Newsletter | June 22, 2022

06.22.22 -- We Need More University-Based CDMOs

 
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From The Editor
Featured Editorial
Industry Insights
Patient-Centric Dosage Forms: A Viable Solution To Non-Adherence

Better adherence can often result by considering therapy- and patient-related factors during the design and development of patient-centric dosage forms.

Achieving Large-Scale Ophthalmic Production

Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

How To Mitigate Cell And Gene Therapy Manufacturing Risks Amplified By The COVID-19 Pandemic

Understanding not only the limitations of a post-COVID-19 manufacturing landscape, but also developing strategies to help overcome these challenges, is critical to drive the future of next-generation CGTs.

Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer

Development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

How Collaboration Transformed A Generic Into A Best-In-Class New Drug

Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial sterile injectable approved by regulators.

Considerations For Your First Clinical Trial

For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming, and clinical research organizations (CROs) do not typically manage the comprehensive clinical trial supply chain. Discover seven best practices to help ensure a successful trial.

Cleanliness Is Next To Godliness In The Manufacture Of Medicinal Products

Cleanrooms are used extensively in the pharmaceutical, biotech, medical device, and life sciences industries to reduce particulate contamination and to control other environmental parameters, including temperature, humidity, and pressure.

Rapid Change Is Everywhere In The Biotech Industry. Meaningful Innovation Is Not.

CDMOs face the challenge of integrating novel technologies to deliver cost-effective innovation to the market. How a CDMO responds to the unexpected can determine the success or failure of a project.

Ensuring Resilience: How Life Sciences Is Reshaping Supply Chains In Response To COVID-19

Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.

Patient-Centric Approach And FDA Expertise Lead To Orphan Approval

An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. Find out how this was done in the available case study.

Nasal Delivery Technology, QbD Processes, And Outsourcing

Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.

Strategies To Mitigate Common Pitfalls In Early Drug Development

Two experts discuss the ways companies can address issues with low bioavailability and the benefits of enlisting an experienced drug development partner.

Solid Form Screening And Rapid Formulation Selection To Meet Demands Of Accelerated Timelines

See how experience, targeted testing, and basic scientific principles can quickly lead to the selection of effective and commercially viable formulations at an early stage of the development cycle.

Large-Scale LVV Production: Process Development To GMP Vector

Explore the key advantages of a proven approach to scale the lentiviral vector (LVV) production process (48L cf) in a bioreactor (200 L) without changing critical quality attributes (CQAs).

Accelerate The Development And Production Of Viral-Based Gene Therapies

The recent pandemic revealed that with the proper framework a drug product can be developed, clinically tested, and produced for hundreds of millions of patients in less than a year. 

Benefits Of 5KL Bioreactor In Late-Phase Biologic Substance Manufacturing

Watch this webinar today to discover how Thermo Fisher Scientific is addressing and overcoming two critical current challenges in upstream bioprocessing.

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