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Top Pharmaceutical Technology News Stories of 2017
AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
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Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
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A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
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2018 PDA Annual Meeting
The 2018 PDA Annual Meeting will deliver the same high-quality content attendees expect in a NEW meeting format that starts on Monday afternoon. Delve into the future of bio/pharmaceutical manufacturing with the latest updates on the end user/patient perspective, innovative manufacturing strategies, and disruptive technologies. The industry's increased use of big data, artificial intelligence and robotics will also be explored.  Learn more and register today. |
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The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
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FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.
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The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
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After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
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The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
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Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.
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The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.
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Top Pharmaceutical Technology Feature Stories of 2017
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This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
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Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.
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Design of experiment plays a crucial role in the optimization process of formulation development.
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In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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Advances in process analytical technology have been achieved, but significant challenges remain.
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The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of analytical quality by design concepts.
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Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.
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Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
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Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.
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Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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