The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.
The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.
In this case study, Colbert shares the methodology behind its robotic implementation, from defining the scope through vendor selection, design considerations and project wins.
An Overview of RFID Technology for Retail and Healthcare Packaging
Obesity is a significant global health challenge that requires lifestyle changes and effective pharmacological treatments to overcome. Human glucagon-like peptide 1 (GLP-1) analogs, also called incretin mimetics, have emerged as a promising obesity treatment option. Additionally, oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering greater patient comfort and adherence to expand the therapeutic market.
This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.
Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations
Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.
Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.
A case study in converting a solution formulation of a protein into an oral solid dosage form utilizing a fluid bed granulation process and some of the complexities involved.
The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.
Drive growth by establishing integrated, AI-fueled lab systems and a data-driven corporate culture that’s ready and resilient, no matter what business challenges emerge tomorrow. Evolving to a Lab of the Future takes the right technologies, systems, and expert guidance.
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.
Localized treatment approaches for diabetic neuropathic pain management, like pregabalin liposomal topical formulations, offer a novel strategy by directly targeting affected areas. Liposomes enhance skin permeability and sustain drug release, delivering pregabalin efficiently to peripheral nerves while reducing systemic exposure. In a proof-of-concept study using an IVPT and a diabetic neuropathic pain rat model, improved skin penetration and significant reductions in mechanical allodynia and thermal hyperalgesia were shown.
Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing IVPT during formulation development of novel topical compounds to help select excipients and permeation enhancers that will properly deliver the drug into the desired layer of the skin or system.
Semi-solid dosage forms are complex drug delivery systems containing one or more active ingredients dissolved or dispersed uniformly in the product. Viscosity modifiers are polymers that hydrate upon interaction with solvents and impart an increase in viscosity. It is often difficult to choose the right grade of the polymer and identify the correct amount that produces a consistent viscosity. The video presentation and research poster discuss the importance of polymer selection during formulation development.
As today’s labs continue to evolve, the software solutions that support them must too. Likewise, laboratory and organization leadership must be open to the advance-ments available to them from modern technologies. In this white paper, learn how a SaaS-based LIMS modernization program optimizes data management, fosters collaboration, and improves decision-making to stay at the forefront of scientific innovation.
The efficiencies and insights of artificial intelligence (AI), machine learning (ML), predictive analytics, and other emerging technologies offer abundant opportunities to laboratories. To help customers leverage digital transformation and prepare for the lab of the future, LabVantage Solutions has devised a five-step process for successfully implementing and profiting from AI in the lab.
Illuminating industry trends, challenges and sentiments
Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.
Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.
Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products.
Parenteral drugs are becoming increasingly complex, creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.
