Newsletter | September 21, 2021

09.21.21 -- What's The Role Of Interim Consultants In The Life Sciences And How Do We Use Them Effectively?

 
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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.

Project Management To Meet Today’s Drug Development Challenges

Gain insights into the steps CDMOs can take to streamline project management to benefit the small and emerging biotech companies they work with.

Ultra-Low Temperature Freezers: A Guide To Proper Use And Preventive Maintenance

The following criteria will help a lab manager train users and maintenance staff on protocols to keep the ultra-low temperature (ULT) freezer running optimally and reliably for cell preservation.

The Value Of Agile Project Management In Pharma’s Race To Market

As regulatory policies for new drug development tighten and competition grows fierce, manufacturers must identify organizational strategies that can increase their flexibility so that they can keep pace with today’s market.

Comparing Methods For Residual Moisture Analysis Of Lyophilized Products

Many biopharmaceuticals rely on freeze drying to extend the shelf life of these valuable materials. The residual moisture content after freeze drying is a critical product parameter that should be optimized per product formulation and, ideally, a residual moisture determination method should be available for these activities that enables efficient analysis of statistical sample sets. This article explores the different analysis techniques can be used to determine the residual moisture levels of freeze-dried product.

For Monoclonal Antibodies (mAbs) A Small Biotech Recognizes The Value In Lonza’s Expertise And Track Record

William B. Jones, senior vice president of pharmaceutical development at Corvus Pharmaceuticals, discusses his company’s selection of a CDMO for its CPI-006 antibody program, which is currently under development as an oncology drug and investigation as a therapeutic for immune disorders and infectious diseases.

How Does Media Selection Impact Performance Testing Of Poorly Soluble Drugs?

On September 29, Lonza Biologics will present a webinar on the design of dissolution media to support biopredictive dissolution testing, which enables the development of bioavailability-enhancing formulations for poorly soluble drugs.

The Key To Success When It Comes To Selecting The Container Closure System For A New Drug

Choosing the most appropriate container closure system is one of the most fundamental considerations in the development of a new injectable drug. The correct selection can save significant time and resources during the development process and help to smooth the path to eventual regulatory approval.

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. 

Serialization And Aggregation Requirements In Russia

Russian president Vladimir Putin signed Federal Law No. 488-FZ, which deals with amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation.” 

Control Strategy: What, When, Where, And Why For Drug-Device Combination Products

Building a control strategy starts with understanding the product and process and comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters.

Developing A Closed Connected Single-Use Monoclonal Antibody (mAb) Purification Process

This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

Global Biopharma Improves Product Purity And Reduces Costs With Biovia Discoverant

Following several mergers and acquisitions, a biopharmaceutical company had to manage an increasing amount of data from disparate online and offline sources. As these data spanned long timeframes, it was very resource-intensive (time, people, and money) to establish the relevant time window. A solution that allowed them to access data from online and offline sources and to feed other systems with data quickly became their analytics tool for extracting and contextualizing data in support of the company’s digital science and manufacturing informatics strategies.

Better Therapeutic Outcomes From Better Drug Delivery

Innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules can meet the goals of patient-centric therapies, improved medicine, and better healthcare economics.

Small Pharma, Big Opportunity: 8 Reasons To Look Beyond Size

Should CDMO partner size influence selection for your large molecule project? To choose the best CDMO for you, here are a few reminders to help you look beyond size.

Benefits Of 5KL Bioreactor In Late-Phase Biologic Substance Manufacturing

Watch this webinar today to discover how Thermo Fisher Scientific is addressing and overcoming two critical, current challenges in upstream bioprocessing.

Overcoming Difficult Cleaning Residues In Life Sciences

Introduction and general cleaning concepts including detergent selections and chemistry in life sciences, COVID-19, cannabis cleaning, RNA and DNA cleaning, and more.

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