Newsletter | April 5, 2021

04.05.21 -- Applying QbD To Incorporate Excipients Into Drug Lifecycle Management

 
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Understanding Multinational Regulatory Filings: New Chemical Entity

Every regulatory agency in the world might look at a sponsor’s filing a little differently. An adept CDMO partner can anticipate challenges based on its experiences and prepare sponsors for, or help them avoid, issues that may arise.

Complex Molecule Development: Early Considerations To Avoid Failing Later

How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

CMOs As Partners For ADC Process Development, Scale-Up, Optimization

Antibody-drug conjugate (ADC) programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

A Guide To The Cell Line Development Journey

When determining a cell line, a principal concern is whether the platform will express the desired protein in a quantity substantial enough to support preclinical work, clinical work, and commercial manufacturing. Understand practices for deciding between microbial, mammalian, and yeast platforms and clearing technical and regulatory barriers.

Outsourcing Motivations Should Guide One’s Outsourcing Approach

Outsourcing motivations are important considerations to identify the best outsourcing approach and should influence the type of relationships your organization develops with CMOs. 

Successful Techniques For Progressing Biotherapeutic Candidates From Late Discovery To The Clinic

The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1,000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell lines or processes. In our latest white paper, we help you to prepare for a successful transition to bring your drug candidate from discovery to the clinic.

End-To-End Thinking During Drug Product Development

In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

Meeting The Process Development Challenges Of A Diverse Biologics Pipeline

The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring drugs reach patients safely and efficiently.  

Using Spray Drying To Manufacture Formulations For Local Lung Cancer Treatment

On April 8, 2021, join Lonza Pharma & Biotech as they discuss how spray drying can be used to address many of the challenges associated with today’s late-stage lung cancer treatments.

Process Development: Ensuring A Consistent, High-Quality Biologics

Understand risk mitigation, differences between innovator and biosimilar process development, and what to expect from development and manufacturing partners during drug product process development.

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Trending: New CDMO Models For Your Consideration (Part 1)
 

Something positive and of great importance also flowed through 2020: a handful of new and expanding business and service models at contract development and manufacturing organizations. CDMOs are changing and providing drug sponsors — particularly virtual and small to midsize organizations — with more, and, it seems, improving, options.