Pharmaceutical Technology Europe E-Alert

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7 January 2015

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In this special edition of the Pharmaceutical Technology Europe e-Alert, the editors share the top feature articles and news stories of 2014, as selected by readers.

Top Articles of 2014

Data Integrity in the Analytical Laboratory Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA. More...

The Future of Dosage Forms How will the move to more specialized and personalized medicines impact drug delivery and dosage forms? More...

Qualifying Personnel to Visually Inspect Cleaned Equipment Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed. More...

Is a Sample Size of n=6 a 'Magic' Number? Statistical analysis shows how much testing is needed to deliver a reliable estimate result. More...

Advances in Controlled-Release Drug Delivery
Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena. More...

Freeze Drying Protein Formulations
Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals. More...

Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. More...

Optimizing Solid Dosage Manufacturing
Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules. More...

The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare. More...

Control Strategies for Synthetic Therapeutic Peptide APIs—Part I: Analytical Consideration
USP evaluates quality attributes for synthetic peptides. More...

Top News of 2014

FDA Issues Warning Letter to GSK Biologicals GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility. More...

FDA Updates Analytical Validation Guidance FDA provides recommendations for submitting analytical procedures and methods validation data. More...

FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market FDA adds Ranbaxy’s Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location. More...

FDA Releases Guidance on CMC Postapproval Changes New guidance from FDA asks for documentation of CMC postapproval manufacturing changes. More...

FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility. More...

Merck Receives Accelerated Approval of the First FDA-Approved Anti-PD-1 Therapy KEYTRUDA was approved for the treatment of unresectable or metastatic melanoma and disease progression. More...

Teva Announces New Organizational Structure and Acquisition of Labrys Biologics Teva assigns new executive positions and acquires Labrys Biologics. More...

Report: Branded Biopharms Most Exposed to Biosimilar Competition Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition. More...

Merck KGaA Acquires Sigma-Aldrich for $17 Billion Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich. More...

Sanofi Board Votes to Remove CEO Christopher A. Viehbacher The board of directors at Sanofi unanimously agree to remove Sanofi's CEO. More...

USP Announces Revision Timeline, Effective Date for Elemental Impurities Limits and Procedures USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015. More...

Lundbeck CEO Resigns Due to Code of Conduct Breach Ulf Wiinberg has resigned as Lundbeck's CEO over unapproved acceptance of shares in a biotech company. More...

FDA Accepts First Biosimilar Filing Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009. More...

EMA Publishes New Guidance for Qualified Person's Declaration on GMP Compliance of API EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain. More...

Ireland: The Gateway to Biopharma's Future Despite recent changes in corporate tax law, Ireland remains a valuable and attractive partner in the development and manufacture of biopharmaceuticals. More...

Webcasts
Enhancing Quality and Process Efficiency Using Continuous Manufacturing Technology for Drug Substance and Drug Product Tuesday, Jan. 13, 2015 — 11 am EST/10 am CST/8 am PST Sponsored by Patheon

Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle On Demand Sponsored by SGS Life Science Services

More Webcasts

Event Profile

6th Annual Global Drug Delivery & Formulation Summit
9 – 11 February 2015 \| Dusseldorf, Germany This event is the most powerful way you can address the biggest issues with your current delivery and formulation programmes. The attendees make up an invaluable network of qualified specialists and leaders. The innovative and effective networking schedule allows you to meet and seek advice from those with answers to your questions. Read more

Pharmapack Europe 2015: innovation, networking & education in pharmaceutical packaging and drug delivery technologies
11 & 12 February 2015 Paris Expo, Porte de Versailles (Hall 5) More than 370 leading suppliers in pharma packaging and drug delivery technologies have already announced their participation and will meet with international pharmaceutical companies’ buyers and R&D managers at the 14th edition of Pharmapack Europe, taking place on the 11th & 12th February 2015 in Paris. Read more

Reference Library

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo
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. ... Click here

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