Exceeding Your Benchmark

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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.

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

Pharmaceutical manufacturers are under increasing pressure to deliver sterile, high-quality medicines in smaller batches and faster cycles. As pharma manufacturing evolves evolves, regulatory demands have intensified especially following the 2023 revision of EU GMP Annex I, which places new emphasis on contamination control strategies, improved traceability, and minimizing human intervention throughout production. According to American Pharmaceutical Review,the updated guidelines specifically call for technologies that reduce human involvement and support robust contamination control. This requires manufacturers to rethink how precision machining and mechanical component design support advanced containment. So how can manufacturers ensure safe, efficient, and scalable filling operations, especially when the stakes are patient lives? On this episode of Exceeding Your Benchmark by Benchmark Products, host Michelle Dawn Mooney sits down with Corinna Politi , Head of Export Sales at MPA Technical Devices. They explore how MPA’s precision machining and customizable dosing components are enabling safer, more efficient sterile drug manufacturing in line with evolving global regulations.

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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. The conversation begins with a distinction between traditional drug manufacturing and sterile compounding, highlighting the role of USP 797 guidelines in ensuring drug safety. Abby explains how compounding fills critical gaps in patient care when commercially available medications are not suitable. She also breaks down the three categories of compounded sterile preparations (CSPs) and the importance of beyond-use dates in maintaining drug efficacy. The discussion then shifts to contamination control, emphasizing the role of primary and secondary engineering controls, proper garbing, and hand hygiene in maintaining sterile environments. Abby stresses the importance of environmental monitoring, explaining how facilities track factors like air quality, particle counts, and microbial contamination to ensure safety. Additionally, Abby introduces her travel companion, “Petrie the Penicillium,” a plush microbe, and shares insights into best practices for cleaning and disinfecting sterile compounding areas. She concludes by emphasizing the essential role of compounding in patient care, even with advancements in drug manufacturing. The episode offers valuable insights for professionals in pharmaceutical compounding, microbiology, and regulatory compliance.

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Exploring the Fundamentals of Validation in Life Science Manufacturing

In the rapidly evolving domain of life science manufacturing, validation emerges as a cornerstone to ensure that products meet stipulated requirements concerning quality, safety, and efficacy. This pivotal aspect of manufacturing comes to focus as regulatory landscapes shift, mandating stringent compliance to ensure patient safety. In a recent episode of Exceeding Your Benchmark, a podcast by Benchmark Products, host Gabrielle Bejarano sits down with Nessiem Samuel, Co-Founder and Head of Compliance and Validation at GxP Impact Consulting, to explore the essence and intricacies of validation in life science manufacturing. The discussion spans from delineating the validation process and its criticality in ensuring product safety to the challenges faced by startups and established operations in adhering to validation norms amidst evolving regulations. The episode underscores validation as a multi-faceted process entailing verification to ensure that products align with design specifications, guaranteeing safety and efficacy once they reach the patients. Samuel elaborates on the lifecycle approach to validation, emphasizing the importance of commissioning, qualification, and eventual validation in facility and process aspects. He shares insights on the significance of in-house process validation while suggesting the outsourcing of early commissioning tasks. Samuel also touches on strategies for effectively managing growth in life science manufacturing while ensuring validation and compliance, highlighting the role of robust planning and asset management in this endeavor. For those looking to deepen their understanding of validation's pivotal role in life science manufacturing, this episode is a valuable resource. It offers expert insights into navigating the compliance and validation landscape effectively.

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Redefining Contamination Control Practices in Pharmaceutical Manufacturing

Fred Ayers at pharmaceutical manufacturer Eli Lilly discusses the trends in contamination control and regulations surrounding this.

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Connecting Data to Improve Your Contamination Control Strategies

Contamination control is absolutely critical in the pharmaceutical industry and includes particulate, microbial, product carryover, chemical, and viral aspects of contamination and often involves proactive, reactive, and supporting aspects. However, regulations, liabilities, and patient health added to the mix create data silos that often form multiple processes and make it difficult to create efficient and effective contamination control strategies (CCS). How can we connect these data silos to create more effective and efficient CCS protocol in the pharma world? On today’s episode of Exceeding Your Benchmark by Benchmark Solutions, host Gabrielle Bejarano speaks with Sheba Zaman, Head of Product Specialists and Training Services at Novatek International, to talk about how pharmaceutical companies can integrate data use in their processes to improve their contamination control strategies, while abiding by compliance standards and protecting their own data security. Bejarano and Zaman also discussed… Challenges in the pharmaceutical industry with managing compliance data How technology can provide visibility in a holistic manner, and the benefits technology can bring in decision-making and trend analysis The predicted evolution of compliance software in the next five to ten years Zaman explained how companies can quell their concerns about cybersecurity: “Cybersecurity is a big concern; data integrity is a big concern. So, companies just do have to make the big investment to mitigate the risks of, for example, cyber security. They need to do a data integrity risk assessment. So, for any solution that they are implementing to go through the data integrity guidance requirements and basically go through the solution and ensure that both your process and your solutions are meeting the data integrity requirements. Go through that validation process.” Sheba Zaman is an experienced Computer Systems Analyst who has worked with Life Sciences information technology. She is Head of Product Specialists and Training Services at Novatek International and was previously Director of Sales, Senior Product Specialist, and Manager of Technical Sales. Zaman also attended Concordia University, where she earned a BS in Computer Science at Marianopolis College, where she earned a DEC in Health Sciences.

