QbD are detailed, emphasizing the importance of predefined objectives, deep understanding of the product and process, and control based on sound science and risk management. It also discusses how the use of Design of Experiments (DoE) is crucial for gaining this understanding and mapping out the relationships

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10:41

156 - Overcoming Scale-Up Challenges in...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

The episode dives into the common hurdles encountered during the scale-up of pharmaceutical processes. The starting point discusses the leap from laboratory to commercial production, emphasizing the fundamental shift in dealing with physical factors like mixing, heat transfer, and mass transfer. Key challenges is impurities and process robustness, the episode also explores practical concerns, such as raw material sourcing, equipment maintenance, and cleaning validation. The discussion touches upon

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9:41

155 - Applications of Flow Chemistry in Modern Drug...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode explores the increasing use of flow chemistry in the development and manufacturing of pharmaceutical products. The discussion begins by outlining what flow chemistry is, explaining how it involves performing chemical reactions inside a continuous stream, usually within narrow tubes or channels. The benefits of this approach are then explored. The core benefits of flow chemistry are safety, better control and scalable operationsThe episode then explores some concrete examples of flow

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12:16

154 - Regulatory Considerations for Starting...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode focuses on the crucial role of starting materials in drug substance (API) development and the regulatory considerations surrounding their selection. Starting materials are defined as specific substances that become significant structural parts of the final API molecule, and the episode emphasizes that their designation is not arbitrary but carries significant regulatory weight. The conversation explores how companies must justify their choice of starting materials, providing a solid

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13:20

153 - The Evolving Landscape of Continuous Processing...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode explores the shift towards continuous processing in the manufacturing of active pharmaceutical ingredients (APIs). The discussion outlines what continuous processing is, comparing it to traditional batch processing, and highlights the driving forces behind this evolution. The rise of enabling technologies like flow chemistry, quality by design (QbD), and the advantages they offer is discussed. The episode explores how flow chemistry and continuous processing enable the use of hazardous

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14:38

152 - Challenges and Strategies in Peptide Drug...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode delves into the often unseen complexities of manufacturing peptide therapeutics at a large scale. The initial focus is on the challenges involved in synthesizing these molecules, specifically the difficulties in ensuring every link is correct and maintaining high purity across large batches. The discussion explores solid-phase peptide synthesis (SPPS), the most common method, and the scale-up hurdles associated with it, including the quality of the solid support and the sheer volume of

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9:15

151 - Rapid Process Development and Scale-Up Using...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/24

This episode tackles a pivotal question in pharmaceutical development: How are parallel synthesis and automated reactor systems changing the game? The discussion centers on how these advanced tools, along with small-scale experiments, computer control, and statistical design, are driving efficiency and accelerating the delivery of therapies to patients. The episode explores how these approaches optimize the development process, improve scalability, and ultimately shorten the timeline for bringing

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21:23

21 - Principles of Good Documentation Practices (GDP)...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/18

This episode explores the essential principles of Good Documentation Practices (GDP) in manufacturing, emphasizing the necessity of clear, accurate, and traceable documentation. We discuss how detailed records, proper sign-off procedures, and systematic reviews are crucial for maintaining data integrity and supporting regulatory audits. The episode also highlights the significance of GDP in upholding quality, enabling effective investigations, and safeguarding against non-compliance within heavily

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20:04

32 - Data Management, Records, and Reporting in GLP...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode dives into the crucial aspects of data management, records, and reporting within a GLP environment. It details the GLP requirements for data acquisition, secure recordkeeping, and the final reporting of study findings. The episode stresses how a documentated evidence is needed to show compliance.The discussion highlights how systematic data management practices, including the use of validated software and electronic records, support data integrity and traceability. It emphasizes the

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19:57

31 - GLP Protocols and Standard Operating Procedures...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode examines the critical role of GLP protocols and Standard Operating Procedures (SOPs) in laboratory studies. It explores how detailed protocols are essential for ensuring the consistent execution of experiments and the reliable collection of data. The discussion explains the importance of developing a protocol.Key elements of protocol development are covered, including method validation, risk assessment, and periodic review. The episode explains how these measures actively support

