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By Louis Garguilo, chief editor, Outsourced Pharma
We’ve reached the final four of the Eight Core Values devised some years ago to propel the outsourcing industry to the highest standards of internal and external excellence. Not only do they remain applicable to any business today, you may be need these precepts more than ever.
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By John Hoekman, Ph.D., Impel Pharmaceuticals, Inc.
Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.
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By Lea Joos, The Government of Upper Bavaria
It is sometimes astonishing how often pharmas and biotechs commit similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
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Article
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By Jim Huang, Ph.D., and Shauket Ali, Ph.D.,
Ascendia Pharma
Explore the decision for selecting the right and best suited technology for formulating a complex molecule.
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Article
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By Anthony Bucci, Ph.D.,
West Pharmaceutical Services, Inc.
Examine a case study where two 20 mm vial CCSs were compared using the DeltaCube Modeling Platform and experimentally shows the link between prediction and real performance.
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Application Note
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By Catalin E. Doneanu, Chris Knowles, Matt Gorton, Henry Shion, Joseph Fredette, and Ying Qing Yu,
Waters Corporation
We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.
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Application Note
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By Anshuman Bansal,
MilliporeSigma
How much quicker and easier would it be if we could know a process’s health by looking at a single metric rather than checking hundreds of parameters?
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Article
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ISR Reports
Sponsors will see success in their CDMO partnerships by dedicating time and effort to establish a plan that identifies outsourcing drivers, selecting a model that matches company needs and resources, establishing a decision-making process and group, and designating key selection criteria. Using these steps, drug developers can build strategic outsourcing relationships where their internal expertise is complemented by external CDMO resources.
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Article
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KBI Biopharma
As the industry utilizes more sophisticated protein structures in complex biologics development, how do we optimize the affinity chromatography step to ensure higher yields for more efficient biomanufacturing at scale?
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Article
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Cytiva
Aseptic filling has changed. High-speed machines designed for a single format are no longer suitable. Learn how aseptic filling work cells provide flexibility at the core of a standardized system.
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Article
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Thermo Fisher Scientific
Learn more about inclusions for your total cost of ownership, calculations to consider for cGMP chemical supply chain TCO, and how one midsize CDMO improved cGMP chemical supply by outsourcing.
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e-book
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Catalent
Combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.
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Podcast
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Lonza
Explore how to assess the risks of properly developing therapeutic drug candidates, including employing computer modeling tools, novel cell-based assays, and a full economic viability appraisal.
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Webinar
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Pfizer CentreOne
Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.
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Webinar
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Thermo Fisher Scientific
Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.
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Webinar
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Cytiva
Watch this webinar to learn about emerging technologies and approaches for intensifying mAb purification and diversifying bispecific antibody, fragment, and ADC pipelines.
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Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.
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Connect With Outsourced Pharma:
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