Newsletter | June 16, 2021

06.16.21 -- A Maverick Gene Therapy Manufacturing Strategy

 
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Fermentation: Comparative Statistics Enhance Process Productivity

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.

Overcoming Cell Therapy Supply Chain Challenges

To realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Improving End Results In Phase 2 Through Media Optimization

Challenges in drug development today call for manufacturers to identify not only what new capabilities and resources they need to get ahead but also how to optimize current processes to fuel growth. 

Standardization And Control: Protecting People, Product, And Reputation

A bioprocessing system that allows manufacturers to apply predefined recipes for sterile filtration and/or dispensing removes the variability and potential for human error that is inherent in manual processes.

Global Single-Use Supply Chains: Managing Risk, Minimizing Complexity

Biopharma manufacturers can benefit by adopting a global single-use supply chain strategy early in the drug development life cycle and carefully evaluating their single-use equipment and materials suppliers.

Shaping Biopharma's Future: Next-Gen Contract Drug Manufacturing

With the biopharmaceutical industry undergoing significant transformation, it is essential that CDMOs evolve to meet the intricate, dynamic needs of their clients.

Vial To Prefilled Syringe: Formulation Dev's Affect On Manufacturing

Understanding how formulation development for a prefilled syringe affects manufacturing can drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Model-Based Real-Time Concentration Modeling In Protein Chromatography

Learn how osmolality as an at-line method is an excellent predictor, together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.

Speed-To-Market: The Optimal Program For Your Candidate

With a variety of gene to IND programs on the market, it is important you carefully assess which program matches your technical expectations as well as your risk adversity profile.

What The Proposal Process Reveals About A CDMO Partner

The way a CDMO responds to a request for proposal provides significant insight into how the CDMO will approach a long-term collaboration.

Evaluating Container Closure Integrity Of High-Risk Pharmaceuticals

Manufacturing inconsistencies and tolerance differences often result in container closure failure, causing serious implications down the supply chain. 

10 Questions Investors Ask — And How To Respond To Them

Investment veterans and biopharma executives were asked which questions they often ask. Answer them well, and your potential investors are that much more likely to support your company’s vision.

Addressing The Evolving Information And Automation Needs Of Biopharma

A dramatic increase in the information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

The Criticality Of API CDMO Selection: Insights From A Client

Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them.

QbD And Process Analytical Technology (PAT) In Biopharma Development

Industry experts weigh in on process validation, QbD/PAT, sending technology, and multivariate data analysis in this information e-book.

Using A Minute Virus Of Mice Surrogate During Downstream Development

Regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. Here, a noninfectious MVM-MVP was used as an economical spiking surrogate. 

Making Agile, Data-Driven Decisions For Biopharmaceutical Organizations

Obstacles regularly faced by biopharmaceutical organizations and a solution to overcome them.

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