Newsletter | July 20, 2021

07.20.21 -- Qualification Considerations For A "Factory-in-a-Box"

Featured Editorial
Industry Insights
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.

Complex Molecule Development: Early Considerations To Avoid Failing Later

How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

Cold Chain In 2021: COVID-19's Continued Influence

As we eagerly enter 2021 and prepare this year’s cold chain industry predictions, we reflect on the events of 2020. Our three predictions all show how COVID-19’s influence persists, and, in some instances, may have a long-term ripple effect.

How Oral Solid Coating Technologies Can Enhance Delivery Strategy

Oral solid dose (OSD) remains a dominant form in drug delivery and development. Discover advances that improve oral solid stability and integrity through technology platforms and coating technologies.

Phase-Appropriate Drug Development: Validation Process

The drug development process is among the most complex, costly, and regulated of human pursuits and the statistical chances of success are horribly low. However, when we couple new trends in patient disease knowledge with a disciplined phase-appropriate process for drug development, a more cost-effective, success-oriented model emerges. Let’s consider phase-appropriate development by applying it to process validation.

OCELOT System Control: Painless Precision For Downstream Automation

OCELOT System Control, a new automation software platform from Asahi Kasei Bioprocess America (AKBA), offers all the capabilities of its competitors but with a user-friendly platform that simplifies implementation and operation.

Successful Techniques For Progressing Biotherapeutic Candidates From Late Discovery To The Clinic
The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only one in 1,000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. In our latest white paper, we help you to prepare for a successful transition to bring your 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.

New, LN2-Free Solution For Cryogenic Transport Of Advanced Therapy Medicinal Products (ATMPs)

Administration of cell therapies, in clinical trials or as commercial products, involves complex logistics between sometimes numerous partners and sites, making timing critical. A better understanding of the boundaries not to be crossed, in terms of transit time and temperature, to maintain cell integrity post-thaw, is studied here.

Leveraging A Biomanufacturing Legacy To Support New Business

Seven diverse experts discuss how Grifols Recombinant Protein CDMO's legacy and recent investments support its future in providing recombinant protein CDMO services.

IV Solution Expansion

In recent years, hospitals, clinics, and other users have experienced chronic shortages of medical solutions. The Solutions for Life initiative is a billion-dollar investment in meeting nationwide demand for these products, today and tomorrow.

Adeno-Associated Virus (AAV) Production Using Microcarriers

Scientists have successfully adapted an adherent HEK293 cell line to grow in animal component-free and serum-free suspension conditions in shaker flasks. After comparing adherent, suspension, and microcarrier culture for adeno-associated virus (AAV) production, they believe that microcarrier culture is suitable for large-scale production of viral vectors to support future gene therapy manufacturing processes.

Test Method Development, Experimental Design, And Positive Controls For Package Integrity

Given that the experimental design has only two conditions, leaking and nonleaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

Understanding Your Customers’ Outsourced Service Roles And Responsibilities

ISR was contacted by the vice president of content marketing at a Top 5, global CDMO with the question, “How do we better understand our customers’ roles and responsibilities as they relate to outsourced contract manufacturing services?” The client had three goals with this question. First, the client had drafted preliminary personas they wanted to refine and pressure test. Second, the client was interested in identifying the marketing channels their customers and prospects preferred to use so the client could tailor messaging for those media. Finally, the client wanted to get a better sense of decision makers’ roles in the outsourcing decision-making process. With this information, the organization’s content marketing team could ensure their budget and efforts were targeted in the most efficient and cost-effective manner.

Eliminate Drug Discovery Errors Before They Happen: Why Picking The Correct Binding Technology Is Critical To Success

Starting with the right tool is crucial in saving you time and money in the drug development process. This binding technologies toolbox covers temperature related intensity change (TRIC), surface plasmon resonance (SPR), differential scanning fluorimetry (DSF), and isothermal titration calorimetry (ITC).

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