Newsletter | June 10, 2021

06.10.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare

 
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SimpliFiH Solutions For Accelerated Pharmaceutical Development

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

How To Address Challenges In Oncology Drug Containment

Drug product containment systems comprising Daikyo Crystal Zenith cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance. 

Overcome The Challenges Of Small Batch Production While Maximizing Yield

A minimal amount of available API poses major challenges when filling a product, making process efficiency a critical factor in reducing waste and improving the yield for small batches of drug product.

An Executive’s Checklist For CDMO Selection

C-level executives must take an early and active role in vetting potential partners using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.

Providing Sterility Assurance Between Single-Use And Stainless Systems

As numerous biopharmaceutical manufacturers have gained firsthand experience with the benefits of incorporating single-use systems into their facilities, they are looking to expand use in both up-stream and down-stream applications. This is no surprise, as increased volume and diversity of pharmaceutical products is causing manufacturers to design their facilities based on shorter production runs with multiple changeovers. Meeting these demands requires operational flexibility.

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharma tech transfer, critical to successful development, manufacturing, and commercialization, requires careful planning and evaluation to meet scale-up and GMP time lines.

Are You Prepared For The Complexity Of Pediatric Drug Development?

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.

Ten Top Tips For Replacing Your Existing Electronic Lab Notebook (ELN)

Is your legacy ELN holding you back? And are you ready to take your lab to the next level? In this tip sheet, we outline ten things you need to consider when making the decision to replace your old lab technology.

Keeping It Cool: Protecting Cryopreserved Biological Samples From Degradation

Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze-thaw.

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.

Formulation Development: Determining Oxygen Sensitivity

Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen sensitivity, leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf-life stability.

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Thursday, June 24, 2021
11:00 a.m. Eastern Daylight Time

 

During this webinar, learn more about ways to optimize your manufacturing processes, increase facility flexibility, and reduce time-to-market while still delivering the highest quality products.

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