Newsletter | April 8, 2021

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

 
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Is Not Using A CDMO Slowing Down Your Process Development?

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.

Robotics, Isolators, And Restricted Access Barrier Systems (RABS)

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.

Optimizing Filling Technology To Minimize API Loss

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.

Understanding Multinational Regulatory Filings: New Chemical Entity

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.

Align Your CMC Strategy With Clinical Path Requirements And Timeline

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.

Nanoparticle Engineering: Revolutionizing Oral Drug Delivery

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.

Achieving Success With Market Intelligence Integration For Aseptic Fill/Finish

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.

The Value Of Reliability Assessments And Benchmarking In Life Sciences

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.

Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

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.

Test Method Migration Considerations For Container Closure Integrity Testing (CCIT)

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.

5 Common Clinical Supply Chain Speedbumps

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.

Assure Scalability, Overcome Regulatory Hurdles, And Speed Time-To-Clinic

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.

Growing Your Biopharma: Ten Questions You’re Likely To Face From Investors — And How To Respond To Them

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.

Combining Human Needs With High-Viscosity Formulations

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.

An Introduction To Particle Technology In Pharmaceutical Manufacturing

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.

CMO Meets Serialization And Aggregation Demands With Case Aggregation Kit

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 Cell Culture Overview

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.

A Q&A With The Experts: Reducing Timelines From Gene To IND

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.

Coating: Curing Your Complex Oral Solid Dose Challenges

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.

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