Newsletter | October 20, 2021

10.20.21 -- Intro To Biopharma Facility Design & Layout

 
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Formulation Strategies To Shorten Timelines For First-In-Human Studies

It is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.

Starting Your Sterile Injectables Program Off On The Right Foot

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Explore tips on how to put programs on a firmer footing.

CMOs As Partners For Antibody-Drug Conjugate (ADC) Process Development, Scale-Up, And Optimization

Antibody-drug conjugate (ADC) programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements And Timelines

Manufacturers must understand the challenges associated with creating a CMC strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.

Global Single-Use Supply Chains: Managing Risk, Minimizing Complexity

Biopharma manufacturers can benefit by adopting a global single-use supply chain strategy early in the drug development life cycle and carefully evaluating their single-use equipment and materials suppliers.

Process Optimization And Characterization For Product Safety, Quality

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable risk mitigation tools that maximize efficiency and product quality.

Engineering Respiratory Drug Delivery: Mannitol Case Study

This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

ICP-MS Analysis Of Multiple Trace Elements In Industrial Cell Lines

This poster presents an approach using trace-level multiple-element analysis through inductively coupled plasma-mass spectrometry to support upstream process development and batch quality control.

Leak Test Method Validation: Positive Control Samples For Parenterals

This presentation covers various forms of positive control samples for parenteral products as it relates to validating a leak test method, including which are best suited for each test method and technology.

How To Select An API Partner For Strategic Success

A strategic partner should seek innovation that improves your compound or product’s value. Pfizer CentreOne’s Tom Wilson shares tips for picking the perfect API partner.

Facing The Challenges Of The COVID-19 Pandemic

In alignment with health authorities and a business continuity plan, comprehensive companywide measures ensured ongoing operations and supply continuity through the changing situation.

How To Choose A Sterile Connector

Without a reliable connector, your batch could quickly be rendered worthless. Learn three considerations to give you confidence when selecting fluid handling connectors for your bio application.

Alternative Endotoxin, Non-Endotoxin Pyrogen Test Method

Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs. Another test method that has increasingly been used in the past few years doesn't require animals for pyrogen detection. 

In-Line Monitoring During Downstream Purification

Here we explore a solution that offers in-line real-time monitoring across biopharmaceutical unit operations with little training, machinery, or human intervention.

Single-Use Bags That Resist Vaporized Hydrogen Peroxide

Decontamination by vaporized hydrogen peroxide is common in the pharmaceutical industry. Here, we examine the resistance of RoSS and Bottle RoSS and components against 3% hydrogen peroxide.

Outsourcing Microbial Fermentation To A CMO: Key Considerations

Advances in synthetic biology and genetic engineering have fueled the potential of fermentation-based manufacturing. Here we examine key trends and challenges to the approach.

Regulatory Services For Accelerated Development And Commercialization

Breakthrough therapy designations and other expedited regulatory reviews enable more innovation on shorter timelines to the clinic and commercialization, but they require careful navigation.

From Data To Control: Process Analytics In Upstream Development

Here, we discuss recent strategies for upstream bioprocess analytics and how a thorough process understanding can improve product quality and process efficiency.

Advancements In Antibody Purification

Watch this webinar to learn about emerging monoclonal antibody (mAb) purification approaches, strategies for a diversified antibody pipeline, and how process development reduces risk and speeds time-to-market.

Establishing Data Visibility Across Sponsor/CMO Networks
Learn how you can establish reasonable expectations for data transparency and sharing in sponsor/CMO relationships to ensure effective data management across the supply chain.
Quality By Design (QbD) For Downstream Virus Filtration
Explore how QbD principles can be applied to the downstream virus filtration of monoclonal antibodies (mAbs) and recombinants to simplify validation strategy and increase the robustness of your regulatory filing package.
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Explore on-demand buffer production using new single-use technology.
November 2, 2021
3:00 p.m. GMT

 

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