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WHITE PAPERS AND CASE STUDIES

• A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter

  A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more. 

• Managing Risk In Single-Use Systems Design And Implementation

  Implementation of SUS can shift responsibilities to SUT suppliers within key areas, including design and sterilization methods that must be controlled and validated. 

• Metrics That Matter For Contract Manufacturing

  For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.

• How eConsent Is Changing The Informed Consent Process

  Learn how informed consent — providing a potential participant with enough information about a study to allow for an informed decision about their participation — is a critical step for enrolling patients in clinical trials.

• AAV Vector Manufacturing: Transfection Matters

  Optimizing the transfection process and its efficiency is paramount to boosting vector titers during scale-up and manufacturing of AAV vectors with new generation transfection reagent addressing large scale manufacturing constraints.

• Fast Steering Mirrors (FSM) - Design, Performance, And Tuning Of Piezo-Based Mechanisms

  In free space optical communication (FSO), large amounts of data are “beamed” between two points – on earth, on aircraft or between satellites in space. Fast steering mirrors (FSM) are one means to compensate for disturbances that could keep the laser beam from hitting its target receiver precisely. 

• Peptide Synthesis: Delivering Cost-Effective Strategies

  For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.

• Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion

  The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Non-core manufacturing activities, including the weigh and dispense steps in the process liquid and buffer preparation, were identified as bottlenecks impacting the overall production schedule. The proposed solution would provide ready-to-hydrate, trustedweight dry powder chemicals. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.

• Real-Time Viable Particle Detection For Definitive Root Cause Investigation

  Rather than traditional methods, a real-time viable particle counter is key to providing process improvement in real-time viable particle detection for definitive root cause investigation.

• The Relief Through Customized Manifolds

  A CMO faced a challenge with the commercialized automated filling of small bags with a volume of 500ml. There were 1000 bags to fill per batch. None of the single use manifold assemblies matched the requirements of the CMO. Read how a customized solution of single use manifolds was the solution.

• Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

  Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a flexible CDMO is the key to success.

• How To Accelerate Global Market Growth With Agile Product Sample Pouching Programs

  A market-leading consumer health products division of a multi-national pharmaceutical company sought to grow their brand with an innovative, new vitamin product. This launch would involve complimentary sample pouches that could be distributed across a range of channels to reach as many consumers as possible. That is where Jones Healthcare Group stepped in.