Newsletter | November 22, 2022

11.22.22 -- India's New Drugs Draft Bill 2022

Featured Editorial
Industry Insights
Gliding Toward De-Risked Combination Product Development

Discover how a new product’s role is critical in determining combination products’ exposure to extractables and leachables.

Late-Stage Serialization Customization: A Key Differentiator For CDMOs

CMOs and CPOs currently face significant challenges, including strong competition, high-cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.

Overcome The Challenges Of Small Batch Production While Maximizing Yield

Small batch production will serve a critical role in the future of modern medicine. Learn more about maximizing process efficiency to reduce waste and improve yield for small batches of drug product.

Maintaining Aseptic Processes Using Small-Volume, Closed Systems

As autologous cell therapies and other targeted gene therapies work to scale up to commercial levels, connections that can be changed out in seconds represent a distinct advantage for industry.

Accelerating Novel Therapies To The Market

The formulations for novel therapeutics require flexibility to support adaptive sterile manufacturing and an integrated approach for a path from development, to small batch manufacturing, to commercialization.

Is Your Biologic At Risk For Protein Aggregation? Part 2

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.

Addressing Membrane Fouling: The Value Of Zeta Potential Measurements

Understanding the role of surface charge as a function of pH in membrane fouling, and how zeta potential measurements account for it, may help scientists evaluate product performance and regeneration efficacy.

The 3 Cs You Should Expect From Your Pharma Service Provider

Learn what indicates whether a service provider has the capabilities desired by a drug sponsor to fulfill a company’s long-term goals and is committed to their success.

A Novel Purification Tool's Effects On HCP Reduction, Turbidity

This study involved a DoE approach to investigate effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze AEX Hybrid Purifier and efficiency of the Protein A capture step.

Tips For Purifying Cryo-EM Samples

Cryo-electron microscopy can help you determine structures for challenging proteins such as membrane proteins and larger complexes. This presentation offers tips on purifying your cryo-EM samples.

Selecting Tablet Tooling Guide For OSD Manufacturers

Learn how choosing the right tooling can increase tablet output, decrease waste, and ultimately determine the success of a product launch.

Precision Powder-In-Capsule Microdosing Accelerates Drug Product Development

Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

Five Steps To Packaging Quality Assurance For Liquid Pharmaceuticals

Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.

Improved Viable Particle Discrimination With Real-Time Viable Particle Counter

A new algorithm developed by the BioTrak Real-Time Viable Particle Counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.

Speed To Market: API Large-Scale Commercial Manufacturing

A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large-scale assets, multinational sites, and an exemplary quality systems/U.S. FDA track record.

From Molecule To Medicine. Delivered.

To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologic therapies throughout the development timeline.

Nasal Delivery Technology, QbD Processes, And Outsourcing

Understand the advantages of unit/bi-dose nasal delivery technology, the application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.

Q&A: Solid Form Screening And Rapid Formulation Selection

Dr. Michael Grass answers attendee questions from a recent webinar about the importance of using solid form screening and rapid formulation selection at an early stage of development.

What Factors Impact Quality For Medical Device Manufacturers?

This article asks the corporate vice president of quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

Establishing A Correctly Characterized Molecule In Early Drug Development

Understanding the relevant solid-state properties and solid-liquid equilibria of a solid active pharmaceutical ingredient (API) are central to both chemical process and product development.

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