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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Selecting a Laboratory for Pharmaceutical Stability Testing
Author: Katherine Robertson
Sponsored By: Impact Analytical
Stability testing is an essential component during the multi-phase drug development process for small and large molecule API's and small and large molecule drug products. This whitepaper discusses the critical aspects to consider when selecting a stability testing laboratory provider. |
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Choosing the Best Microbial ID Contract Lab
Author: Mark Calmann
Sponsored By: Accugenix, Inc.
To justify a decision to outsource, an accurate analysis by the organization’s technical, quality and financial team is required. Presented in this publication are six critical elements to evaluate a contract laboratory service for microbial identifications. Outsourcing can drive cost savings, increase operational efficiency and leverage internal resources to focus on core competencies. |
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Analysis of aggregates in nasal spray suspensions.
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper reviews the importance of measuring particle size distribution and degree of aggregates in nasal spray formulations. Raman chemical imaging is presented as a greatly improved method of analyzing aggregates and agglomerates in nasal spray suspension formulations. Reviews the time and cost savings compared to current practice. |
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Outsourcing in Regulatory Affairs: Insights from the Top Pharmaceuticals
Author: Kristofer J. Spahr, Director of Regulatory Services
Sponsored By: TAKE Solutions
Economic and competitive pressures continue to motivate Regulatory Affairs organizations to explore outsourcing models as a vehicle for providing flexibility and efficiencies across the spectrum of Regulatory business processes. In a recent set of interviews with the heads of Regulatory Operations within five of the top ten global Pharmaceutical companies, this whitepaper reveals how they outsource submissions management activities to some degree and are looking at additional opportunities for further outsourcing expansion. Learn from their shared experiences in submissions management outsourcing and how they have realized positive financial impact in increased productivity, an ability to focus internal staff on higher value activities, and an increased flexibility in meeting submission schedule fluctuations. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Author: Jeff Phillips, Sr. Manager, Science and Marketing
Sponsored By: ALCONOX
Discussion on the benefits of employing aqueous cleaning in pharmaceutical manufacturing. The proper use of aqueous cleaning helps manufacturers minimize surface residue and makes cleaning validation easier. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: KIMBERLY-CLARK PROFESSIONAL* – (Damon Larkin)
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Mixing Powder 101: Basic Principles of Mixing
Sponsored By: Hosokawa Micron Powder Systems
On September 19, Hosokawa will host a free, online educational seminar on the basic principles of mixing and blending dry powders using a variety of batch and continuous mixing technologies. This webinar will explore the fundamental benefits and limitations of screw mixers, ribbon blenders, paddle mixing, high versus low shear applications, tumble blenders and other devices used for mixing applications. |
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Life Sciences Guidebook on Best Practice Compliance Solutions
Author: Tim Lozier
Sponsored By: EtQ, Inc
This paper provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company. |
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A morphous Local Structure and Property Prediction
Author: Simon Bates, Ph.D.
Sponsored By: Triclinic Labs, Inc.
Characterization of a variety of X-ray amorphous materials has shown that different types of local molecular order can exist for organic systems. In silico energy minimization can give potential local structures that might exist in the amorphous state. This approach is efficient, and useful for determining properties such as stability and local molecular order which can aid manufacturing and intellectual property considerations. |
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Developing Palatable Drug Products – Top 10 Myths of Taste Masking
Authors: Jeff Worthington, David Tisi
Sponsored By: Senopsys LLC
Developing palatable drug products can be a challenge for many APIs with aversive taste attributes. This paper provides an overview of the science and formulation principles of taste masking and dispels the ten most common myths. |
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What You Should Know About Lean Six Sigma Initiatives
Author: Jim Webber
Sponsored By: Compliance Insight Inc.
Investment in improvement can take many forms, e.g. capital improvements, equipment upgrades, product redesign, etc. All work is achieved through processes, so if those processes are ineffective and/or inefficient, then less than perfect outputs/cost are the result – and not just once – but over and over again! Resources are scarce, and always will be. Therefore utilization of the resources allocated to process improvement must be done with careful planning and within a well thought-out framework – if you want your organization to have a culture of superior performance. This paper lays out the framework – the foundation for an effective continuous improvement initiative. |
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