Top Stories
Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.
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CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.
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Industry News
Stephen J. Ubl to succeed John J. Castellani as the next president and chief executive officer of PhRMA.
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The PDA report discusses qualification and operational handling of passive thermal protection systems.
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Supplier News
Merck Millipore’s collaboration with celares GmbH launches pegylation services for protein-based therapeutics.
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3M and Impel will collaborate to develop and commercialize Impel’s Precision Olfactory Delivery technology for enhanced central nervous system drug delivery.
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Bio/Pharma News
The results from an international study on nivolumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.
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The new facility will house the company’s expanding R&D operations.
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Regulatory News
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
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FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
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FEATURED TOPICS |
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EXCIPIENTS
As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?
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VALIDATION
This article discusses cleaning validation of equipment dedicated to the production of a single API.
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STANDARDS AND REGULATIONS
Manufacturers challenge details in new policies designed to promote access to important therapies.
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ANALYTICS
Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
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AAPS 2015 EXHIBITOR GUIDE
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One 2 One is a leading global injectable drug product CMO with more than 25 years of experience.
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Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization delivering proven scientific and operational excellence for solid oral dosage forms.
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MPI Research is a full-service CRO that has partnered with Sponsors targeting areas of discovery, safety, clinical, bioanalytical, and analytical sciences, for more than 20 years.
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Ropack Pharma Solutions is a competitive, full-service CMO providing contract solid oral dose formulation, process development, clinical and commercial manufacturing and packaging as well as distribution.
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The International Conference on Harmonization (ICH) Q10 model describes the elements of an effective Pharmaceutical Quality Management System (QMS). ICH Q10 enhances the scope of safety and quality within the Pharmaceuticals industry.
In this white paper learn about the basics of ICH Q10, how to apply the four pillars of ICH Q10 within your organization and how the QMS ensures ICH Q10 compliance.
 Download white paper now |
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Webcasts
On Demand
In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services |
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Tablet quality issues? You need this digital handheld microscope on special for a limited time at
 natoli.com/specials. You’ll find inspection equipment and more in the new edition of Natoli’s Tablet Compression Accessories Catalog – available for download along with Tablet Press Replacement Parts Catalogs on Natoli’s website. |
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On Demand
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
Sponsored by AMRI
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
 Learn more |
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on pharmtech tv
Trends and Concerns in Capsule Production
Application of External Lubrication in Tablet Production
Contract Services Market Trends
FDA Comments on Continuous Manufacturing
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Events
October 25–29, 2015 | Orlando, FL, USA
October 27–29, 2015 | Philadelphia, PA
December 08–10, 2015 | Philadelphia, PA
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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