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

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

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.

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?

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.  

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.