The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
- Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
- Emerging Market Trends For APIs
- Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
- Global Market Trends For Drug–Device Combination Products
- New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters
- Survey Results Show What Could Finally Make Sustainability Stick
- Have You Adopted A Manufacturing Execution System Yet?
Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
Emerging Market Trends For APIs
The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.
Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
Global Market Trends For Drug–Device Combination Products
Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.
New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters
The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.
Survey Results Show What Could Finally Make Sustainability Stick
Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.
Have You Adopted A Manufacturing Execution System Yet?
Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.
BIOSIMILAR WHITE PAPERS
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.
COGs Process Economics For Autologous Cell Therapy8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.
A Risk-Based Approach To The Development Of An Injectable Combination Product3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
Quality by Design (QbD) for Adeno-Associated Virus (AAV)10/14/2021
CMC is but one obstacle to gene therapy regulatory approval. Here we review a framework for QbD assessment of AAV products within the Chemistry Manufacturing and Controls documentation.