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Growing Potential: mAb Production With Fibra-Cel
| By Eppendorf
The market for monoclonal antibodies continues to grow steadily, but there are still bottlenecks in the development of new products, including long development times mostly due to R&D. Advanced bioprocess equipment that meets the specific demands of mAb-producing hybridoma can accelerate design and production, and reduce overall development costs along the way.
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DoE Bioprocess Development
| By Eppendorf
Eppendorf DASware is the effective route to design of experiments (DoE) in early-stage bioprocess development. Claudia M Huether-Franken and Sebastian Kleebank explain how the design software applies DoE to DASGIP parallel bioreactor systems.
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Taking the Strain
| By Eppendorf
Today, the rapidly expanding demand for vaccine products for viral diseases such as rabies has necessitated the development of more sophisticated production techniques based around cell culture systems. This article reviews vaccine production strategies, with a focus on rabies, looking specifically at the use of the Vero cell line - used worldwide and approved by the US Food and Drug Administration - as well as media technology and the bioreactor options available.
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Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
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Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
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Designing Wellness for Fun and Satisfaction: Gummies - Based Nutrition
| By Softigel pbr
The gummy delivery form for vitamins, minerals and supplements is the single-largest source of growth among the supplements category. Vitamin users report preference for gummy/soft chewable products because these offer not only pleasure and a fun experience, but efficacy and convenience. The selection of materials during the design process of the formula is critical for the final product in order to meet the expectations of the consumers, which is to find a healthy product that will give them a delicious reward as well. Based on the design and development process, this paper reviews review in detail the stage of selection of materials and validation as a critical phase to obtain a product that represents quality and stability as well as the specific requirements of the costumers and the consumers.
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Single-Use-Bioprocesses – Hype or Future Technology?
| By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes.
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Biosimilars in Emerging Markets Is It A Level Playing Field?
| By PRA Health Sciences
Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need.
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The use of GMP-Compliant Aluminium Pallets in your Industry
| By Muskita Aluminium Industries Ltd
Learn about aluminium. It will transform your logistics. It is: Anti static (unlike plastic), Antimagnetic, Food safe, No fire hazard (reduced insurance bills), Less weight than wood, -50o to +200o work environments, Watertight & resilient, Customized sizes and dimensions available, Permanent antimicrobial coatings available upon request, 100% recyclable, High residual value, Extremely durable, Easy to clean and sterilize, No fumigations needed, No UV damages.
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