Newsletter | January 13, 2022

01.13.22 -- Calculating Process Capability Of Cleaning Processes: Analysis Of Total Organic Carbon (TOC) Data

 
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Data Integrity And Data Access Control For Filter Integrity Test Instruments

Assuring the integrity of critical records when generating and maintaining them is essential to the development and production of high-quality, safe, and effective drugs. This technical paper reviews the evolving regulatory requirements and standards for data integrity and how they can be applied to filter integrity test instruments. 

Key Considerations For Labeling Your Cell Or Gene Therapy

As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

Top Four Considerations For Tech Transfer Performance

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

The Value Of Expertise In The Aseptic Fill/Finish Of Biologics

Aseptic fill/finish manufacturing is critical for highly valuable biologics drug substances. With vast amounts of time and resources invested upstream, loss-resulting errors at such a late stage can be catastrophic.

Implementing Global Supply Risk Mitigation Through Multisourcing

Multisourcing and other raw material and platform strategies contribute to a reliable supply for patient medications by deftly managing on-the-fly change within client processes.

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?

Real-time viable particle monitoring instruments have been available for over five years. This white paper intends to describe this technology and how it is used to detect viable particles in real time.

Spray-Dried Dispersions Enable Local Delivery For Lung Cancer

Spray drying is particularly advantageous for manufacturing particles in the inhalable range of 1-5 microns. Learn more about spray drying through two case studies of inhaled dry powders.

Boost Performance With A Chromatography Resin Update

Although workhouse resins developed in the 1980s are still used in many processes worldwide, you could be missing out on better productivity and performance. Find an answer to the question, "How do I know which modern resin to use in my new projects?"

Excel IV: An Evolving Market Affirms The Value Of An Established Offering

These containers can be delivered with a full line of solutions used in clinical settings, including basic saline, heparin premix, and lidocaine. The chemistry used to produce the container uses neither polyvinyl chloride (PVC) nor the plasticizer DEHP.

Scale-Up And Biologics License Application (BLA) Planning For Microbial Biomanufacturing

Early planning for scale-up and BLA activities for your microbial-based product can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Role Of Organic Co-Solvent (t-Butanol) In Frozen And Freeze-Dried Formulations

In the last year, more than 40% of drugs approved by the FDA have been lyophilized. Lyophilization stabilizes the drug product and enables a longer shelf life at room temperature with easier transportation. However, the processing steps (freezing, primary drying, and secondary drying) involved in the lyophilization process can expose the proteins to various stressors and harsh conditions, leading to denaturation, aggregation, and, sometimes, a loss of functionality. In this article we examine the thermal characterization of an organic solvent, tert-Butyl alcohol (TBA), used as an excipient during the freeze-drying process.

Enhanced Single-Use Fermentor (S.U.F.) For Improved Cooling And Oxygen Mass Transfer
As users of HyPerforma S.U.F.s continually push to increase production levels in their fermentors, we continue to increase our product capabilities to meet their needs. Here we share how we have further enhanced the HyPerforma S.U.F. to meet higher cooling requirements of exponentially growing, high oxygen-consuming cultures.
Development Of An Aseptic Transfer System

The Bio valve was designed to provide the safe transfer conditions in a sealed environment, eliminating the requirement for large-area high-grade cleanrooms surrounding the process. This article discusses the options available for the sterilization process in the current market and the results that drove the design of the Bio valve the industry knows today.

Glovebox Design Encloses Milling Processes

A manufacturer required a glovebox that would enclose milling processes done by either a Fitzmill L1A or a Quadro Comil. Read how the design features allowed the operator the access and flexibility that they needed while achieving the containment requirements that were required.

Improved Bioavailability In 12 Weeks

A lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured three-step approach.

Engineering Drug Release In EVA-Based Implants

Discover the Vitaldose EVA platform for creating injectable and implantable long-acting drug delivery products. Learn the technology's technical basics and how it can be used to deliver small molecules, peptides, and biologics, including some predictive modeling of the release of drugs from EVA.

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