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16:54

30 - Test Systems and Test and Reference Items in GLP...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode focuses on how to handle and manage test materials in a lab, following strict rules called Good Laboratory Practice (GLP). It explain the correct methods to use when managing and controlling test systems. These processes include the proper handling, storage, and tracking of test and reference items. The episode is all about keeping things accurate and consistent in experiments.The discussion explains how these strict controls protect the integrity of experimental results. It also

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14:14

29 – GLP Requirements for Facilities and Equipment...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode details the specific GLP standards that govern laboratory facilities and equipment. It covers essential aspects such as environmental controls, instrument calibration, and routine maintenance. The discussion explains how a meticulously controlled lab environment and properly qualified equipment are fundamental to producing valid and reliable test data. The focus in this episdoe is in facilities and equipment.The episode emphasizes the need for documented procedures and systematic

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10:32

28 – Key Elements of GLP Organization and Personnel...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode delves into the organizational requirements and personnel responsibilities that are fundamental to GLP. It explores how effective staff training, clearly defined job descriptions, and well-structured roles are vital for maintaining high-quality laboratory practices. The discussion highlights the interconnectedness of GLP and GMP. It specifically focus in how everyone involved is a study and how they have clearly defined responsabilities.The episode emphasizes that a well-organized team

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11:49

27 - Introduction to Good Laboratory Practices (GLP)...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode provides a comprehensive overview of Good Laboratory Practices (GLP). It defines GLP and explains their critical role in supporting cGMP compliance, focusing specifically on non-clinical testing environments. The discussion highlights how standardized lab procedures, meticulous method validations, and stringent environmental controls are essential for generating reliable test results. The hosts emphasize that those early studies tells if a drug is safe enought to test on

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17:15

26 – Electronic Records and Signatures Navigating 21...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode examines the regulatory requirements governing electronic records and electronic signatures as outlined in 21 CFR Part 11. We discuss the critical aspects of system validation, audit trails, and security measures that are essential for ensuring electronic documentation aligns with cGMP standards. We also explain how digital systems can be seamlessly integrated into existing GMP frameworks, enabling reliable, secure, and compliant recordkeeping while preserving data integrity throughout

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12:33

24 - Batch Records The History of a Batch (S16E4)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode explores the critical components of batch production records, demonstrating how they provide a comprehensive history of every manufacturing step from start to finish. We discuss the crucial role of accuracy, completeness, and real-time documentation in capturing product history, facilitating investigations, and ensuring regulatory compliance. The episode illustrates how deviations and corrective actions are documented and managed within batch records to facilitate continuous process

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21:00

25 - Laboratory Notebooks and Data Recording (S16E5)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode details best practices for maintaining laboratory notebooks and accurately capturing analytical data under Good Manufacturing Practice (GMP) requirements. We explain the significance of contemporaneous recording, proper correction methods, and secure storage in preserving data integrity. The episode discusses common challenges such as transcription errors and incomplete entries, outlining strategies to ensure that all laboratory records accurately reflect the testing processes and

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23:07

23 - Standard Operating Procedures (SOPs) Your GMP...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode examines the vital role of Standard Operating Procedures (SOPs) in standardizing operations and ensuring compliance with current Good Manufacturing Practice (cGMP) guidelines. We delve into the process of developing, reviewing, and updating SOPs, illustrating how they function as blueprints for consistent performance across all manufacturing stages. The episode emphasizes the critical need for clarity, periodic training, and rigorous adherence to SOPs, demonstrating how these practices

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21:02

22 – The ALCOA+ Principles Ensuring Data Integrity...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/17

This episode delves into the ALCOA+ framework (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, and Available) as the bedrock of data integrity within Good Manufacturing Practice (GMP). We explain how each principle guides the creation, maintenance, and review of records, ensuring the reliability and verifiability of every data point. Using real-world examples, we illustrate how implementing ALCOA+ protects critical information, facilitates regulatory

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270 results

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