Top Stories
Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.
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The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.
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INTERPHEX 2016 KEYNOTE SERIES:
CONTRACT SERVICES MARKET
Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on the contract services market at INTERPHEX 2016.
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Industry News
The taskforce will work to identify opportunities to advance therapy manufacturing and the supply chain in the UK.
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A new 3D modeling and data-extraction technique improves X-ray crystallography analysis of proteins.
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Supplier News
The Matrix Alliance was formed by Vanrx Pharmasystems with inaugural members ARaymond Life, Daikyo Seiko, Datwyler Group, Ompi, Schott AG, Schott Kaisha and SiO2 Medical Products.
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Collaboration will provide for unified development and manufacture of antibody drug conjugates.
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Bio/Pharma News
The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.
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The commercial partnership aims to use digital health tools including sensors, apps, analytics, personal feedback, and education to assist patients in monitoring respiratory diseases.
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Regulatory News
Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.
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The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.
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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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FEATURED TOPICS |
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ANALYTICS
Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.
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MANUFACTURING
Q&A with David A. Steil, pharmaceutical market manager, Camfil Air Pollution Control.
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OUTSOURCING
As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.
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QUALITY
Standardized testing protocols are crucial for acceptance of single-use systems.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
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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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Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies.
Wednesday, April 27, 1:30 – 3:15 pm
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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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Webcasts
On Demand
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
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On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma
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on pharmtech tv
Cell Therapies
Biologics Development and Manufacturing Trends
FDA Applications and New Guidance Documents
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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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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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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