Newsletter | January 26, 2022

01.26.22 -- No Joke: A Cell-Therapy Start-Up Meets A Super-Sized CDMO

From The Editor
Featured Editorial
Industry Insights
Scheduling Aseptic Filling For Preclinical And Clinical Batches

Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.

Single-Use Technology For The Most Extreme Processes

Downstream processing for biologics drugs often requires the use of harsh chemicals that can damage single-use technology (SUT) components. CPC designers identified a polymer that helped reproduce an AseptiQuik connectors to handle rough downstream chemicals.

Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?

You wouldn’t hire a house painter to retouch fine artwork, so why would you contract a jack-of-all-trades research organization to pilot a clinical trial with critical endpoints that require specific, in-depth expertise?

Meeting The Small-Batch Pharma Packaging Challenge

A greater number of virtual biotech companies across the globe are launching lower-volume large molecule drug products to address a smaller patient population. Contract manufacturing and contract packaging providers configured for long-running, high-volume packaging processes to support small molecule drug products must now adapt their services, technology, and people to meet the market’s changing needs.  

Are You Taking Full Advantage Of Your CDMO’s Regulatory Expertise?

Diverse organizational experience and an established track record differentiate CDMOs who claim great capability from CDMOs that have proven capability.

Local Treatment Of Non-Small Cell Lung Cancer With A Spray-Dried Bevacizumab Formulation

Development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

How Integrated Chemistry, Manufacturing, And Controls (CMC) Can Help Expedite Early-Phase Development Of Small Molecules: A CRO Perspective

An important lever in early-phase drug development is chemistry, manufacturing and controls (CMC) — all the activities that go into ensuring that a drug product is safe, effective, and consistent.

Building More Resilient API Supply Chains

It is important to pursue a dualistic, longer term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Intensified, Improved Fed-Batch Production Process

The method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.

Ensuring The Efficacy Of Probiotic Products

In the absence of proper handling and packaging, the efficacy of probiotic products can be compromised at any point of the packaging, storage, and transportation process, inversely impacting shelf life and product viability and efficacy for the consumer.

FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies

The FDA requires packaging and distribution systems to protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

Three Key Factors In Supporting Rare Disease Clinical And Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for their drug product manufacturing.

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?”  With an answer, the organization’s content marketing team could ensure their budget and efforts were targeted in the most efficient and cost-effective manner.

Simplify Your Drug Delivery Supply Chain

To bring its lead candidate to patients, a clinical-stage healthcare company leveraged an integrated offering with individual approaches to drug substance, drug product, and clinical trial packaging needs.

Are Real-Time Gene Therapy Test Results Possible?

Along with the complexities of vaccine and viral-based gene therapy process development comes the need for analytical techniques that can help assess quality parameters, especially in real time.

IND Submissions In China: What's Different From Other Regions?

The number of regulatory submissions in China is increasing. This webinar provides an overview of Chinese regulations with a specific focus on data and requirements for clinical trial applications.

Outsourced Pharma Content Collections
Your Supply Chain On Inflation: An Outsourcing Analysis

Outsourced Pharma chief editor Louis Garguilo has been an ahead-of-the-curve chronicler of inflation in the development and manufacturing supply chain. Based on interviews with biopharma professionals — from CEOs to frontline workers and consultants — he’s kept readers informed of rising outsourcing challenges, including the price for materials and services at CDMOs and hard-to-find capacity as supply chains remain strained. Now we’ve collected four of Garguilo’s editorials with outsourcing professionals to help you understand what they and the entire industry is experiencing, what you can expect in 2022, and some steps you might be able to take to mitigate these market forces.