Biosimilar White Papers
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Getting Your Investigational Drug Regulatory Ready
12/1/2020
Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.
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Single-Use Platforms Accelerate Viral Vaccine Development, Manufacturing
10/31/2019
Analysts predict the vaccine market could grow at as much as 10.3 percent through 2024 (CAGR). Single-use platforms might be pivotal to meeting that demand.
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Strategies To Address The Viral Vector Manufacturing Shortage
3/5/2020
Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.
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User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe
9/17/2020
Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.
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Navigating Regulatory And Development Milestones
9/17/2020
This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.
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Using In-Line Sensors For Real-Time Control
9/28/2020
There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.
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Integrated Tools For Upstream Process Intensification: Part II
10/27/2019
Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.
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Ensuring Consistency In The Supply Of Cell Culture Media
12/16/2020
This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.
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Can mRNA Disrupt The Biopharma Industry?
6/10/2020
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
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The Science Of Cell Therapy Thawing
4/5/2021
This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.