FEATURED EDITORIAL
Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.
- How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
- 2024 CDMO Leadership Awards Opening Remarks
- Exclusive Interview: WuXi AppTec Responds To BIOSCURE Act
- Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
- Gene Therapy: Global Market Trends & Notable Developments
- Addressing Challenges In Serialization For Complex Therapeutics
- Don’t Blame The Molecule; You May Be The Problem
GUEST COLUMNISTS
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How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.
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Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.
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Gene Therapy: Global Market Trends & Notable Developments
New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.
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Addressing Challenges In Serialization For Complex Therapeutics
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview
This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
PHARMA OUTSOURCING WHITE PAPERS
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Strategies For Ensuring Biomanufacturing Resilience For Biologics
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Clear MRSA Infections At Single Low Doses
Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.
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Key Stages In mRNA-Based Therapeutic Development
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
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Cell Line Development: The Linchpin In Successful Biotherapeutic Development
Review key factors for building a reliable CLD strategy and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.
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Development And Regulation Of Veterinary Monoclonals
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Overcoming Inventory Challenges For A Complex, Global Study
- TFF For Laboratory And Process Development Applications
- Scale Up Strategy For Oncolytic HSV-1 Vector Manufacturing
- Meeting An Aggressive Go-To-Clinic Timeline
- Empty/Full Capsid Ratio Of AAV By Sedimentation Velocity – Analytical Ultracentrifugation
CONTENT COLLECTIONS
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out. In this latest e-book, Chief Editor, Louis Garguilo sits down with Francis Dumont just after he retired from Pfizer for an in-depth conversation on drug development and manufacturing outsourcing.
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