Pharmaceutical Technology
May 02, 2020
Regulatory Watch
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Policy makers seek to ensure supplies of new therapies and to limit shortages.
May 02, 2020
From the Editor
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Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
May 02, 2020
Ask the Expert
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Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
May 02, 2020
Quality/Regulations
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Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
May 02, 2020
From the Editor
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In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.
May 02, 2020
Regulatory Watch
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EMA’s strategy for regulatory science has divided opinion amongst various industry bodies.
May 02, 2020
Quality/Regulations
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Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.
May 02, 2020
Product Spotlight
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Distek’s small-volume conversion kit for its Model 2500 Select bathless dissolution tester uses bathless heating technology and the continuous monitoring and control of the in-vessel temperature to eliminate the water bath in the dissolution tester.
May 02, 2020
Product Spotlight
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Inline high shear mixers from ROSS are available from 1 through 250 HP to accelerate mixing, emulsification, and homogenization in recirculation and continuous modes.
May 02, 2020
Product Spotlight
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Tosoh Bioscience introduced the SkillPak 1 mL and 5 mL pre-packed columns for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
May 02, 2020
Product Spotlight
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Smart Containers from SCHOTT work to improve reject management and line clearance via a unique identifier to create traceability throughout the manufacturing process.
May 02, 2020
Manufacturing
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Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.
May 02, 2020
Operations
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Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
May 02, 2020
Development
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Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?
May 02, 2020
Analytics
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Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.
May 02, 2020
Outsourcing
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Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.
May 02, 2020
Manufacturing
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A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
May 02, 2020
Cover Story: Bioprocessing Advances
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Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.
May 02, 2020
Development
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Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.
May 02, 2020
Peer-Review Research
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The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.
May 02, 2020
Issue PDF
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Click the title above to open the Pharmaceutical Technology May 2020 issue in an interactive PDF format.