Newsletter | November 23, 2021

11.23.21 -- Can RWE Transform Healthcare? Recent FDA Activities Say Yes

 
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How Scale-Up Benefits A Clinical Program To Get Results

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market.

Optimizing CDMO Technical Transfer

Learn how a CDMO helps biopharma organizations predict and mediate technical transfer risks before they become costly, time-consuming problems.

Painless Precision For Downstream Automation

OCELOT System Control, a new automation software platform, offers all the capabilities of its competitors but with a user-friendly platform that simplifies implementation and operation.

Applications For High Voltage Leak Detection You Might Not Be Aware Of

High voltage leak detection (HVLD) is capable of handling any product as long as the container is made of electrically insulated material and the product contains an electrically conductive solution.

Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

Achieving Large-Scale Ophthalmic Production

Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

Using Parallel Evaporators To Escalate COVID-19 Test Kit Preparation
As the world scales up production of polymerase chain reaction (PCR) test kits to aid the global fight against COVID-19, improvements to the workflow for producing test kits are urgently needed to increase the efficiency of test kit production.
Leveraging Serialization Investments With Aggregation

Although most current legislation concerning traceability of pharma products focuses on serialization rather than aggregation, the latter is an essential component of internal and external traceability of products.

Local Treatment Of Non-Small Cell Lung Cancer With A Spray-Dried Bevacizumab Formulation

Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

How Collaboration Transformed A Generic Into A Best-In-Class New Drug
Learn how a drug developer collaborated to transform a generic solid API into a commercial, sterile injectable approved by regulators.
A Guide To Weigh Cell Technologies For Pharma And Food Industries

For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable.

Enabling Engineers With Data Science

Engineers and subject matter experts within operations settings are tasked with driving operational excellence to improve quality, safety, and throughput in production operations. As an IT professional, supporting these efforts is imperative as operations leaders grapple to get the most out of investments in technologies that generate and use large volumes of data.

Modularity Is Key To Flexibility, Scalability In Drug Delivery Device Assembly

How can machine vendors meet customer requirements and streamline drug delivery device assembly from the prototyping phase up to commercialization? The answer is modularity.

Dual-Lane Checkweigher Tackles Tube Line Automation Needs

Teligent produces a range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a checkweigher with a two-lane configuration.

Keys To A Successful Rapid Commercial Launch

Combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.

Feeder Advancements Improve Cleanability And Automation

This webinar is designed to educate attendees on the newest criteria and engineered solutions available in feeding and material handling for quick and efficient product changeover.  

IND Submissions In China: What Is Different Than Other Territories?

The number of regulatory submissions in China is increasing. This webinar provides an overview of Chinese regulations with a specific focus on data and requirements for clinical trial applications.

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