Newsletter | October 13, 2021

10.13.21 -- Is A SPAC The Right Option For Your Biotech Or Emerging Pharma Company?

 
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Effectively Managing Data In Process Development

Addressing data management challenges during drug development requires an understanding of today’s shortcomings and the factors to consider when adopting a solution to overcome them.

Five Dangers Of An Insecure API Supply Chain

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

Downstream Process Intensification With Novel Chromatography Resins For Enhanced Monoclonal Antibody (mAb) Purification

Avantor has designed an integrated mAb downstream purification process to enable significant throughput improvement while removing critical impurities.

6 Misconceptions About Automating Cell Therapy Manufacturing

To help you move into a digitized world, here are six common misconceptions that can potentially hinder your ability to successfully execute a manufacturing execution system (MES) for cell therapy.

Addressing The Training Gap For Single-Use Technologies

This article reviews how a blended training approach of face-to-face, e-learning, virtual classrooms, virtual, and mixed reality training is the best way to achieve training goals.

Three Ways To Successfully Scale Up Your Bioprocessing Production

Here are four important steps R&D scientists, production engineers, and other bioprocessing specialists can take to facilitate a smoother and more efficient tech transfer.

Using A CMO To Streamline Process Characterization

While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

Conversion Of A Viral Glycoprotein Titer Method From ELISA To BLI

In this case study, the analytical development group was provided an ELISA titer method, and the method was redeveloped to operate by biolayer interferometry (BLI) using the ForteBio Octet RED96.

The 5 Pitfalls Of API Development

No matter where you are in the API development life cycle, early planning makes a big difference. Every plan should keep these five key milestones — and potential pitfalls — in mind.

Are You Prepared To Move A Bioconjugate Candidate From Clinic To Market?

Despite the potential of ADCs and other bioconjugates, they present a wide range of challenges for drug manufacturers trying to navigate their way to commercial success.

Five Ways To Get To IND/IMPD Faster

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Expert considerations for accelerating and optimizing your early development process.

Considerations For Post-Approval Biologics Manufacturing

Read about considerations before, during, and after clinical trials that can help you maintain the biologics drug approval status you have spent years working to achieve.

Accelerating Success In Cell And Gene Therapy Development, Manufacturing

A process information system implemented early in the product life cycle is critical to cell and gene therapy development, commercialization, and wide-scale adoption. Here’s why.

Virus Retention Performance Under A Range Of Processing Conditions

Virus filtration is a critical operation in many biologics production processes and a key component of most viral safety strategies. 

Improve Scalability, Flexibility: Individualized Manifold Assemblies

How a CMO overcame an automated filling challenge when none of the single-use manifold assemblies matched its requirements. 

Safely Transporting Medicines To Patients

Do pharma companies underestimate supply chain challenges? Much can go wrong when sending a therapy from A to B, but the right collaborations can mitigate risk.

Lipid Nanoparticle Delivery Tech: Beyond mRNA Vaccines

What applications are being explored for lipid nanoparticle delivery technologies? Dr. Jay Natarajan, director of R&D, competence center for LNP technology, answers questions here.

Predicting Viral Clearance: Utilizing A Noninfectious MVM Surrogate

The use of an accurate, economical and quantifiable noninfectious viral surrogate enables downstream purification scientists to study viral clearance throughout process development.

Cell Line Development Facts And Figures

This infographic provides facts and figures regarding the global cell line development service market, approved biopharmaceutical active ingredients, and the cost of GMP certification.

The GPEx Suite Of Technologies For Cell Line Development

Biopharma products in development continue to increase in complexity, which poses a challenge for pharmaceutical companies looking to improve speed and efficiency of biologic development.

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