Newsletter | May 11, 2022

05.11.22 -- This Biotech Model Makes Money

From The Editor
Featured Editorial
Industry Insights
Increasing mRNA Capabilities, Capacity

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.

Align CMC Strategy With Clinical Path Requirements And Timelines

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.

Developmental Testing Of IV Solutions

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.

Applying Quality By Design To Pharmaceutical Research And Development

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.

Considerations For Migrating From Vial To Prefilled Syringe

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

Top Four Considerations For Tech Transfer Performance

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.

Analytical Considerations For Biopharmas During Commercialization

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.

Making Continuous Improvement Part Of The ‘Everyday’ In Pharmaceutical Clinical Services And Commercial Drug Packaging

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.

Pediatric Dosage Forms: Reformulation And Development Expertise

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.

Accelerating The Development Of Orphan Drugs For Rare Diseases

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

Adapting To Change: API Custom Development And Manufacturing

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 Better Route For Commercial Manufacture: Improved Yields And Operability

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

Examining The Emergence Of Unit- And Bi-Dose Nasal Sprays

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.

The Composition And Value Of A Portfolio Analysis

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.

Early Development To Clinic: De-Risking A Bioconjugate’s Journey

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.

A Toxicologist’s Viewpoint On Developing Oncology Drug Products

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.

Outsourced Pharma Live
Biopharma CEOs And CDMOs: How Involved Should They Be?

Should CEOs be wading in the outsourcing weeds — involved in not only the strategy, but day-to-day management and activities at CDMO partners? In March 2022, Outsourced Pharma Live hosted three experienced CEOs who shared their experience, outlook, and advice that can help you no matter your position within the outsourcing development and supply chain at your organization.