05.11.22 -- This Biotech Model Makes Money

The growing mRNA vaccine market ― projected to reach $127.3 billion by 2027 ― is fueling high demand for mRNA, which has resulted in a critical need to address mRNA manufacturing bottlenecks.

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

As IV-administered drugs proliferate across numerous therapy areas, pharma sponsors must understand the associated regulatory requirements, study methodologies that generate useful/required information, and create formulations suitable for IV administration.

QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

Explore some of the most relevant engineering activities that are necessary to successfully transfer a product from vial into a prefilled syringe presentation.

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

Continuous improvement has become vital to process excellence and is a key tenet to lean approaches. Discover how companies can empower employees to think about the way they work and be part of improvement efforts.

Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs and also extend to large-scale manufacturing.

Explore four principal CMC challenges for the developers of orphan drugs and the potential emerging solutions.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase 2/3 trials.

A new process was needed for the commercial manufacturing of Ceralasertib, an experimental anticancer therapy with a challenging molecular structure.

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.

One of Premier Consulting’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.

The journey of a novel bioconjugate into clinic is complex and uncertain. Explore the particular challenges when moving a bioconjugate candidate from early development into the clinic.

Since oncology drugs are commonly categorized as highly potent, they require various handling and safety strategies. Toxicologist Joe Galati discusses criteria for evaluating highly potent small molecules.