Newsletter | July 9, 2024

07.09.24 -- Chugai's Race To Zero Emissions At UK4 In Tokyo

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If you can’t win the game, change it

The global biopharma supply chain is complex. To navigate it, we must use data in a new way—not just as standalone companies, but as a united whole. Learn how here.

INDUSTRY INSIGHTS

Environmental Monitoring Handbook For Pharmaceutical Manufacturers

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.

Enabling Complexity: Drug Substance Manufacturing Via Continuous Flow

As molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology to facilitate the integration of complex synthetic methods into API production.

Mitigate Drug Shortage Risk With Improved Collaboration

Learn how to overcome the hurdles associated with traditional data management approaches, and discover the key to reducing the risk of drug shortages in pharmaceutical manufacturing.

Solid Form Screening Of Active Pharmaceutical Ingredients

Explore the role of solid form services in helping meet accelerated timelines of the drug development lifecycle along with examples of robust workflows for fast and thorough solid form screens.

Blended Learning: An Approach To Operator Training

Are your current training methods costly and time-consuming? Explore the benefits of blended learning, which can be up to four times faster than traditional training methods.

The Importance Of A Multifaceted Approach To Containment

Risk assessment is integral to manufacturing processes, particularly in drug production, and having effective containment strategies can help identify potential hazards and ensure worker safety

Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

Leveraging CDMO Expertise To Achieve Aseptic Fill/Finish Success

Achieving high-quality drug product requires a combination of meticulous quality control measures, personnel expertise, and judicious application of technology — benefiting patients and the industry.

Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles

As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

A Guide To CRO, CMO, And CDMO Partnerships

By partnering with a reputable CDMO, biotech and pharmaceutical companies can leverage their expertise and resources to expedite the development and manufacturing of life-saving medications.

Using Zydis ODT To Solve Delivery Challenges For Tolerogenic Vaccines

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

FEATURED EDITORIAL

Chugai's Race To Zero Emissions At UK4 In Tokyo

Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

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Register by 17 July to Save up to 20%

The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP).

SOLUTIONS

Pharmaceutical Denesting Equipment For Syringes, Vials, And Cartridges

Cleanroom Classification Zone Creation For ISO 14644, Annex 1, China GMP

Simplified Sampling Solutions For Stainless Steel Equipment

How CMOs Can Meet Demands For Data In Life Sciences

Pharmaceutical Capsule Polisher

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