Newsletter | October 6, 2021

10.06.21 -- FDA's Controversial Final Rule On Intended Use For Drugs & Devices

Featured Editorial
Industry Insights
3 Key Considerations When Choosing A Partner For Your Tech Transfer

One way to streamline tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum.

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

Get insights on how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.

Navigating Chemistry, Manufacturing, And Controls (CMC) Requirements For Accelerated Development

CMC activities are critical to quickly and efficiently move promising new drug products to market. Careful planning and early integration of an effective CMC strategy contributes to project success.

Transportation Solutions For Cell And Gene Therapy Supply Chains

Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

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.

Key Productivity, Scalability Considerations

COVID-19 caused biopharma innovators, CDMOs, data management firms, and raw material suppliers to collaborate at a level never seen before. How do we maintain that collaborative spirit under duress?

Best Practices For Oncolytic Virus Design, Development, Manufacturing

Oncolytic viruses have the potential to revolutionize standard cancer treatment, but their continued progress hinges on meeting a number of goals linked to safety, efficacy, and commercial scale-up.

Drug Repurposing Advantages And Strategies

Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.

Enabling Perfusion Processes With Cell Retention Technologies

In this white paper, we explore various strategies for the intensification of upstream perfusion processes with cell retention technologies and the viability of each solution.

Intensified, Improved Fed-Batch Production Process

The method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.

Overcome The Challenges Of Biologics Finished Product Manufacturing

The main challenges associated with the first clinical supplies of an aseptic drug product fall into one of three categories: formulation, fill/finish, or post-production.

Virus-Based Vaccine Bioprocessing Handbook

The manufacturing process for each viral vaccine is dictated by shape, size, nature, physicochemical behavior, stability, and host specificity. This paper reviews steps in these manufacturing processes.

Evaluating Stability Of Biosimilar Monoclonal Antibodies (mAbs) With Microflow Imaging

Here we show how we use microflow imaging (MFI) to evaluate the stability of two therapeutic monoclonal antibodies, trastuzumab and bevacizumab, and their biosimilars.

Highly Sensitive Charge Variant Analysis Of Complex Biopharmaceuticals

Explore the use of a capillary electrophoresis device to perform highly selective charge variant separation of complex pharmaceuticals for native intact antibodies while generating excellent quality MS data. 

Navigating The Full Biologics Drug Development Life Cycle

This Q&A addresses attendee questions from a recent webinar about a new biomanufacturing site in Waltham, MA, equipped with state-of-the-art equipment.

Best Practices For Tech Transfer Success

Ensuring project success, including project management tools, people, network capabilities, process improvement, and culture, and addressing challenges and risks faced during technology transfers.

Oligonucleotide Therapeutics: Bridging From Research To Commercial

Hideyuki Tanaka, senior director at Ajinomoto Bio-Pharma Services, examines the necessary development and manufacturing expertise required to seamlessly transition from research to commercial.

Improve Quality And Yield For Viral Vector Manufacturing
Osmolality has long been considered a critical measurement in biopharma, describing how much of a solute is present in a given solution. It's increasingly applicable in cell and gene therapies.
Tech Transfer In Sterile Injectables: 3 Phases Of Success
Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.
Powder-In-Capsule Microdosing Accelerates Drug Development

Precision powder microdosing in capsules makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

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