Top Stories
The denial marks a setback for Amgen, whose Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.
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Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.
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Industry News
BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen.
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The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.
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Supplier News
The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.
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FuelCell Energy plans to install a 5.6 megawatt fuel cell power generation system for Pfizer to provide reliable and low carbon electricity and steam for its 160-acre R&D facility in Groton, CT.
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IVT’s Validation & GMP Week, taking place March 15-16 in Puerto Rico, provides the most current regulatory updates and best-in-class validation strategies to implement enterprise-wide. It has never been more critical to understand up-to-date trends and procedures in implementing statistics in validation, validating data and quality metrics. This conference covers implementation procedures for equipment, utilities, cleaning, computer systems, analytical procedures, and other critical GMP topics.
 www.cbinet.com/ValWeekPR |
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Bio/Pharma News
Adimab and Merck have entered into a definitive agreement to transfer Adimab’s antibody technology to Merck Research Laboratories.
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Takeda Pharmaceutical Company and enGene have entered into a strategic alliance to develop novel therapies for specialty gastrointestinal diseases.
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Regulatory News
A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.
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FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.
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Best Practices for Effective Product Transfer
ON-DEMAND
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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FEATURED TOPICS |
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PEER-REVIEWED
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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SUPPLY CHAIN
Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.
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FORMULATION
Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.
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TROUBLESHOOTING
The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.
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Understanding Water Activity to Ensure Microbial Safety and Product Stability
LIVE WEBCAST: Wednesday, January 27, 2016 at 11:00 am EST
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WebcastS
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New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC’s role as a functional excipient.
Sponsored by Capsugel
On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Thursday, February 11, 2016 at 8 am PST / 10 am CST / 11 am EST
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
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on pharmtech tv
Tablet Coating
Application of External Lubrication in Tablet Production
FDA Comments on Continuous Manufacturing
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Events
January 24-27, 2016
February 2–4, 2016
February 21-25, 2016
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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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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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