Article
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By Victoria Meyer,
BD Medical - Pharmaceutical Systems
Discover how a new product’s role is critical in determining combination products’ exposure to extractables and leachables.
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Article
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By Barbara Michaela Schulz,
GF
CMOs and CPOs currently face significant challenges, including strong competition, high-cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.
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Article
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By Joe Hoff,
AST
Small batch production will serve a critical role in the future of modern medicine. Learn more about maximizing process efficiency to reduce waste and improve yield for small batches of drug product.
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Article
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By Amber Sherrick and Troy Ostreng,
CPC
As autologous cell therapies and other targeted gene therapies work to scale up to commercial levels, connections that can be changed out in seconds represent a distinct advantage for industry.
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Article
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By Asmita Khanolkar,
SMC Ltd.
The formulations for novel therapeutics require flexibility to support adaptive sterile manufacturing and an integrated approach for a path from development, to small batch manufacturing, to commercialization.
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Article
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By Martin Gonzalez, Ph.D.,
Pfizer CentreOne
The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.
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Article
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By Dr. Brian Rodenhausen,
Anton Paar USA
Understanding the role of surface charge as a function of pH in membrane fouling, and how zeta potential measurements account for it, may help scientists evaluate product performance and regeneration efficacy.
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White Paper
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By Yves Massicotte,
Ropack Pharma Solutions
Learn what indicates whether a service provider has the capabilities desired by a drug sponsor to fulfill a company’s long-term goals and is committed to their success.
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Poster
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By Joseph Pate, Benjamin Kester, Claudia Berdugo, Yunsong Li, and Victor Vinci,
Catalent
This study involved a DoE approach to investigate effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze AEX Hybrid Purifier and efficiency of the Protein A capture step.
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Webinar
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By Kristin Lenberg,
Cytiva
Cryo-electron microscopy can help you determine structures for challenging proteins such as membrane proteins and larger complexes. This presentation offers tips on purifying your cryo-EM samples.
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Article
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Natoli Engineering Company, Inc.
Learn how choosing the right tooling can increase tablet output, decrease waste, and ultimately determine the success of a product launch.
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White Paper
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Lonza
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
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White Paper
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Mettler-Toledo Product Inspection
Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.
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Application Note
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TSI Incorporated
A new algorithm developed by the BioTrak Real-Time Viable Particle Counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.
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Case Study
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Cambrex
A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large-scale assets, multinational sites, and an exemplary quality systems/U.S. FDA track record.
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e-book
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Thermo Fisher Scientific
To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologic therapies throughout the development timeline.
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e-book
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Catalent
Understand the advantages of unit/bi-dose nasal delivery technology, the application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.
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Q&A
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Lonza
Dr. Michael Grass answers attendee questions from a recent webinar about the importance of using solid form screening and rapid formulation selection at an early stage of development.
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Q&A
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B. Braun OEM Division
This article asks the corporate vice president of quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.
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Webinar
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Thermo Fisher Scientific
Understanding the relevant solid-state properties and solid-liquid equilibria of a solid active pharmaceutical ingredient (API) are central to both chemical process and product development.
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