Featured Service :
The Promise of Science - Commercialized
Baxter’s BioPharma Solutions business offers clinical through commercial scale sterile manufacturing solutions and customized services to support your commercialization objectives.
Highly Potent Active Pharmaceutical Ingredient (HPAPIs or HPAIs) compounds including Cytotoxics and Antibody-Drug Conjugates (ADCs) present many challenges due to the complex handling required for toxic substances. BioPharma Solutions brings longevity of experience in handling complex sterile manufacturing challenges and our barrier technology ensures manufacturing precision.
BioPharma Solutions provides our clients with confidence of delivery, service, and integrity – knowing the work we do is ultimately vital to the patients you serve.
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Featured Webcasts:
Wednesday, December 7, 2011 2:00 PM EST
Optimizing Topical Drug Development and Manufacturing
Semisolid formulations, such as topical drug formulations, play an important role in drug delivery and development. Topical formulations can be used to treat local and systematic indications, offer ease of delivery, facilitate patient compliance, and avoid the problem of first-pass metabolism. Successfully developing a topical formulation requires an understanding of the physiochemical properties, such as release characteristics, composition of the drug-delivery system, and the nature of the drug-delivery vehicle. Manufacturing a semisolid dosage requires implementing a CMC (chemistry, manufacturing, and controls) strategy to ensure stability, photosafety, avoidance of product degradation, and minimization of process impurities. This 60-minute webcast will provide insight from leading industry experts on recent advances in topical drug formulations, the latest regulatory/pharmacopoeial requirements in product quality and product performance, and strategies to optimize manufacturing for topical drug products.
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On Demand Webcast
Industry Experts on the Design and Performance of Oral Osmotic Technology
Osmotic technology for oral drug delivery is now an accessible technology for controlled release oral drug delivery. Industry experts from H2 Pharm and Green Ridge Consulting will share their experience and knowledge on overcoming the design, formulation, process and regulatory challenges that may be faced developing osmotic delivery systems.
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Podcasts:
The Case for Upgrading existing HPLC Assays to UPLC
Eric Hill of Impact Analytical discusses the emergence new analytical technologies, specifically UPLC. He outlines the advantages of converting existing HPLC assays to UPLC, including both increased performance and cost savings. With minimal upfront investment, the long term gains are significant.
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Step-by-Step Validation for Bio/Pharmaceuticals: Meeting New Regulatory Expectations
FDA published the long-awaited Process Validation: General Principles and Practices guidance in January 2011. Industry has since been scrambling to make changes to its validation plans and programs to comply with new regulatory expectations. This 3-part podcast series provides listeners with best practices as well as practical insight into implementation of and regulatory expectations for a start-to-finish validation plan in the bio/pharmaceutical manufacturing industry.
Part 1 focuses on how to prepare a process validation plan; Part 2 will address how to implement changes to current process validation programs based on the new FDA Process Validation guidance; and Part 3 will cover how to meet common challenges when performing a cleaning validation program for bio/pharmaceuticals, including practices tied to the new guidance. Risk-based approaches and related international guidelines will be discussed.
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CPhI Show Daily Podcast Series
European Editor, Rich Whitworth interviews key organizational leaders to explore new product launches, developments and technical highlights to be found at the 2011 CPhI Worldwide and ICSE exhibition (Posted October 2011).
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Raw Material Identification in the Warehouse Using a Portable Spectrometer
For some time Nutricia has been interested in moving the NIR testing for raw materials from the laboratory to the warehouse; however there was nowhere suitable in the warehouse to locate a laboratory instrument. Using the microPHAZIR RX analyzer is a massive benefit to them as it enables the lab analysis to be taken to the point of need.
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Sponsored by: Thermo Scientific |
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Protect Your Scientific Intellectual Property for the Long Term - Can your electronic research IP records withstand a court challenge?
As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your scientific Intellectual Property. Protecting the integrity and legally defending the authenticity and ownership of such electronic data is critical to your organization’s long-term success. But if you are overlooking this protection in your lab management workflows, you risk losing patent ownership, revenue and consequently your business, if you can't prove authenticity and time of creation, hence your ownership, in a court of law. This new whitepaper from IP Protection Leader, Surety, explores these concepts and requirements, and discusses how you can implement simple, cost-effective controls to achieve legally defensible scientific IP for the life of the research records.
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Sponsored by: Surety |
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