Top Stories
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
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Stefan Oschmann will replace Karl-Ludwig Kley as chairman of the executive board and CEO of Merck KGaA.
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Industry News
Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.
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Biogen, Sobi, and the World Federation of Hemophilia collaborated to enable a sustained humanitarian supply of hemophilia treatment to developing countries, and the first shipments have begun to arrive.
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Supplier News
Test results of the new multilayer plastic container show that it offers sensitive pharmaceuticals extra protection against moisture vapor and oxygen permeability.
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Contract manufacturer PiazaBio announces services for Western Pharma companies seeking to enter the China market.
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Bio/Pharma News
BASF will develop a higher-purity version of poloxamer 188 for Mast Therapeutics, a biopharmaceutical company.
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Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer's disease.
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Regulatory News
The European Medicines Agency plans on using existing patient registries to collect information on medicines.
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The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.
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FEATURED TOPICS |
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FORMULATION
New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.
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PACKAGING
Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.
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MANUFACTURING
Using ISA-88 batch architecture standards can simplify communication between manufacturing execution and process control systems to improve the efficiency of such human activities as sampling and electronic batch recordkeeping.
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BIOLOGICS
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.
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AAPS 2015 EXHIBITOR GUIDE
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Ascendia is a specialty pharmaceutical company dedicated to developing enhanced formulations of existing drugs, and enabling formulations for early stage drug candidates.
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Biddle Sawyer, with over 60 years of distribution and manufacturer's representation, offers formulation solutions.
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Capsugel is a global leader in providing innovative, high-quality dosage forms and solutions for the health care industry.
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Catalent's Optiform Solution Suite is designed to accelerate more molecules to the clinic and beyond by facilitating a simpler, more economical R&D process at the earliest phases of development.
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Chemic Laboratories, Inc. is a full service cGMP/GLP contract analytical chemistry laboratory.
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CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services.
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EMD Millipore offers products for pharmaceutical and biotechnology companies to develop and manufacture drugs efficiently.
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Eurofins Lancaster Laboratories supports all functional areas of bio/pharmaceutical manufacturing.
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The EUDRAGIT product range provides broad flexibility for targeted drug release profiles.
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The FE75 double-sided rotary tablet press is equipped with up to 115 punch stations to produce more than 1.6 million tablets/hr.
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Don't overpay for tablet press replacement parts.
Natoli Engineering stocks an extensive inventory of tablet press replacement parts and turrets for virtually all press types that outlast, outperform, and are less costly than original equipment manufacturers' parts. Download Replacement Parts Catalogs for Cadmach, Colton, Fette, Kikusui, Kilian, Korsch, Manesty, Natoli and Stokes machines online or request a quote through our website.
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Webcasts
On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by Baxter |
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Advance the LC Characterization of Bio-therapeutics – Agilent eSeminar Series.
Presented by industry experts we cover UHPLC techniques for advanced characterization of therapeutic biomolecules using state-of-the art technologies:
• Improved Speed and Accuracy of mAb Primary Structure Characterization
• Does N-Glycan Need to be Complicated?
• Size Exclusion Chromatography Strategies for the Characterization of Protein Biopharmaceuticals
• Accurate and Reliable Characterization of Impurities in Oligonucleotide Therapeutics
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On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.
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Optimizing M&A Integration for Custom Success: The CMO Perspective
LIVE WEBCAST: Thursday, October 29, 2015 at 9:00 am ET
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on pharmtech tv
Addressing Pharma Industry Issues
Trends and Concerns in Capsule Production
Pharma & Biopharma Outsourcing Association
Application of External Lubrication in Tablet Production
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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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Thermal Sintering for Controlled Drug release of Hydrophilic Drugs
LIVE WEBCAST: Thursday, October 22, 2015 at 10 am EDT
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REFERENCE BOOKS |
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A compilation of informative, useful articles from Pharmaceutical Technology 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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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.
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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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