Newsletter | September 9, 2021

09.09.21 -- How To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins

 
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Industry Insights
Using Softgel Innovations To Grow Market Share

Softgel capsules are one example of a highly versatile dose form that consumers choose because the product provides a pleasant, convenient, and effective experience. 

This Antibody-Drug Conjugate (ADC) Stands Out In The Crowd Of HER2-Targeted Conjugates

By virtue of its manufacturability, ease of analytics, and critical ability to deliver efficacy coupled with good tolerability, the SMARTag platform and Catalent’s HER2 ADC stand out in the crowd.

Understanding Multinational Regulatory Filings: New Chemical Entity

Finding the right CDMO for the development and commercial launch of a new chemical entity presents sponsors with a challenging scenario that is magnified when a multinational launch is planned.

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

Nanoparticle Engineering: Revolutionizing Oral Drug Delivery

Nanoparticle engineering — the process of shrinking down the size of drug particles — has emerged as a promising solution to enhance drug solubility and bioavailability.

Performance Of Novapure Plungers For Syringes In Autoinjector Systems

When moving from vial systems to prefilled syringes and autoinjector systems, factors to consider include patient and caregiver needs, drug product requirements, system components, and performance.

Illustrating A Successful Small Biotech-CDMO Relationship
In this article, Levicept’s founder and CEO discusses his experience in selecting and working with a global CDMO partner, and the value Lonza brought to his virtual company.
Technical Considerations For Developing Oral Solids (Part 1)

Navigating an oral solids project can be a challenging path. This article looks at the importance of technical groundwork and understanding excipients in the early stages of the project.

10 Reasons Formulation Complexity Is On The Rise In Steriles

Complexity is rising in sterile injectables, driven by factors that include formulation and delivery. Reduce complexity and save time on the way to IND authorization and first-in-human trials.

Evaluating Container Closure Integrity Of High-Risk Pharmaceuticals

Since many high-risk pharmaceutical products are filled and sealed in combination devices, it’s critical for manufacturers to ensure that the components function well together. It is critical to use the most precise leak testing method possible.

The Challenges Of Biopharmaceutical Quality

More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

A novel drug’s path to market is complex and uncertain. Drug developers must successfully navigate the journey, under the growing pressure of regulation and competition, while carefully managing technical and financial risk.

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