Top Stories
New rules from the US Treasury may force pharma to rethink using mergers as a tool to seek corporate tax havens overseas.
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Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf.
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The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.
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Industry News
The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.
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Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.
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Supplier News
Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.
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Sandoz Industrial Products GmbH will be renamed Corden BioChem and will be associated with the CordenPharma Group, ICIG’s pharmaceutical platform.
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Bio/Pharma News
The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).
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Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.
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Regulatory News
Inflectra is the second biosimilar to hit the market in the United States.
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Even though the organizers of New York's Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.
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FEATURED TOPICS |
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PEER-REVIEWED RESEARCH
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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TROUBLESHOOTING
Asking the right questions is crucial to establishing a biopharmaceutical facility design.
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DRUG DEVELOPMENT
Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.
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FILL/FINISH
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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Natoli Engineering Company, Inc., is recognized as the industry’s premiere tablet press tooling manufacturer. For 43 years we’ve been committed to delivering to our customers the highest quality tablet compression tooling at a fair price with unsurpassed customer service. Our expert staff will work with you to meet all your needs. Contact Natoli and find out for yourself.
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KEYNOTE SERIES AT INTERPHEX 2016
At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.
In a panel discussion, Industry experts will discuss how technology advances are addressing challenges in biopharmaceutical development including quality control of raw materials, implementation of single-use technologies, process monitoring, and downstream purification.
Tuesday, April 26, 10:15 am to 11:45 am
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Oral solid-dosage forms are the leading drug delivery method, but new development and manufacturing technologies are offering new options for patients. Experts will discuss advances in drop-on-demand manufacturing, polymer thin films for drug delivery, and manufacturing of minitablets.
Tuesday, April 26, 1–3:30 pm
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How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am
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Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm
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The largest, most influential biotech Convention in the world is coming to San Francisco, June 6-9, 2016. Experience powerful business partnering, benefit from invaluable education sessions and network with 15,000+ of biotech's best and brightest. See how the everyday becomes extraordinary — at BIO 2016.
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Webcasts
On Demand
Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Sponsored by Eurofins Lancaster Laboratories
On Demand
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs.
Sponsored by SGS Life Science Services
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
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on pharmtech tv
Addressing Drug Quality: Aging Facilities
Blow-Fill-Seal for Aseptic Processes
Pharma & Biopharma Outsourcing Association
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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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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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
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