Newsletter | January 10, 2025

01.10.25 -- Zero-Acceptance Sampling Can Protect Your Next Data Migration

SPONSOR

Webinar: Quantifying and Assessing Cleaning & Disinfection Residues: A Case Study

This presentation reviews the impact of cleaning and disinfectant residues in ATMP cGMP manufacturing, focusing on their risks and management. It addresses how Annex 1 revisions highlight the need for better residue control, offers methods to quantify residues beyond visual inspection, and discusses designing effective cleaning regimes. Click here to learn more.

INDUSTRY INSIGHTS

Containment Liability: Choosing Assurance Or Insurance

Engineering controls designed to mitigate exposure and create separation between the operator and toxic material are available in many forms, all with their own unique advantages and risks.

How To Navigate The EU HTA Regulation For Better Market Access

The EU's new Health Technology Assessment Regulation poses challenges and opportunities for the industry, making manufacturers adapt to unpredictable PICOs and prioritize scenario planning.

Delving Into Modular Cleanroom Designs For Drug Manufacturing

Explore the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

The Problem With Construction Quality

Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

Cold Chain Distribution: Commercial Considerations

The increased volume, added complexity, and logistical challenges that define cold chain shipping require companies to carefully consider the thermal packaging solutions that best serve their needs.

The ROI Of Pharma MES: How Investing In cGMP Compliance Saves Money

Transform your pharmaceutical manufacturing processes and enhance compliance by implementing a modern pharma manufacturing execution system (MES).

How To Select The Right CDMO For Your Tech Transfer

Selecting the right CDMO to properly execute your tech transfer is critical for ensuring optimal process reproducibility that preserves the intended quality, efficacy, and safety of a drug product.

Optimizing The Path To First-In-Human Clinical Trials: Design And De-Risk

Explore the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Advanced Isolator Tech Boosts Manufacturing Efficiency And Quality

Isolator technology can run continuously over several days, minimizing operator interaction and other opportunities to introduce contamination — ideal for high-volume, time-limited production runs.

Finding An Optimal Harvest Solution By Considering Cost And Sustainability

Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Discover the benefits of a single-use centrifuge over traditional depth filtration methods.

Removing The Headache: Outsourced Stability Storage And Testing Solutions

Darryl Souness, Head of Analytical at Cambrex Edinburgh, and Stephen Delaney, Managing Director at Q1 Scientific (a Cambrex Company), share insights on the benefits of outsourcing stability storage and testing.

FEATURED EDITORIAL

Zero-Acceptance Sampling Can Protect Your Next Data Migration

When migrating data in a GMP setting, verifying every record is impossible. A well-structured sampling approach can mitigate the risks and help with a smooth transition.

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The peptide market is booming, driving manufacturers to enhance processes and capacity. What key changes are shaping peptide manufacturing? How can continuous manufacturing boost efficiency and meet demand? Don’t miss our inaugural Pharmaceutical Online Live digital event on January 22nd. Registration is free thanks to the support of Federal Equipment Company.

SOLUTIONS

Future-Proof Your Lab With The Latest Technologies

Pharmaceutical Aseptic Filling Equipment

Improve Your Small And Large Molecule Formulations

Analytical Method Development And Validation

Hot Air Sterilization Tunnel For Glass Vials And Syringes

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