Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
This presentation discusses the basic definitions of extractables and leachables, including details from a case study done using prefilled syringes and a second using a single-use bag.
Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies. Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting. Watch this webinar to learn more about the importance of and recent developments in lipid-based drug delivery systems, novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems, and using mechanistic studies and modeling to predict the impact of lipids on oral absorption.
In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.
A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.
To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.
The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more.
NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.
For over 40 years, NuAire, Inc. has provided the life science and medical research communities with valued products that are highly dependable, effective, and efficient.
The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.
Nitto Avecia Pharma Services is a cGMP contract development and manufacturing organization. Nitto Avecia Pharma Services' experienced and knowledgeable formulation team can reduce product risk and accelerate the drug development process by providing you with the optimum dosage form selection.