Newsletter | November 24, 2021

11.24.21 -- Big-Bio Pro Tackles Outsourcing For Emerging Biopharma

From The Editor
Featured Editorial
Industry Insights
Achieving Large-Scale Ophthalmic Production

Ophthalmic treatments, which include solutions, drops, or ointments used to treat conditions of the eye, require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

Need For Speed: The Key To Successful Multimarket Product Launches

Launching a new drug in the European marketplace presents unique challenges. Numerous official working languages, complex independent regulatory requirements with an overarching framework, and the intricacy and scale of distribution are all characteristics of an EU launch. Jumping these hurdles is a given, but it’s the speed that makes the difference.

Key Considerations For Labeling Your Cell Or Gene Therapy

As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

Five Dangers Of An Insecure API Supply Chain

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

Strategic CDMO: Bringing End-To-End Solutions For Faster Drug Development

Patheon's Bill Weiser discusses how a new generation of CDMOs have positioned themselves to provide strategic solutions that not only complement product development but drive therapies to patients faster.

The Paradigm Shift To Continuous Flow Processes: A Holistic View

On November 30, 2021, Ajinomoto Bio-Pharma Services will present a webinar on managing dangerous chemistries while optimizing waste management to facilitate continuous flow manufacturing in pharmaceutical settings.

What Can You Do To Overcome Immunogenicity And Immunotoxicity Assessment Challenges?

In addition to threatening the safety of patients, drug candidates that fail because of immunosafety issues also cost drug developers significant losses in time and money. Assessing immunogenicity and immunotoxicity potential at the earliest possible stage is critical.

Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness

A rationale-based methodology to address T-cell manufacturing challenges, based on the intended final manufacturing process, proposes a robust, scalable, cost-effective, and sustainable allogeneic platform.

Complimentary Techniques For Determining Relative Response Factor (RFF) Of Non-Isolated Impurities

The determination of the relative response factor (RRF), as it is carried out classically, requires a sample of the isolated impurity. It is possible to determine the RRF of non-isolated impurities by using a combination of high-performance liquid chromatography (HPLC) and nuclear magnetic resonance (NMR).

Outsourced Pharma Content Collections
CEOs And The Complexities Of Outsourcing

Decisions on the strategies and implementation of drug development and manufacturing outsourcing have never been so important to the overall health and direction of both emerging and established biopharma organizations. CEOs today need to take on a higher degree of leadership in making these decisions. To outsource or not, how much, where, and when, have become existential questions of survival, and keys to success (or failure). Chief editor Louis Garguilo investigates how the C-suite can navigate the complexities involved.