Newsletter | September 22, 2021

09.22.21 -- Prefilled Syringes: X-Ray Analysis Of Closure Integrity

 
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Industry Insights
Built To Fail: 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. 

SimpliFiH Solutions For Accelerated Pharmaceutical Development

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

Impact Of A Pandemic Outbreak On Vaccine Development Approach

Several challenges with traditional vaccine development methods must be overcome in order to reduce the timeline for vaccine distribution.

Overcoming Cell Therapy Supply Chain Challenges

To ensure the industry can realize the potential of cell and gene therapies, we must develop improved solutions that reliably support the control and transport of critical cell and gene therapies (CGT) raw materials and products.

Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements And Timelines

Manufacturers must understand the challenges associated with creating a chemistry, manufacturing, and control (CMC) strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.

Leveraging The 4Cs To Deliver Bioprocessing 4.0

This blog explains the “4 Cs” of Biopharma 4.0 — the software, automation, and analytics tools that provide interconnection, information transparency, and decentralized decision-making.

L-Glutamine Dipeptide To Improve Cell Culture Performance

Depending on the cell line, clone, product, and media formulation used for biopharmaceutical production, it can be helpful to evaluate additional glutamine dipeptides to maximize performance. 

Small Biotech Recognizes CDMO's Monoclonal Antibody (mAb) Expertise, Track Record

William B. Jones, SVP of pharmaceutical development at Corvus Pharmaceuticals, discusses CDMO selection for its developing antibody program in oncology, immune disorders, and infectious diseases.

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.

RTU Components: Why You Need Them

Ready-to-use (RTU) components can simplify processing requirements for aseptic fill and finish by reducing the need for equipment, utilities, and product space.

From Research To Commercial: A Seamless Supply Of Oligonucleotides

This white paper discusses how to meet the seamless supply challenge by providing development, scale-up, and synthesis capabilities of research to commercial quantities of customized oligonucleotides.

Low-Risk Frozen Distribution Of Single-Use Bags For Bioprocessing

This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.

Scale-Up Of E. coli Fermentation From Small To Pilot Scale

In this application note, the team used E. coli fermentation to demonstrate the scale-up capabilities of Eppendorf fermentation systems from small scale to bench scale and pilot scale.

Bring Product Quality Assessment Into Early Clone Selection

Product aggregation is a major stability, efficacy, and safety concern in the manufacturing of antibody therapeutics. How do you enable detection of product aggregates within days of single-cell cloning?

How To Create Momentum In An Already Established Brand

Has your brand hit a ceiling? Which components are succeeding, and which are falling short? How understanding these dynamics impacts the larger organization’s successes and failures.

Keys To A Successful Rapid Commercial Launch

For new biologics, combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.

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

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

Regulatory Strategies For Gene Therapy Product Development

This webinar discusses the current state of regulatory issues around gene therapy product development, key challenges for manufacturing controls, and other insights in navigating the path to commercialization.

Maintaining Pharmacopeia Compliance Of Your Osmometer
Former GSK senior scientist, Aashni Shah, discusses the use of calibrators and controls in QC release testing and new software and hardware developments to aid compliance.
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