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

Pharmaceutical companies invest significant resources in research and development to discover new drugs and therapies and improve existing ones. This involves rigorous testing, clinical trials, and obtaining regulatory approval before a drug can be sold. Government agencies, such as the Food and Drug Administration (FDA) in the United States, oversee the approval process and conduct regular inspections of manufacturing facilities to ensure compliance with regulations. But what are some of the most significant challenges facing the pharmaceutical industry today, and how are companies addressing them? On today's episode of the Exceeding Your Benchmark, host Michelle Dawn Mooney speaks with Jim Fries, the Chief Executive Officer of Rx-360, to discuss some of the key benefits of using supplier evaluations and how they can help pharmaceutical companies to ensure supply chain integrity and compliance with regulations. Jim Fries’ core piece of advice: prioritize compliance and quality in all aspects of the pharmaceutical manufacturing process. This includes investing in robust quality systems, conducting regular audits, and seeking licensable audit reports from independent third-party auditors. By doing so, manufacturers can ensure that their products are safe and effective and meet regulatory requirements. "We have the ability as a non-profit to license a report out to other pharmaceutical organizations in the industry that may be using that same supplier and try to double-check authenticity," said Fries. Michelle and Jim also discuss… 1. What are the benefits and steps in obtaining a licensable audit report for pharmaceutical manufacturers, and how does it aid in regulatory compliance and product quality assurance? 2. In what ways does Rx-360's collaboration with Benchmark Products enhance supply chain security and quality within the pharmaceutical industry? 3. How can pharmaceutical manufacturers leverage licensable audit reports to gain a competitive advantage in the industry and improve patient outcomes? "It's a wonderful way for pharmaceutical organizations to license with their supplier to ensure that safety and quality information on that particular facility is distributed amongst the pharmaceutical community where we are also actively collaborating," said Fries. James M. Fries, CEO at Rx-360, has worked with teams at OrthoForge, VNUS Medical, Vascular Insights, etc. He received his B.A. in Organizational Behavior and his MBA from Eastern University in St. David’s, PA.

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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.

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How Cell and Gene Manufacturers Can Scale to Meet Demand

Between 2022 and 2030, the cell and gene therapy sector is expected to experience a compound annual growth rate (CAGR) of 39.42 percent, BioSpace said of a recent Vision Research Report. This is quite a large anticipated growth; how will startups and current manufacturing companies work to meet this growing demand? On today’s episode of Exceeding Your Benchmark, Guest Sumit Verma, Senior Vice President, Global Strategic Manufacturing at Iovance Biotherapeutics addresses cell and gene therapy industry trends and challenges and what manufacturers can do to promote growth in the sector. Verma also discussed… 1. The greatest challenges biopharma startups face 2. How established CGT manufacturers are preparing to meet an increased demand 3. What place automation has in advanced cell manufacturing Verma believes there are three key areas manufacturers need to target to help supply meet increasing demand. “I think most players are focusing on three big things: one is around scalability, the second is around supply chain, making sure we have all the components, and last is about talent. Verma said of the talent piece, “There aren’t many people who have advanced programs for therapeutic manufacturing today…there are a lot of synergies and the big pharma have done a great job establishing developing programs that are very supportive of their large plants and their scalable efforts and we’ve seen the need to do that in cell and gene therapy.”

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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. Of the standout changes, White noted that Annex 1 makes a big distinction between what cleaning is versus what disinfection is, citing that the regulations detail specific differences, and specify that disinfection can only occur after cleaning is complete. Annex 1 emphasizes that there is an “acknowledging that surfaces can only be adequately disinfected once they’re clean —so you have the separation of cleaning versus disinfection,” said White. He also added that there is a significant emphasis on “material transfer”, which according to White, is “monitoring the materials throughout your facility, and as they are transferred into your more critical areas, how to mitigate the impact of the risk of contamination during that process.” Evidently, the updated Annex 1 regulations are placing a focus on higher scrutiny in the quality production of sterile manufacturing healthcare products. A solution to avoiding contamination is the Benchmark Products Suite° line —a series of Ultra-Fiber material products-to help eliminate residue. Leftover residue is quite common in sterile manufacturing companies, and White said that the sources are normally the same culprits, which are disinfectants themselves, sporicidal agents, and even lubricants from equipment.Residues that are not removed can potentially harbor dormant bio burden and impact the effectiveness of disinfectants subsequently applied. In terms of validating newly established SOPs that comply with Annex 1, Chris suggests choosing a time of facility shut down in an uncleaned area and conducting baseline environmental monitoring sampling. Following a cleaning according to the new SOP, sampling in the same locations is repeated to show an overall reduction in the level of bioburden. He mentioned that the Benchmark Products Suite line offers “Ultra Fiber technology, which allows you to remove residues to make better surface contact with the surfaces that you’re trying to disinfect, and it also contains the contamination without transferring it from one surface to another.” Companies that prioritize the cleaning steps and create a dedicated schedule for it will be on track to meet the compliance goals.

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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.

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Exceeding Your Benchmark