04.08.21 -- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021

Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

The aim of advanced aseptic processing is the elimination and absolute control of all sources of contaminations — most importantly, human generated contamination. Robotics and isolator-barrier systems will be the core technologies in meeting this endeavor.

New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

Every regulatory agency in the world might look at a sponsor’s filing a little differently. An adept CDMO partner can anticipate challenges based on its experiences and prepare sponsors for, or help them avoid, issues that may arise.

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

A significant obstacle to the release of new medicines is the increasing complexity of drug molecules, which contributes to increased hydrophobicity and poorer water solubility. Technologies that can enhance drug solubility and bioavailability have great potential to improve efficiency within the drug development pipeline. Nanoparticle engineering — the process of shrinking down the size of drug particles — has emerged as a promising solution to this problem.

Implementing precisely tailored, service-optimized aseptic fill/finish processes is crucial for mitigating risks and achieving desired product outcomes. A dynamic, real-time analysis of market trends helps define expectations, proactively mitigate risks, and drive confident decision-making during budget forecasting and production planning while materializing long-term strategic expansion plans.

A global medical device manufacturer sought to improve safety, equipment reliability, overall equipment effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance.

A large multinational pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling OTC products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area — and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence — into compliance with plain language labeling (PLL). Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

In this webinar you'll learn how to assess test method accuracy, information, and data analysis, how to carefully define method transfer objectives for each application, and more.

Clinical trials are so complex, you can’t leave anything to chance. Instead, you need to connect planning and oversight from sourcing to shipping and master such requirements as cold chain, border slowdowns, and data privacy. Learn about five common issues and how to solve them.

The speed and quantity at which novel vaccines, therapeutics, and candidates are currently entering into clinical development is unparalleled, making proactive CDMO selection more important than ever.

There are many important considerations to address in building your new drug program. One of the most critical is funding to get you to your next milestone. In this guide, investment veterans and biopharma executives were asked which questions they often ask (and have been asked). Answer these questions well and your potential investors are that much more likely to support your company’s vision.

This white paper discusses the requirements of designing an autoinjector capable of handling the high pressures necessary for the delivery of highly viscous drug formulations with minimal impact on the patient.

A basic understanding of particles and particle counting to help improve your cleanliness levels is presented in this beginner's guide to particle technology, where you will learn about the physical nature, origins, and behavior of particles.

Pharm Germany GmbH operates as a CMO, producing and packaging pharmaceuticals for customers and distributed in more than 150 countries. This aggregation solution allows them to successfully supply pharmaceuticals to markets that demand serialization or aggregation.

Perfusion is a process that keeps cells in a bioreactor while continuously exchanging culture medium. This e-book explains perfusion, its advantages, and the different types of perfusion available.

Drs. Abdelaziz Toumi and Atul Mohindra from Lonza Biologics address attendee questions from their recent webinar, Gene to IND in 12 Months Without Increased Risk.

Pfizer CentreOne’s oral solid dose experts discuss how advances in the mathematics and engineering involved in understanding the process can tackle challenges and ensure functional coating and drug layering continue to be a viable solution for the next generation of oral solid dose (OSD) drug products. Discover how coatings expertise could transform your OSD drug.