Newsletter | September 16, 2021

09.16.21 -- How To Find (and Manage) Biotech Consultants

Featured Editorial
Industry Insights
Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements

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

Ensure Quality Through Process Optimization And Characterization

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable tools in minimizing risk, as well as maximizing both efficiency and quality.

Overcoming Cell Therapy Supply Chain Challenges

To ensure the industry can realize the potential of cell and gene therapies we must develop improved solutions that reliably support the control and transport of critical cell and gene therapy (CGT) raw materials and products.

Moving Biotherapeutic Candidates From Late Discovery To The Clinic

It's estimated that only 1 in 1,000 preclinical candidates reaches the commercial market. This article discusses how to prepare for a successful transition to bring a drug candidate from discovery to the clinic.

Curing Your Complex Oral Solid Dose Challenges

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

Selecting A CMO: Top Considerations

Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.

The 5 Pitfalls Of API Development

No matter where you are in the API development life cycle, early planning makes a big difference. Every plan should keep these five key milestones — and potential pitfalls — in mind.

A Legacy Of Quality Product Delivery With A New Twist

A leading CDMO headquartered in Barcelona, Spain, raises the bar in the delivery of pharmaceutical ingredients with its fit-for-purpose small molecule development and manufacturing capabilities and its new approach to project management.

Quality Results Faster With Integrated Pharmaceutical Development Platform

How an integrated pharmaceutical development platform can meet the needs of both analytical development and QC teams through shorter turnaround times, fewer repeats and higher quality.

Extractables Testing On Single-Use Connectors

Appropriating BPOG testing on single-use connectors to mitigate the risks of extractables and leachables (E&L), as demonstrated in this article, is crucial to delivering safe and effective drugs.

One-Step Isolation And Activation Of Naive And Early Memory T Cells

In this application note we demonstrate nearly 100% recovery of naive and early memory T cells using Gibco CTS Dynabeads CD3/CD28 beads. 

Intensifying Upstream Processing: Implications For Media Management

This e-book discusses the benefits of process intensification and the potential implications on media management. Also discussed is the value in conceptual design to assist with the logistics of the media journey.

Are You Protecting Your Employees During HPAPI Manufacturing?

As biomanufacturers venture into the rapidly growing market of HPAPIs, it is important to consider whether they have the resources and capabilities to protect their product and their employees.

The Faster Path To Self-Administration

Explore how to quickly transition your product from prefilled syringe to auto-injector with a partner who can anticipate equipment and process needs.

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