Newsletter | November 17, 2020

11.17.20 -- Human Performance In Biopharma Operations -- Your Problem Isn't Error

Featured Editorial
Industry Insights
2020 Cold Chain Forecast: Ushering In The Next Decade Of Change

As we cross the threshold into a new decade in 2020, it’s a time to take stock of the significant changes that transformed the pharmaceutical cold chain industry during the past decade. 

Storing Biologics At Nontraditional Temperatures

Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in nontraditional storage temperature requests. In this article, we’ll explore some of the reasons why this is occurring and the associated challenges.

Developing The Highest Purity PEGs And mPEGs For Pharmaceutical Applications

The development and manufacturing of PEGs and PEG derivatives at the highest possible levels of quality and purity is increasingly required to address the specialized requirements of pharmaceutical and biotech companies for the PEGylation of drug products. However, very few suppliers of standard or custom PEGs and mPEGs have the necessary competencies to address not only these quality and purity requirements but to overcome other technical manufacturing challenges such as the reliable handling of ethylene oxide, organic solvents, and initiators.

Rapidly Switching To Direct-To-Patient Protocols

In the midst of the COVID-19 pandemic clinical trial sponsors are having to quickly find alternative methods to keep their trials moving forward as challenges arise, such as clinical sites having to close, or patients being unable to travel to the sites for safety reasons. This article discusses the factors that need to be considered for clinical trial sponsors to incorporate direct-to-patient (DTP) protocols rapidly, to help navigate the challenges presented by the COVID-19 pandemic.

Optimizing CDMO Technical Transfer

A CDMO helps organizations predict and mediate technical transfer risks before they become costly, time-consuming problems.

More Than Just Technology: A Holistic Approach To Pharma 4.0

The transformation to Pharma 4.0 comes through small steps that are all business oriented and driven but merge together over time through a technical platform that uses data to connect people and resources.

Addressing The Evolving Needs Of Variable Drug Delivery Regimens

Pharmaceutical companies continue to advance their clinical development pipelines to develop new and more sophisticated biologics. To be successful, they will need a solution that will enable the delivery and successful commercialization of complex biologics. This article describes a device designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.

Battling Counterfeit Medicine Through Packaging Serialization

Medicines need to be packaged in a way that allows counterfeits to be quickly and easily identified, preventing their circulation and/or eliminating drug recalls. An essential element of this process is package serialization. Outsourcing work with contract manufacturers is one such way to be fully prepared for serialization implementation across all production lines.

Insight From An Expert: A Chemist’s Secrets To Efficient API Scale-Up

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Advantage Of Antibody-Based Selectivity In The Purification Of Biologics

By taking advantage of antibody-based selectivity, Camelid heavy-chain antibody fragments have proven to be a reliable immuno-affinity chromatography solution in the downstream process of biologics.

Create Brand Sustainability With Softgel Technology

Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet diverse consumer preferences and potentially extend product life cycles.

A Guide To Weigh Cell Technologies For Food And Pharma Industries

For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. The latest and greatest catchweighers and checkweighers incorporate weigh cells featuring electromagnetic force restoration, or EMFR. In addition, combining EMFR with AVC (active vibration compensation) enables accurate product weight measurements.

Tufts Study: Advantages Of Single-Source Drug Development, Manufacturing

A recent study by the Tufts Center for the Study of Drug Development (CSDD) compared cycle times and development economics between multi- and single-source CDMO models.

Ensuring The Efficacy Of Probiotic Products

There is growing interest among consumers in verifying that the dietary supplements they take are safe and efficacious. The concern over whether consumers are getting the product as it is described on the label is rooted in one vital and transformative fact: probiotics are living organisms that are highly sensitive to humidity and oxygen. In the absence of proper handling and packaging the efficacy of probiotic products can be compromised at any point of the packaging, storage, and transportation process, inversely impacting shelf life and product viability and efficacy for the consumer.

First-In-Human Trials: A Make-Or-Break Milestone For Small Biopharmas

Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into first-in-human (FIH) testing is essential. But, how?

Technical Considerations For Developing Oral Solids (Part 2)

What technical considerations should be at the forefront for your oral solids project? This two-part series features four oral solids experts from Pfizer CentreOne’s global network and partner organizations discussing the technical considerations to be aware of. In the second installment of the series, our experts consider the effects of equipment design and different tablet strategies.

Current Trends In Medical Kit Packaging

Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. 

Installation Considerations For VHP-Resistant Remote Particle Counters

This application note details key design considerations when implementing vaporized hydrogen peroxide (VHP)-resistant continuous particle counters in critical GMP-controlled cleanroom environments.

8 Key Factors When Selecting A Powered Air-Purifying Respirator System

This white paper explores eight considerations in detail and could be helpful to environmental health and safety (EHS) managers and supervisors looking to select a powered air-purifying respirator system for their particular application.

The Basics Of Biosafety Cabinets

The role of a biosafety cabinet, while critical, might seem passive. A biosafety cabinet (BSC) does not perform any one direct function, but, rather, it prevents adverse conditions from occurring.

Taking Digital Control Of Cell Therapy Logistics: An Advanced Therapy Treatment Center Network Case Study

Within the manufacturing workflow there are two critical logistics steps: 1) transport of the starting material to the manufacturing site, and 2) return of the finished product to the treatment center. In this case study we describe work to establish and test a cryogenic logistics pathway for an allogeneic advanced therapy medicinal product (ATMP).

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