Newsletter | January 9, 2023

01.09.23 -- Who's Afraid Of Their CDMO Getting Acquired?
 
New Podcast Episode
From The Editor
Who's Afraid Of Their CDMO Getting Acquired?
 
By Louis Garguilo, Chief Editor, Outsourced Pharma

“It seems as soon as a new boutique or smaller CDMO – especially in the biologic space – can get established, one of the big guys is eating them up,” says Kelly Creighton, Citrus Pharmaceuticals. In this hard-hitting editorial, Creighton provides readers with some positive thoughts and solutions to overcome the challenges M&A may bring.
The Analytical Services Outsourcing Bottleneck
By Outsourced Pharma Live

Steven Goodman of Vertex details challenges in outsourcing analytical services in the cell and gene therapy space. In October 2022, Outsourced Pharma Live's “What’s Driving The Cell & Gene Therapy Outsourcing Capacity Cycle?” panelists discussed the identified macro and micro trends impacting deal-making at CDMOs. Exclusive data from BioPlan Associates was also presented. Learn what to be on the lookout for as well as how to prepare and take advantage of (another) "life cycle" in our industry — this time in the cell and gene therapy space.
Featured Editorial
Make The Service Agreement Work For You And Your CDMO
 
By Mauro Turrini, Jean-Christophe Troussel, Nadia Feola, and Auriane Schockaert

Knowledge of the applicable rules and legal challenges, as well as ways to ensure the enforcement of proprietary rights, requires companies to invest in negotiating and drafting robust and balanced CDMO service agreements. This article provides practical tips (for both the principal and the CDMO) for drafting these vital legal agreements.
The Regulatory Labyrinth Of Stem Cell Treatments
By Chad Landmon and Gulrukh Haroon, Axinn

In August, Judge Bernal of the Central District of California ruled that stem cells that are removed from a patient, centrifuged, and reinjected into a patient are not “drugs” and therefore do not require FDA premarket approval. The FDA filed a notice of appeal in October, but the appeals process will take time. Until then, the decision may have consequences for stem cell therapy companies.
Industry Insights
How A Sample/Dispense Service Streamlines Drug Development
Article | By Alice Levis, Singota Solutions

Biopharma organizations often require aliquoting of materials to support their projects, but can be burdened by the timelines, costs, and risk of compromising materials.
Align CMC Strategy With Clinical Path Requirements And Timelines
Article | By Lee Allen and Megan Mason, Lonza

Manufacturers must understand the challenges associated with creating a CMC strategy, and the expertise and resources needed to execute it, in today’s crowded and diverse market.
The Digitalization Of Biopharma Process Development, Manufacturing
White Paper | By Wolfram Schulze, Rentschler Biopharma

The fourth industrial revolution is coming. Explore the three essentials of bioprocess development and manufacturing digitalization: digital literacy, digital trust, and prioritization.
Addressing The Challenge Of Scalability In Viral Vectors
White Paper | By Henry George and Lisa Freeman-Cook, MilliporeSigma

Learn more about a wide range of solutions to facilitate the delivery of gene therapy by addressing the challenges related to viral vector manufacture and scale-up.
How To Secure A Sustainable Supply Of Raw Materials
Article | Pfizer CentreOne

How can pharma companies secure the supply of vital APIs and intermediates and maintain consistent manufacturing costs? These steps minimize supply chain insecurity in a rapidly changing market.
Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations
Article | Lonza

Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden and improving care. Explore case studies illustrating the potential for improving care for critically ill patients.
Forecasting The Integrity Of The Biopharma Supply Chain
Article | Cytiva

Receiving customer forecasts as early and completely as possible is critical to the success of the supply chain continuum.
Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform
Article | West Pharmaceutical Services, Inc.

Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
Placing Drug Strategies On A Solid Foundation For Success
White Paper | Pfizer CentreOne

Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities
Application Note | Cytiva

Many antibody variants are prone to aggregation or to forming product-related impurities. Explore the application of a resin with novel selectivity to purify challenging entities.
Investing In Capacity: API Commercial Manufacturing
Case Study | Cambrex

A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.
Cell Therapy: What Does It Take To Become A Mainstream Option?
Q&A | Resilience US, Inc.

While cell therapies still comprise a small segment of therapeutics, the landscape is rapidly changing. Explore the main biomanufacturing bottlenecks and how to overcome them.
The Journey Into Cell And Gene Therapy
Podcast | Catalent

Hear about our venture into the development and manufacturing of viral vector gene therapies and how we are overcoming challenges and maintaining our commitment to our partners.
Solutions
Process Development
AGC Biologics
Cellvento® 4HEK Medium: For Producing High AAV Titers In Multiple HEK293 Cell Lines
MilliporeSigma
CPC AseptiQuik G Assembly
CPC
Data Management
inSeption Group
Outsourced Pharma Live
 

Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.