Newsletter | May 5, 2021

05.05.21 -- Making Sense Of Antibody Epitope Claims

 
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Patient-Centricity: A Drug Development Imperative

Success in biopharmaceutical development is ultimately about facilitating positive patient outcomes. How is patient-centricity influencing the development process today, and what role do CMOs play? 

Technology Selection To Enhance Bioavailability

Most pharmaceutical pipeline drug prospects have low solubility, thwarting absorption when taken orally. This paper covers obstacles to bioavailability and the Lonza tech selection process.

Robust Chinese Hamster Ovary (CHO) Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Electroporation Made Easy For Hard-To-Transfect Cells

Despite its efficacy, electroporation is mistakenly underutilized because of the perceived initial up-front cost in purchasing an electroporator and its association with high cytotoxicity.

Ensuring Consistency In The Supply Of Cell Culture Media

This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

Are You Prepared For The Complexity Of Pediatric Drug Development?

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

Systematic Approach To Early-Phase Technology Transfer

How should you prepare for the initial transfer of lab-scale processes to manufacturing? Ensure systematic production and coordination between formulation scientists and manufacturing personnel.

Achieving Business Continuity In Pharma During COVID-19 Restrictions

To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

3 Considerations When Developing Your LVV Program

When getting a lentiviral vector (LVV) program off the ground, the right CDMO partner can be a game changer. Expertise, production, and equipment are three key considerations in your evaluation.

Hyper-Productivity In Your Monoclonal Antibody (mAb) Purification Step

Learn how a tenfold increase in productivity of 200 g/L/h compared to the industry norm was possible through an intensified Protein A capture process.

50 L HyPerforma DynaDrive vs. Legacy: Single-Use Bioreactor (S.U.B.) Platform Comparison

The Thermo Scientific HyPerforma DynaDrive bioreactor is now enabling scale-up to 5,000 L and process intensification above previous limits while continuing to leverage benefits of S.U.B.s.

Switch To A Nitrogen-Free Cryopreservation System

This study focuses on running costs and carbon emissions associated with cryopreservation equipment, comparing an LN2-free controlled-rate freezer with a typical liquid nitrogen-based system. 

Evaluating Stability Of Biosimilar Monoclonal Antibodies (mAbs) With Micro-Flow Imaging

To ensure similar quality, efficacy, and safety, certain critical quality attributes must be assessed. Here, we demonstrate microflow imaging (MFI) to evaluate the stability of trastuzumab, bevacizumab, and their biosimilars.

Zydis Bio Technology, Grazax And Grastek Revolutionizing Allergy Therapy

Before ALK-Abelló partnered with Catalent, allergen immunotherapies were delivered by injection, limiting the patient population and adherence. Zydis Fast Dissolve Technology changed the paradigm.

Technical Considerations For Developing Oral Solids (Part 2)

In the second installment of this series, experts from Pfizer CentreOne’s global network and partner organizations consider the effects of equipment design and different tablet strategies.

Delivering Clinical Trial Medications Direct-To-Patient

In recent years, the direct-to-patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

Antibody-Drug Conjugate (ADC) Development, Manufacturing With AJICAP Technology

To further explore the capabilities of AJICAP technology, Ajinomoto Bio-Pharma Services presents six comparative analytical methods for drug-antibody ratio determination to apply to site-specific ADCs.

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