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Entering New Domains for 3D Printing of Drug Products

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

How Codexis is Redefining Pharma Biocatalysis

Mandy Vink, VP of Business Development at Codexis, explains how the company leverages over 20 years of expertise in small molecule APIs to advance biocatalysis across pharma.

Picodroplets for Biologics Discovery and Scale-up: A Novel Automation Approach

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

Photometer Calibration: Calibration Error Due to Errors in Gravimetric Standard of Measurement

This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

Lipid-Based Formulation in Customized Enteric Capsule for Oral GLP-1 Receptor Agonist Peptide Delivery

Multiple factors affect oral delivery of therapeutic peptides such as acidic and enzymatic degradation in the upper gastrointestinal tract and poor intestinal Permeability.

Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics

Rapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.

Executive Summary: Commercial Tech Transfers in OSD Manufacturing

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

The Benefits of SaaS for Laboratory Informatics

LabVantage is advancing software as a service (SaaS) for the laboratory information management system (LIMS) market to provide laboratories with reduced costs and pre-validated solutions that facilitate scalability and faster speed-to-market for pharmaceuticals

Lilly Invests $3.5B in Pennsylvania Injectable Medicine Facility

Eli Lilly will invest $3.5 billion in a Pennsylvania facility for injectable weight-loss medicines, creating 850 new jobs and starting by 2031.

Multi-Compendial Compliance for Pharmaceutical Excipients–Part 2: A Detailed Assessment for Specification Equivalence

This paper provides a technical assessment of compendial tests commonly found in the European Pharmacopoeia, the United States Pharmacopeia–National Formulary, and the Japanese Pharmacopoeia, detailing differences between the methods and acceptance criteria, and the potential impact of these differences on multi-compendial compliance.

BioDuro is Redefining CRDMO Partnerships With End-to-End Innovation

How BioDuro is expanding its global CRDMO footprint by improving integrated capabilities and delivering high-quality, end-to-end solutions for drug development and manufacturing

Streamlined Product Development Leveraging Pharmaceutical Classification Models

Ensuring the Supply Chain through Purchasing Controls

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

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Making Critical Therapies More Accessible with Nasal Sprays

Entering New Domains for 3D Printing of Drug Products

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Fresenius Kabi Contract Manufacturing: Focused on Your Success

Saleem Farooqui of Fresenius Kabi explains how the company is addressing today’s pharmaceutical manufacturing needs. Watch this video to learn how these capabilities can help bring products to market successfully.

Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access Programs

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

Sustainable Alternative: PFAS-Free-TPE for Pharmaceutical Stoppers

Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more sustainable product.

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

Fedegari’s FOB5 Redefines Sterilization with Compact Design and Full GMP Compliance

Discover how Fedegari’s FOB5 is redefining sterilization with compact design, GMP compliance & high-containment capabilities.

Rare Disease Therapies: From Niche Experiment to Strategic Growth Engine

In part one of this four-part series regarding rare diseases, the author explores how rare disease treatment development evolved from a niche area to a cornerstone of biopharma growth.

Collaboration and Innovation are at the Heart of AustinPx’s ASD Workshop

The biannual AustinPx Amorphous Solid Dispersions (ASD) Workshop is a place for collaboration and innovation. Hear firsthand from attendees about challenges and insights from the front lines of amorphous drug development.

A Discussion: In Vitro Release Testing and Its Application and Use in Generic Topical

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.

Accelerating HTA Readiness with Generative AI

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access Programs

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.