Podcasts

In this episode of the Drug Solutions Podcast, John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals shares outsourcing strategies in biopharma.

In this episode, Fernando Muzzio provides greater insight into a novel approach to improving drug solubility—continuous melt coating.

In this episode, Grant Playter, assistant editor, sits down with Rosalind Beasley, vice president, Digital Innovation, Dot Compliance, to discuss the current state of the compliance and validation industry.

In this episode, experts share their insights into important drug packaging advances of the past, present, and future.

Samsung Biologics is responding to industry challenges with various development projects and services that improve overall timelines and efficiencies when manufacturing new medicines.

In this episode of the Drug Solutions Podcast, Feliza Mirasol, science editor, discusses the changing parameters for oral solid dosage forms as driven by APIs and new chemical entities with Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, discusses the importance of proper training for aseptic processing with Patrick Nieuwenhuizen, director senior consultant, PharmaLex.

Crystallization inhibitors maintain super saturation of free drug during the absorption window upon oral administration. Formulators can achieve this by utilizing function excipients which provide solubilization enhancement and crystallization inhibition. We recently used the inhibitors to limit precipitation of drugs during the lipolysis of SEDDS and correlated with the Vivo performance. Additionally, these functional inhibitors effectively increased drug load and improved overall bioavailability by forming supersaturated-SEDDS. This podcast will cover the role of crystallization inhibitors in formulation and how to use in SEDDS formulation effetely.

For companies looking to bring mRNA therapeutics and vaccines to market, TriLink’s proprietary GMP-grade CleanCap® reagents offer an immediate solution for swiftly scaling from clinical to commercial. CleanCap technology is the fastest and easiest way to produce a 5’ Cap1 mRNA with 95% efficiency. GMP CleanCap reagents are a modern alternative to enzymatic capping and are ready to accelerate your mRNA therapeutic development. In this podcast, we will discuss how TriLink discovered this mRNA capping method and how they made it scalable to support global vaccine supply, as a key raw material for over 3 billion vaccines doses against COVID-19.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.

Biopharma 4.0 is fundamentally changing the way that manufacturers do business. It will enable better products produced faster, with consistent high quality at a reduced cost. The process of moving from silos of automated or semi-automated processes (Biopharma 3.0) to a fully connected enterprise comprised of smart things is a journey that many manufacturers are only just beginning. Tune in to learn more on the latest status and impact that Biopharma 4.0 has on biopharmaceutical manufacturing.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.

In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

In this episode of the Drug Solutions podcast, Felicity Thomas, European Editor, talks to a panel of experts on drug dosage forms trends that have been impactful in recent years and those that may have an impact in the future.

This is the year in which manufacturers will have the courage to bet on data aggregation and AI solutions that help them grow their capacity, moving away from pilot mode and embedding those tools as foundational assets. These have become critical levers to support the expanded demand for drug manufacturing, especially exacerbated with the pandemic. Join John Vitalie, CEO at Aizon, as we discuss how Pharma 4.0 is transforming the pharma landscape to bring gains to manufacturers and to the patients they serve.

In this episode of the Drug Solutions Podcast, Chris Spivey, Editorial Director talks about the economic and geopolitical benefits of controlling pharmaceutical manufacturing through reshoring, with Dr. Fernando Muzzio, distinguished professor of chemical and biochemical engineering, Rutgers University and Frederic Kahn, VP Sales, Wavelength Pharmaceuticals

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview Sean Tucker, PhD, chief scientific officer of Vaxart, on developing oral recombinant vaccines.

One of the challenges facing gene therapy manufacturing is the lack of standardization in the process. Standardized methods, materials, analytics, and documentation can help reduce supply chain bottlenecks, increase efficiencies and lead to accelerated development timelines and smoother regulatory filings. In this podcast, we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials

In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview experts on up-and-coming 2022 trends in the bio/pharma industry.

Understanding the multiple benefits of prefabricated cleanrooms for aseptic filling applications and the pre-engineered solutions offered.

All drugs approved in the US marketplace went through an extensive, multi- million dollars, multi-year journey before being available to patients. In order to bring a new drug to the market place requires extensive resources, technical acumen, and an unbendable commitment to the goal. CDMOs are alongside pharma companies helping them navigate the process and mitigate risk. By choosing the right partnerships, you can give your drug production the competitive advantage it brings to the marketplace. Listen to Soojin Han, Director of the CLD group at Samsung Biologics, as she talks about what is the CDMO partnership and how Samsung Biologics can help many scientists for drug development to speed up the drug product to the marketplace and support many people's health life.

Drug development timelines are shortened by the corporate and clinical strategies of biotech and pharmaceutical companies to achieve proof-of-concept or to rapidly get to the market. For new drug entities entering clinical trials, selecting the right drug product depends on many factors, including the corporate and clinical strategy, and the physiochemical properties of the drug substance. This episode will consider time and cost for developing and compounding or manufacturing the different types of oral drug products dosed in early clinical trials.

Metamorphosis of topical products describes a product’s physiochemical changes that occur immediately upon administration to human skin. How does this process impact a product’s efficacy? And how do you mimic this process in vivo and in other clinical settings?

This podcast will examine peak deconvolution with photodiode array detectors and how a unique software function can separate peaks that are not resolved on-column, yielding better detection results and minimizing method development and analysis time. The podcast will explore the development of this tool with a leading pharmaceutical company and provide examples of how it can have an impact across a wide range of disciplines in the pharma/biopharma arena, from development to production.

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.