Exceeding Your Benchmark

About Exceeding Your Benchmark

Welcome to Exceeding Your Benchmark, a podcast by Benchmark Products. Tune in as we explore the life science industry's relevant topics, discuss industry-leading practices, and dive into cutting-edge solutions the industry has to offer. This is the Exceeding Your Benchmark Podcast.

Publisher

MarketScale

Category

business

Language

en

Explicit

Yes

First episode

3 Nov 2022

Latest episode

21 Aug 2025

Latest episodes

10 episodes in the feed.

1. 

   21 Aug 2025

   Pharma Manufacturing: Meeting Annex I with Precision Machining for Safer Sterile Drug Production

   Corinna Politi of MPA Technical Devices explains how precision machining and custom dosing components are helping pharmaceutical manufacturers meet Annex I requirements in sterile drug and pharma manufacturing.

2. 

   11 Mar 2025

   Sterile Compounding and Contamination Control with Abby Roth

   In this episode of Exceeding Your Benchmark, host Michelle Dawn Mooney speaks with Abby Roth, founder of Pure Microbiology, about sterile compounding and contamination control. Abby shares her expertise in microbiology, sterile environments, and best practices in pharmaceutical compounding.

3. 

   17 Nov 2023

   One Year of the Exceeding Your Benchmark Podcast

   In celebration of its first year, the Exceeding Your Benchmark Podcast from Benchmark Products, looks back at interviews with experts from life science and pharmaceutical manufacturing on timely topics from Annex 1 to contamination control.

4. 

   26 Oct 2023

   Exploring the Fundamentals of Validation in Life Science Manufacturing

   Nessiem Samuel, Co-founder and Head of Compliance and Validation for GxP Consulting, explains the fundamentals of validation in life science manufacturing.

5. 

   20 Jul 2023

   Redefining Contamination Control Practices in Pharmaceutical Manufacturing

   Fred Ayers at Eli Lilly gives an overview of contamination control practices in pharmaceutical manufacturing.

6. 

   10 May 2023

   Connecting Data to Improve Your Contamination Control Strategies

   Sheba Zaman, Head of Product Specialists and Training Services at Novatek, explains why pharmaceutical companies should embrace tech use for their data to improve their contamination control methods, and what they can do mitigate any cybersecurity concerns they may have.

7. 

   23 Mar 2023

   Revolutionizing the Audit Process: Advancements in Supplier Assessments Within the Pharmaceutical Sector

   Leveraging Licensable Audit Reports for Enhanced Compliance, Operations, and Patient Outcomes in the Pharmaceutical Industry

8. 

   10 Feb 2023

   How Life Science Manufacturing Facilities Can Successfully Adapt To Change

   In this podcast episode of "Exceeding Your Benchmark," host Gabrielle is joined by Ashley Harp, Lead Process Engineer at CRB. They discuss the challenges life science companies are facing as they adapt to new technologies and advancements in manufacturing, specifically in the area of combining highly potent active pharmaceutical ingredients (HPAPIs) and monoclonal antibodies into antibody drug conjugates (ADCs). Ashley explains that these changes in drug delivery allow for targeted therapies, and that ADCs are a combination of HPAPIs and monoclonal antibodies, chemically bound together via a linker. The goal of ADCs is to increase the therapeutic window by delivering a drug directly to a target cell and minimizing off-target effects and systemic responses. Ashley notes that even though these therapies have been around for a long time, recent improvements in synthesis, linker technologies, and regulatory approvals are driving rapid growth and change in the industry. One of the main challenges Ashley highlights is the need for a balance between containment and cleaning, and aseptic facility design in ADC manufacturing. In the past, equipment and facilities were designed for either aseptic manufacturing or for product and personal protection, but now the standard and expectations are for both. “We've completed risk assessments, changed design of equipment, improved facility design all to allow for high standards for both personal protection as well as product protection." Advances in cleaning practices and materials have also led to new test methods to check for the presence or absence of contaminants in new products. Another challenge is a lack of adequate manufacturing capacity, especially due to the focus on COVID-related products. Ashley emphasizes the need for facilities to be designed for the right products and “not just high-speed, high-throughput production”. Gabrielle and Ashley continue to discuss the challenges companies face in transitioning from clinical to commercial life science manufacturing. Ashley highlights the need for expertise in small-scale production, safety, and efficient scaling as clinical trials progress. They also discuss the importance of rapid changeover between different drug products in clinical facilities and the need for improved delivery systems as they move into late-phase clinical and commercial manufacturing. As companies move to larger scales, the processes need to be more efficient, with methods for personnel and material movement, ensuring that the space remains clean, and understanding the increased use of cleaning materials and sanitizing agents. The focus on contamination control strategies is also emphasized, with an increased expectation that manufacturers prove that they have strategies for microbial and cross-contamination. The host and Ashley also discuss the importance of sustainability and waste handling as companies move into commercial manufacturing, and the need for companies to decide whether to build or adapt their own in-house manufacturing facilities or partner with a contract manufacturing organization (CMO). Ashley advises that companies should consider experience and scheduling, along with the robustness of their internal quality systems, when making this decision. Overall, the podcast highlights the ongoing challenges in the industry as companies adapt to new technologies and advancements in manufacturing, specifically in the area of ADCs.

9. 

   21 Dec 2022

   How Cell and Gene Manufacturers Can Scale to Meet Demand

   Sumit Verma of Iovance Biotherapeutics provides insight on current and future cell and gene therapy sector growth and how the industry plans to tackle the skyrocketing demand.

10. 

    3 Nov 2022

    What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023 with Chris White

    Over the summer new GMP Annex 1 regulations were released by the FDA and EMA, prompting new changes to become standard protocolin sterile manufacturing companies. By August 2023, the regulations will take effect and companies will have to ensure that they are in compliance with the guidelines set. Discussing this on a new podcast, host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different, and how manufacturing companies and facilities can meet the regulations of Annex 1.

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

1 ratings

Contact Exceeding Your Benchmark

Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.