Newsletter | October 12, 2021

10.12.21 -- Biotech Patenting: 4 Tips & Personal Experiences

 
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CMO As Partner For Antibody-Drug Conjugate (ADC) Process Development, Scale-Up And Optimization

Antibody-drug conjugate (ADC) programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

Ensuring Quality Oversight In Plasmid DNA (pDNA) Manufacturing

It is important to understand the challenges associated with manufacturing pDNA, so you can ensure the partner you select is able to provide high-quality materials for the lifetime of your product.

Evaluating Current Manufacturing Platforms For Recombinant Adeno-Associated Virus (AAV) Production

Realizing the full potential of viral vector-based therapies requires an understanding of the platforms currently available for recombinant AAV production as well as how to properly evaluate them.

The Value Of Orphan Drug Designation

More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

Implementing automated technologies and robotics could be the solution 503B compounding pharmacies need to overcome growing issues with sterility and data integrity.

Strategies For Flexible Manufacturing

Custom-designed equipment and suites, flexible manufacturing lines, and alternative delivery and manufacturing approaches are critical to achieving a timely and successful launch in a competitive marketplace.

Dilution Of High Active Surfactants

High active surfactants and water are of widely differing viscosities. If surfactants are pumped into the water in the vessel, they are not easily blended by conventional agitators. This can lead to globules of surfactant remaining undiluted or being partially diluted. Dilution is best carried out using a high-shear in-line mixer.

Spray-Dry Manufacturing Formulations For Local Lung Cancer Treatment
Lung cancer accounts for 23% of all cancer-related deaths in American adults. Though several monoclonal antibody (mAb) treatments utilizing parenteral delivery have been commercialized, local delivery has been impossible. Recent advances in spray-drying technology show promising results and potentially facilitate more effective mAbs through direct delivery to the lung.
Intensified And Improved Fed-Batch Production Process: High-Density N-1 Perfusion

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

Navigating The Complexities Of An IND Submission In The Emerging Chinese Market

On October 14, Lonza Biologics will present a webinar on how to navigate the complexities of submitting a clinical trial application in China.

How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success

In the realm of sterile injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships has a huge influence on project success. Explore how a small or midsize biotech or pharma company can benefit from the experience and assistance provided by a CDMO.

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.

Micro-RNA Nanoparticles For Gene Silencing: Measuring Size And Zeta Potential With Light Scattering Technology

One of the biggest challenges of RNA interference is the difficulty to deliver intact siRNA/miRNA across the cell membrane and into the cytosol while preserving cell viability. Here we demonstrate that the Litesizer™ 500 returns rapid and precise results despite very low sample concentration and volume.

Loss Monitoring And Categorization

All manufacturing industries suffer a variety of different performance losses including production losses, product quality losses, energy losses, raw materials losses, environmental/regulatory losses, and others. These losses can negatively impact profitability, environmental stewardship, and even license to operate. A manufacturer needed a way to gain insight into the leading causes of production losses, finding those times when equipment was not running at capacity and categorizing the loss by reason. 

Find Your Dream Dose Form: Matchmaking Your Brand To The Right Innovation

To spark your thinking about the right dosage form innovation, meet five high-quality, increasingly popular technologies that may hold the key to your brand’s healthy growth and greater differentiation.

Partner Perspectives To De-Risk Commercialization Of Combination Products

Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.

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