Newsletter | October 18, 2021

10.18.21 -- C>'s: 6 Challenges To Solve

Featured Editorial
Industry Insights
Analytical Instrumentation: Advancing A CDMO’s Capabilities

To serve client needs as pharma tech advances, a CDMO must know when to acquire new tech, increase overall instrument capacity, and maintain existing validated instrumentation.

Accelerate The Start Of Your Outsourced Pharmaceutical Project

In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a CDMO.

How A Small Biotech Advanced Its Complex Bispecific Antibodies

Surrozen’s president and CEO, Craig Parker, discusses the expertise, resources, and flexibility that advanced its novel and complex bispecific antibody candidates targeting the WNT pathway.

Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

Seed Train Intensification Using High Cell Density Cryopreservation

High cell density cryopreservation, a perfused seed train, and specially designed expansion medium can create shorter lead times, reduce plant footprints, increase flexibility, and reduce cost of goods.

Science-Based Tech Selection For Bioavailability Enhancement

Explore a process based on a series of inputs including the target product profile, drug properties, extensive past project experiences, technology maps, and absorption modeling.

Purification Of Antibodies With Hydrophobic Anion Exchange Resin

A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this resin.

Curing Your Complex Oral Solid Dose Challenges

Oral solid dose experts Amy Trotch and Kieran Coffey offer insight into oral solid dose (OSD) coating techniques and technologies and how to effectively scale and transfer them for commercial manufacturing.

Optimization Of Protein A Chromatography For Trastuzumab

Four Protein A resins were screened for use in a capture step for a Herceptin biosimilar. Multiple parameters were assessed for their performance against the platform resin.

Minimizing API Supply Chain Risks

Partnering with an API CMO can help you navigate challenges you may encounter, ensuring you are using best quality practices and minimizing delays in getting those medicines to market.

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

Could ZipChip Be A Solution For MAM Bottlenecks?
This blog post explores how the use of ZipChip could significantly improve efficiency savings by reducing peptide mapping data collection time from eight days to an overnight experiment.
4 Mistakes You Must Avoid When Outsourcing Vial Fill/Finish

Any errors during the fill/finish stage can delay clinical trials or even prevent meeting funding milestones. Be sure to avoid these four common pitfalls when outsourcing your fill/finish project.

CCRM Collaborates To Tighten Timelines, Prepare Nkarta For IND Filing

Emerging biotech company Nkarta sought a CDMO with a high degree of flexibility that could support its analytical development and manufacturing needs and help advance its programs into clinical trials.

Adeno-Associated Virus (AAV) Production Using Microcarriers

After comparing adherent, suspension, and microcarrier culture for AAV production, scientists believe microcarrier culture is suitable for production of viral vectors to support gene therapy manufacturing.

5 Advantages Of A Single-Use Manifold Configurator

The interface between systems and bags or bottles often proves a bottleneck. Learn how to adapt single-use filling assemblies to meet changing needs in the production and filling process.

Analyzing Product Formulation Using Raman Microscopy

Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

Analog Vs. Digital Weighing Systems

This applicaiton note explains the technical differences between analog and digital weighing systems along with their pros and cons to help you choose the best system for your application.

Viral Vector Vaccine Bioprocessing Handbook

Vectored vaccines show promise in their reliability to induce potent cell-mediated immunity. This paper describes a template to manufacture an adenovirus-based vaccine.

Strategy For ADC Synthesis Using Site-Specific Chemical Conjugation

Learn about the establishment and application of a GMP strategy for site-specific ADCs production using AJICAP technology, a chemical conjugation platform that employs IgG Fc-affinity peptides.

Bring Product Quality Assessment Into Early Clone Selection

Product aggregation is a major stability, efficacy, and safety concern in the manufacturing of antibody therapeutics. This assay enables detection of product aggregates within days of single cell cloning.

Key Considerations For Accelerating Biologics Manufacturing

These strategies for accelerating manufacturing processes and increasing operational flexibility will help you refine your process to achieve optimal outcomes consistently, regardless of molecule.

Innovations In ADC, Highly Potent Substance Containment Tech

This webinar covers a well-designed single-use flexible enclosure system that delivers equivalent if not better containment performance than a hard-shell isolator, at a fraction of the cost.

Life Science Leader Magazine

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