05.26.23 -- Key Considerations For Developing Next-Generation Antibody-Drug Conjugates

Potential pharmaceutical products are highly regulated and must be rigorously tested to ensure safety, purity, and performance. Discover a hybrid rheometer that offers capabilities beyond the traditional viscometer.

In manufacturing, nothing is more important than the quality of the materials being used. Explore why steel quality is the fundamental building block upon which all successive value-added steps are laid. 

As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe.

Review a full life cycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

This paper provides a lyophilization process overview, diving deeper into the subject of freeze-drying, reviewing drying pressure, temperatures, cycle optimization, scale-up considerations, and storage. 

Explore the role of the system owner, starting with what you need to achieve operational readiness, as combined to form the two key disciplines of good engineering practice and human performance.

The more efficient the API synthesis, the lower the cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

In the life sciences industry, many drugs on the market today have been approved for indications for which they were not originally developed. Learn about drug repurposing and more.

This biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.

There are several challenges to effectively analyzing CIP operations. Seeq tools help create a process model that can be applied across cleaning circuits and amended with circuit-specific data.

A global healthcare company specializing in lifesaving medicines and technologies was looking for online TOC measurement for its production site. Discover which analyzer the site chose and how they came to this decision. 

ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.

Nasal spray administration of medicine offers advantages over oral and intravenous (IV) delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

Explore opportunities with the introduction of high-capacity protein A resins, how and when multicolumn chromatography is beneficial, and how emerging technologies can address bottlenecks.