11.07.22 -- Jump-Start Your Outsourcing With This Checklist

Explore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.

Disruptive technologies and advances in analytics are needed to enable wider application of gene therapies in a cost-effective and sustainable way.

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

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

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.

With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

Understanding the obstacles you may face during bioconjugate development, as well as the tools available to help overcome them, can help streamline your product’s path to market.

Instrument vendors can play a critical role in decreasing the training timeline for new and even existing staff at a contract organization.

Gain direction for ensuring successful technology transfers by understanding how to identify common challenges and finding case-based solutions and best practices for overcoming them.

This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

cGMP outlines safety procedures for every basic part of production — defining what needs to be done to keep products safe, operate machinery properly, validate processes, and maintain consistent procedures.

Understand why the demand for CDMOs with experience in the formulation of ophthalmic products is on the rise. 

No single CDMO strategy or outsourcing model is appropriate for every project. Outsourcers can and should evaluate a strategy and partner(s) on a case-by-case basis.

In a recent webinar, experts from Ajinomoto Bio-Pharma Services explored the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Experts share considerations for accelerating and optimizing your early development process.

Gain an understanding of how leading pharmaceutical manufacturers are modernizing their operations, how to stay current with industry trends, and how to ensure long-term relevance in the value chain.

A behind-the-scenes look at efforts to develop a COVID-19 vaccine, as it happened, and the collaborative mindset that brought it here as quickly and safely as possible.

Alan Lahaise, VP, business development, Development & Manufacturing Services, PCI Pharma Services, discusses supply chain issues for the pharmaceutical industry and "dual sourcing" as an approach to eliminate risk.

Tackle both common and unique problems experienced by pharmaceutical and biotech companies trying to manufacture, package, and distribute their drug product.