Newsletter | January 7, 2021

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies

 
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Navigate The CMC Regulatory Landscape For Cell And Gene Therapies

The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

Critical Considerations When Selecting A Vented Balance Enclosure

This paper discusses the primary benefits of the vented balance enclosure, which is critical to the safe and effective weighing of potent powder compounds, APIs, and nanomaterials. 

Preventing Sticking And Picking Through Tablet Design

Sticking or picking issues are often not detected. Prevent unanticipated problems during scale-up and full-scale production by considering tablet compression issues before tablet designs are finalized.

A Modern Take On Cell Therapy Logistics

Here are my highlights from an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.

Art And Science Of Tech Transfer: Establishing The Path For Success
Pharmaceutical technology transfer often invokes images of a complicated set of activities required to transfer the development and manufacturing of a product, or products, from one facility to another. This article shares five features of a successful tech transfer; they are imperatives that we have learned with a focus on drug sponsors working with CDMOs. These imperatives, when applied to project management operations, can deliver extraordinary results.
The Physical Properties Of An API And Drug Product Performance

An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

Five Key Functional Challenges Can Affect Oral Drug Products With An Immediate-Release Profile. Ready-To-Use Excipients Can Now Solve Them All

The market for oral drug products with an immediate-release profile continues to move toward the development of more complex dosage forms designed to address specific functional or application requirements. While each formulation is different, customers most commonly want solutions to some combination of these five key challenges.

Ensuring Safe Handling Of High Potency Products
Due to the high potency of APIs, machine operators have to be protected, while, at the same time, humans are a high source of product contamination. In pharmaceutical manufacturing facilities, isolators are becoming increasingly important as they can achieve the desired level of protection and security.
Traditional Sensors, Single-Use Systems: Bridging The Connectivity Gap

The secure, leak-free connection of sensors to single-use assemblies is paramount in ensuring both the accuracy of the measurements taken and the protection of the manufacture of expensive drug products.

How To Select The Right CDMO For Your Tech Transfer

Selecting the right CDMO to properly execute your tech transfer is critical for ensuring optimal process reproducibility that preserves the intended quality, efficacy, and safety of a drug product.

Mitigating Risks Associated With Single-Use Systems: Critical Considerations

If you plan to utilize a single-use system for your product manufacturing, there are specific factors that must be followed, all of which play an important role in determining your project’s total risk profile.

Why Don’t OEM Recommendations Work For Maintenance?
During the design, build, test phase of an asset’s life cycle, many organizations will choose to start with maintenance and spare parts recommendations from the vendors and manufacturers of the equipment. Nearly without fail, a few months or years pass, and the asset begins to fail unexpectedly. Why does this happen, and how can we make this stop?
Curing Your Complex Oral Solid Dose Challenges

Pfizer CentreOne’s oral solid dose experts Amy Trotch and Kieran Coffey’s webinar on engineering advancements for complex oral solid dose (OSD) coatings offered insight into the range of coating techniques and technologies available today and how these coatings can be scaled and transferred effectively for commercial manufacturing. Here you will find a transcript of the Q&A portion of the webinar.

Extrusion-Spheronization, Engineered For Today’s Controlled Release Forms

Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex oral solid dose (OSD) therapeutics.

Accelerate Your Pipeline With CDMO Collaboration

Pharma companies are looking to collaborate with CDMOs to augment their capacity and expertise, refine their processes, and, ultimately, shorten their time-to-market. This e-book is designed to help you determine if working with a CDMO is right for you — and if so, you’ll discover the best practices that make working with a CDMO as efficient as possible.

Catalent Keeps On Track In Compliance With Track And Trace Solutions

Catalent Biologics works closely with its customers from early development through commercial supply. To comply with serialization regulations, Catalent’s Bloomington, IN, U.S. team needed an affordable track and trace solution that could be easily added to their vial and syringe packaging suites.

Drug Manufacturer Crystallization Deviation Investigation

During a commercial campaign, a small molecule pharmaceutical company needed to investigate the cause of crystallization deviations at the end of its batch processing. The manufacturer’s engineering team was experiencing difficulty in trying to get to the root of the problem using spreadsheets. By implementing a root cause analysis to determine the changes that might explain the circumstances surrounding the slow-filtering batch, they were able to dramatically shorten the analysis time for the engineering team through integrative calculations and data analytics.

Depot-To-Patient Service Overview

This infographic provides an overview of Fisher Clinical’s depot-to-patient solution to support decentralized clinical trials in the U.S.

Three-Year Rolling Average: Small Molecule API Customer Loyalty

In Q4 2019, ISR asked sponsors who outsource small molecule APIs to offer insight into customer loyalty. CMO loyalty is computed as an index that consists of overall satisfaction, willingness to recommend, and the likelihood of using the contract manufacturer again. The data below show companies with ten or more responses from recent users for each of the past three years and an industry average derived from all CMOs included in the research; their loyalty component scores are aggregated, averaged, and then weighted based on the number of customer interactions.

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