03.31.21 -- Outsourcing Challenges For Emerging mRNA Biopharma
 
Sponsor
From The Editor
Outsourcing Challenges For Emerging mRNA Biopharma
By Louis Garguilo, Chief Editor, Outsourced Pharma

Recent mRNA vaccine successes conceal the challenges emerging mRNA companies have faced with finding experience and capacity at CDMOs. Here’s sound advice for emerging mRNA companies when forming scientific, investment, and overall plans for commercial success.
Featured Editorial
A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs
By Amol Galande, Ajay Pazhayattil, and Sanjay Sharma

Regulators, including the FDA, expect that manufacturers of APIs and drug products take reasonable steps to prevent higher levels or eliminate N-nitrosamines. This article provides a checklist with some factors for a structured initial risk assessment of small molecule oral drug products.
For Supply Chain Professionals
Best Practices: Establishing Data Visibility Across Sponsor/CMO Networks
Webinar/Webcast | Skyland Analytics

Learn how you can establish reasonable expectations for data transparency and sharing in CMO relationships to ensure effective data management across the supply chain.
Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand
Guest Article/Blog | AbbVie

Today’s biologics pipeline is healthy, but forecasts indicate growth so robust the industry risks being ill-equipped to meet demand. Will contract manufacturers rise to the demand challenge?
8 Criteria For A More Successful API Partnership
Infographic | Patheon - API

Save time and money by addressing these eight critical areas that are required for a fast, smooth API development process.
Industry Insights
Are You Prepared For The Complexity Of Pediatric Drug Development?
Article | Thermo Fisher Scientific

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.
CRO/CDMO Customer (Dis)Satisfaction During COVID-19: Who Is Looking For New Partners And Why?
Article | August Bioservices

We conducted a blind, independent “voice of the customer” survey to ascertain what impact COVID-19 had and was continuing to have on outsourcing decisions for those seeking CRO, CDMO, or both services.
Sponsor
Solutions
Kindeva Hollow Microstructured Transdermal System
Kindeva Drug Delivery
Singota Solutions – Your CDMO Focused On Faster
Singota Solutions
Zydis Fast Dissolve Technologies: Effective Dose Forms For Pediatric Health
Catalent
Your Trusted Packaging And Serialization Partner
Ropack Pharma Solutions
e-book
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.