Podcasts

The Co-chairs of the 2021 PDA/FDA Joint Regulatory Conference Program Planning Committee share their insights about this important conference, now in its 30th year. They will discuss the importance of hitting this significant milestone, what noted regulatory and industry speakers will be presenting, what’s new this year, what popular sessions are making a return, and what attendees can expect to gain from attending the event for compliance and regulatory updates.

Artificial Intelligence (AI) is changing how biotech and pharmaceutical companies operate. Increased competition and an enhanced regulatory landscape are forcing drug manufacturers to eliminate waste, create efficiencies and squeeze every last bit of productivity out of existing processes. The benefits can be enormous. A three percent increase in usable yield could increase revenue by millions of dollars. Pharma organizations that take advantage of AI/ML in GxP environments get better visibility into their manufacturing operations and can thereby optimize yields and predict anomalies thereby providing more to the market. We’ll explore where the industry is in its adoption of AI, what the challenges are in implementation that keep the pharma industry behind other industries, and explore case studies of those intrepid organizations who have worked through the challenges to implement and reap the benefits.

Efficiency, speed-to-market, and access to unique expertise are among the key benefits of partnering with a contract development and manufacturing organization (CDMO) offering integrated, end-to-end services. Applying a fully integrated approach to drug discovery, development, manufacturing, packaging, and more, all with a single project manager as the primary point of contact and a single plan across multiple scientific disciplines, provides pharmaceutical and biotech innovators with tangible benefits. PPS has a superior record of delivering successful product launches with the seamless transfer of technology, documentation, and materials across global sites. Regulatory know-how and deep experience across a spectrum of projects and categories further solidify the company’s standing as an elite integrated CDMO.

GMP firms have a constant struggle with the task of reducing fibers, particulates, and microorganisms within classified areas. A main source of this problem is paper products used to document operations. Veltek Associates, Inc. has developed an innovative way to address and solve problems surrounding particulate and fiber shedding from cleanroom documentation with our CleanPrint 10® synthetic writing substrate, Core2Write® customized documentation, and Core2Print® HEPA filtered cleanroom printing system.

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Sue Marchant, director of product at MasterControl, will discuss how AI technology is helping pharmaceutical companies address CAPA and root cause investigations. The CAPA process has historically been more corrective than preventive, hard to track and implemented without context. During the podcast, we will be discussing the options available today to connect quality data and subsequently what problems can be solved using AI. These technologies will turn the tables making CAPA more preventive than corrective with the ability to track process in real time and understand the contributing factors and considerations surrounding an event. Additionally, Marchant will explain how AI combines and analyzes data, pinpoints relationships, and provides valuable process improvement. Companies should not be intimidated or hesitant about implementing AI technology. Today’s technology has AI capabilities embedded in the software to accelerate AI development. Companies no longer need specialists to get started and take advantage of the benefits.

The bioavailability of insoluble compounds remains one of the biggest challenges to drug delivery. While there are strategies that can be applied at lower dosage levels, it is particularly difficult to formulate for improved bioavailability at high dosage levels. Improving bioavailability can be crucial to creating a dosage form that is easy to use and meets requirements for patient compliance. CoreRx tackles bioavailability challenges for molecules by leveraging our membrane flux in vitro technology. Today, we will discuss how using this technology enabled CoreRx to discern which factors were most important for bioavailability of a model Class IV compound, and led to development of a formulation with ~70% increase in bioavailability.

Eurofins BioPharma Product Testing highlights how it overcomes the challenges faced in sterile fill finish manufacturing in the bio/pharmaceutical industry at our San Diego, CA facility. With state-of-the-art facilities and a vial filler, Eurofins provides a solution for small batches of sterile GMP or GLP products for use in Toxicology Studies, as well as Phase I or Phase II clinical trials by eliminating human error and other associated risks.

Understand challenges posed by updated E&L guidance for medical devices (ISO 10990-18) Insight into considerations for analytical setup that impact regulatory compliance Overview of materials E&L risk profiles and testing requirements

In nearly all industries, there has been a general shift away from on-site construction to prefabricated solutions. Specifically, the requirement in the biopharmaceutical industry to address speed to market and lower the total cost of ownership for facilities has accelerated this movement. More recently, the impact of COVID on our society has placed a strain on how we operate while also creating an immense need for additional capacity.

Core2Scan® is a complete RFID tracking solution designed for the pharmaceutical and biotech industry. Core2Scan® can track assets, people, raw material, and inventory. The asset tracking piece incorporates asset management tools for monitoring equipment calibration, PM, and service requests. This solution can also be used for process improvement, allowing you to track asset and personnel flow throughout your facility. Compliance support is built into Core2Scan®. The system provides a history of all asset movement, giving users a thorough and documented audit trail. Core2Scan® includes hardware, software, and RFID tags that can all be used in and out of the cleanroom. With software that supports 21 CFR Part 11 compliance, you will have a tool that meets your needs.

Quality is one of the most important components of products in pharmaceuticals. Traditionally, the onus was on the manufacturing function to deliver quality. But what if every single member of the organization was completely focused on customer needs? Big Q, or Quality culture, ensures that quality is up to everyone. DuPont expert will discuss more about how its excipient platform is taking customer cues to implement this total quality focus.

Pharmaceutical Technology interviewed Cloudleaf about trends in tracking vaccines through the supply chain.

- Examine the role of secondary packaging in sustainability and safety. - Healthcare companies seek standards for low migration, low odor and low VOCs. - Colbert’s Clean Carton provides a proven formula.

Meeting Co-Chair Susan Schniepp provides insight into this year's regulatory conference.

BIO President and CEO discusses innovation and policies for the bio/pharmaceutical industry.