Newsletter | November 22, 2021

11.22.21 -- Inflation Sticks, Supply Chains Stall, Outsourcing A Struggle

 
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From The Editor
Featured Editorial
Industry Insights
Selecting A CMO Partner For Sterile Injectable Manufacturing
Performing the transfer of a product or technology from a small-scale development process to full-scale commercial manufacturing can be difficult; but vetting for the right contract manufacturing organization (CMO) partner can pose its own unique challenges.
Is Your API Ready For Scale-Up? What To Demand From Your CDMO

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Do Small Outsourcing Partners Benefit Small And Emerging Biotechs?

Large CRO partners tout expertise or experience based on past success. Pulling back the curtain on this “corporate memory” can reveal the inefficiency of “that’s the way it’s always been done” thinking.

Debunking Myths And Misconceptions About Softgels

Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.

Local Treatment Of Non-Small Cell Lung Cancer With A Spray-Dried Bevacizumab Formulation

Local delivery of biotherapeutics to the lung holds great promise for the treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

How To Avoid High Potency API (HPAPI) Contamination

To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs. In this paper learn how to determine exposure potential and select the correct equipment and technology.

Facing The Challenges Of The COVID-19 Pandemic

In alignment with health authorities and a business continuity plan, comprehensive companywide measures ensured ongoing operations and supply continuity throughout the changing situation.

Must-Use Strategies To Successfully Transfer And Scale Your Pharmaceutical Product

Finding the best commercial partner for your program starts with obtaining mission-critical technical capabilities. The best place to begin a serious conversation about the firm’s true potential to provide that value should start with a dialogue about the technology transfer process.

The Biotech And The CDMO: The Case For An Early Partnership

Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner whose broad knowledge base and experience complements your specialized expertise. Whom you partner with, and when, can make all the difference down the road.

Liposomal And Nanoparticle Technology At Pfizer Melbourne

In recent years, liposome technologies have become an important part of the drug delivery armory, with several marketed products now available for use and many more formulations being evaluated in clinical trials.

Solutions For Challenging Compounds Using Softgel Innovation

The significant interest in semi-solid systems for the potential of extended-release profiles has prompted researchers to develop alternative encapsulating systems. 

Pressurized Meter Dose Inhaler Plume Characterizations

Dr. Ben Myatt discusses pressurized meter dose inhaler plume characterizations, specifically around alternative propellants temperature and pressure measurements.

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CEOs And The Complexities Of Outsourcing
 

Decisions on the strategies and implementation of drug development and manufacturing outsourcing have never been so important to the overall health and direction of both emerging and established biopharma organizations. CEOs today need to take on a higher degree of leadership in making these decisions. To outsource or not, how much, where, and when, have become existential questions of survival, and keys to success (or failure). Chief editor Louis Garguilo investigates how the C-suite can navigate the complexities involved.