Newsletter | February 23, 2021

02.23.21 -- Cleaning Of Multipurpose API Plants: 9 Rules To Follow

 
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Quality Assurance And Your CDMO

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Advantages Of Hot Melt Extrusion To Create Amorphous Solid Dispersions

The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. 

Effectively Managing Data In Process Development

Addressing data management challenges during drug development calls for a deeper understanding of the shortcomings of today’s methods and the factors you need to consider when adopting a solution to overcome them.

A Stepwise Approach To CMC Planning For A Biologics License Application

Lonza understands the challenges of designing a chemistry, manufacturing, and controls (CMC) strategy and has developed a structured and stepwise approach to planning that is tailored to our customers’ product, process, timelines, and risk tolerances.

Convey Hazardous Powders Safely In Pharmaceutical Manufacturing

Consider these seven key parameters when selecting vacuum conveying technology.

4 Ways To Avoid Failure In Phase 3 Clinical Manufacturing

Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you will have later when the costs — and the stakes — get even higher.

Government Partnership Highlights Blow/Fill/Seal Advantages In COVID-19 Vaccines

Continued global efforts to incorporate blow/fill/seal (BFS) in the safe and efficient delivery of life-saving vaccines are proof the technology serves as a valuable tool in improving patient care across the world.

High-Throughput And Single-Use mAb Purification With Fibro Chromatography

How rapid cycling, fiber-based chromatography (Fibro) enables substantially reduced purification times in research and PD and a single-use solution for monoclonal antibody (mAb) manufacturing.

Ensuring The Efficacy Of Probiotic Products

In the absence of proper handling and packaging, the efficacy of probiotic products can be compromised at any point of the packaging, storage, or transportation process.

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. 

Direct Heat vs. Water Jacket CO2 Incubators

CO2 incubators enable the necessary environmental control and isolate cell cultures from external conditions and contamination. Which one is the best fit for your research?

Quality Management Competencies Reagent Suppliers Should Possess

Evaluating a potential reagent supply partner’s manufacturing capability requires an understanding of how that partner manages and controls their manufacturing operations to ensure your product is delivered on time and to your specifications, every time. 

Data Gathering And Analysis Necessary In New Tablet Development

A significant concern in tablet manufacturing is speed-to-market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. 

Pump Life Testing Of TPE Tubing

Tubing used in welding operations is often incompatible with peristaltic pump use. We tested pump life performance by subjecting samples to continuous pumping until failure was observed.

Recommended Mixing Equipment For Liquid Supplements

In the production of ready-to-drink supplements and liquid vitamins filled into capsules, proper mixing is one of the most critical steps in achieving lot-to-lot consistency and efficacy. 

Validated Shipping Of Filled Labtainer Pro BioProcess Containers (BPCs)

This application note details wet shipping tests performed to ensure that Labtainer Pro BioProcess Containers maintain integrity, keeping contents contained and protected. 

Streamlining Delivery Device Manufacturing

A leading European pharma company needed highly resistant glass cartridges that could be easily integrated with a pen injector used in a range of treatments. 

Best Strategies To Accelerate Biologics Development And Commercialization

How practical implementation of a modernized cell line development workflow using high-yield cell lines and automated systems accelerates biologics development and commercialization.

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