Through the adoption of a data driven and automated CMC Dossier generation process, pharmaceutical companies can reduce time-to-market while delivering significant cost savings to the organization. Eliminate errors, duplicate data entry and verification, create a digital chain of evidence and significantly reduce time spent on CMC authoring.
Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point.
You have your drug substance and need a parenteral formulation to administer it. This podcast will focus on the key factors to consider when choosing the ideal parenteral manufacturing CDMO partner.
Jeroen De Haas, Senior Product Manager at LabVantage Solutions discusses how advanced analytics such as AI are moving into the lab, helping biopharmaceutical organizations draw far greater actionable insights from a broader array of data. Intelligent LIMS leveraging these advanced analytics are at the heart of a lab’s digital transformation.
How Pfizer’s external-facing research and development scientists uncover the most promising emerging therapy concepts and ideas in the pharmaceutical landscape.
In a new podcast titled, “DeltaV™ Spectral Process Analytical Technology (PAT): Achieve Real-Time, Closed-Loop PAT in Manufacturing,” find out how embedding PAT directly into the control system enables life sciences manufacturers to take a simplified approach to achieving real-time manufacturing, compliance with confidence, greater ROI and delivery of quality treatments to market faster.
Join Christian Jones, CCO of Nanoform, as he discusses what it truly means to be patient-centric in the modern pharmaceutical industry. Discover the challenges pharma companies are facing as they switch focus, as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.
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.