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By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), Joseph Zeleznik (IMCD)
This article is the third in a three-part series based on information from the new guide, Incorporation of Pharmaceutical Excipients into Product Development using Quality by Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to lifecycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.
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By Mark Durivage, Quality Systems Compliance LLC
Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected, requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.
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Article
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By Jim Springer, Steve Halpin, and Megan Kuikstra,
Albemarle
Every regulatory agency in the world might look at a sponsor’s filing a little differently. An adept CDMO partner can anticipate challenges based on its experiences and prepare sponsors for, or help them avoid, issues that may arise.
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Article
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By Andreas Stolle, Ph.D., and Peter Poechlauer, Ph.D.,
Thermo Fisher Scientific
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.
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Article
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By Courtney Morgret, Sabra Hanspal, and Evan Pasenello,
AbbVie
Antibody-drug conjugate (ADC) programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.
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Article
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By Vladas Algirdas Bumelis, Dominic Chow, Ph.D., and Rose Rhomberg,
Northway Biotech Inc.
When determining a cell line, a principal concern is whether the platform will express the desired protein in a quantity substantial enough to support preclinical work, clinical work, and commercial manufacturing. Understand practices for deciding between microbial, mammalian, and yeast platforms and clearing technical and regulatory barriers.
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Article
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By Kate Hammeke,
ISR Reports
Outsourcing motivations are important considerations to identify the best outsourcing approach and should influence the type of relationships your organization develops with CMOs.
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White Paper
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By Brandy Sargent, Cell Culture Dish in partnership with Lonza
The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1,000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell lines or processes. In our latest white paper, we help you to prepare for a successful transition to bring your drug candidate from discovery to the clinic.
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White Paper
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By Dr. Kashif Ghaffar,
Pfizer CentreOne Contract Manufacturing
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
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White Paper
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By Mats Lundgren,
Cytiva
The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring drugs reach patients safely and efficiently.
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Article
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Lonza
On April 8, 2021, join Lonza Pharma & Biotech as they discuss how spray drying can be used to address many of the challenges associated with today’s late-stage lung cancer treatments.
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Q&A
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Catalent
Understand risk mitigation, differences between innovator and biosimilar process development, and what to expect from development and manufacturing partners during drug product process development.
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Something positive and of great importance also flowed through 2020: a handful of new and expanding business and service models at contract development and manufacturing organizations. CDMOs are changing and providing drug sponsors — particularly virtual and small to midsize organizations — with more, and, it seems, improving, options.
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