Newsletter | January 30, 2024

01.30.24 -- A Brief Introduction To Environmental Monitoring For Startups

SPONSOR

Webinar: Planning For Success — Key Considerations When Developing Your Combination Product

Learn how to build a clear and comprehensive road map to succeed in combination product development, including how to recognize the potential risk factors and implement mitigation strategies for streamlined success. Click here to learn more.

FEATURED EDITORIAL

A Brief Introduction To Environmental Monitoring For Startups

Environmental monitoring is crucial as it indicates that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

INDUSTRY INSIGHTS

Achieve Manufacturing Scale For Your Viral Vector Production

Take your viral vector production to a commercial scale with the right production system and single-use bioreactor combination.

Selecting Container Closure Components: A Data-Driven Approach To CCI

Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.

Fluid Bed And Melt Granulation In Pharmaceutical Manufacturing

Fluid bed and melt granulation represent an opportunity for drug developers to achieve appreciable efficiency gains in their processes, as well as measurable improvements in their final drug products.

The Future Starts Today: Developing Better LNP-Based Genetic Medicines

Find out how you can accelerate the time to patients for new vaccines and therapies with innovative, streamlined technology that is quicker and more intuitive.

Transitioning From Research To Drug Formulation And Development

The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.

Gas Ingress Methods As Replacement Of Blue Dye Ingress Testing For CCI

Learn about the headspace gas ingress testing approach, which is increasingly being implemented to replace blue dye ingress as a general CCI test method.

Approaching IND: What To Consider In Early Development

When preparing for IND submission, developers must consider multiple components. Explore tips for optimizing your early development program and the benefits of housing all activities under one roof.

Revolutionizing Healthcare Access With A Resilient Supply Chain Network

Delivering supplies and biospecimens to remote areas demands an experienced logistics partner. Learn how state-of-the-art technology streamlined the supply chain process for a remote clinical trial.

Vibration Isolation For Enclosures

In analytical environments, precise weighing takes place inside containment where powders do not escape. Here, we measure the effectiveness of three vibration isolation strategies.

Early Development Considerations For Late-Stage NCE Success: Part Two

Discover how strategic partnerships, robust process development, and a keen awareness of supply chain vulnerabilities can pave the way to a successful clinical trial.

Optimizing Autologous Cell Therapy Clinical Trials

Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.

Managing Supply For Complex Biotherapeutics

The antibody-drug conjugate manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill/finish.

How Distributed Automation And DPM Support Resilient Biomanufacturing

Learn how embracing digital transformation through the use of distributed automation and digital plant maturity can support productivity, efficiency, and resilience in biomanufacturing.

Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities

How do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities?

Using Zydis ODT To Solve Delivery Challenges For Tolerogenic Vaccines

Explore the advantages offered by the freeze-dried Zydis ODT relating to large molecule storage, aggregation, and in some cases, protease activity.

SOLUTIONS

A Fully Integrated Toolbox For Therapeutic Protein Expression

Polymer Processing Capabilities

EVENTS

Aseptic Filling: Reducing Risk And Improving Sterility In GMP Manufacturing

Wednesday, January 31, 2024 | 4:00 p.m. GMT / 11:00 a.m. EST / 8:00 a.m. PST | One Hour  
Join us for an exclusive online joint webinar hosted by Cytiva and Singota Solutions. Connect with industry leaders on Wednesday, January 31, 2024, at 4:00 p.m. GMT / 11:00 a.m. EST / 8:00 a.m. PST for an immersive experience, as we dive deep into Cytiva’s expertise and Singota's top-tier aseptic filling capabilities, and gain insights into reducing risk and improving sterility. Don't miss out on this can't-miss event led by bio and pharma experts. Mark your calendar for a transformative learning experience! Register now.

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