Also in This Issue

The FDA Recently Validated a Continuous Manufacturing Pharma Process Line—What Do You Think This Means for the Future?

Roundtable participant’s speak with Nice Insight & weigh-in on the future of product processing after the FDA’s validation of a continuous manufacturing process line.

Q: With Respect to Supplier-Partner Relationships, What is Your Preferred Collaboration Model?

Nice Insight asks industry leaders, “With respect to supplier–partner relationships, what is your preferred collaboration model?”

Fill-Finish

Harnessing CDMO Expertise for Fill-Finish and Inspection of Sterile Pharmaceuticals

As biopharmaceuticals continue to grow in popularity and biosimilars become more commonplace, research and development in sterile drug production will evolve.

CDMOs Crucial for Bringing Promising Next-Generation Therapies to Market

More than 500 companies are involved in cell therapy technology, while the market for gene therapy is predicted to increase to over $200 billion.

Investment Recovery for Pharma Equipment – Part 2

Many companies implement redeployment programs within their manufacturing networks. Often, the same makes & models of equipment are used in different facilities.

Process Performance Qualification Prep: a Strategic Approach Leads to Success

Successful process validation cannot be achieved unless manufacturers thoroughly understand their processes & the impact of process variations on product quality.

Nice Insight Overview: The Key to Pharma’s Next Generation Success

Evolving markets are prompting drug owners and developers to pursue new business models in the post-blockbuster era.

AMRI: Solidifying and Modernizing Brand Identity

Design Logic Process and Reasoning Behind Brand Identity

Nice Insight Annual Pharmaceutical Equipment Report

Pharma manufacturers are turning to technology and systems suppliers for technological expertise that once was held internally.

Q: What Have You Found to be the Greatest Benefit from Close Collaboration Partnership Models?

Nice Insight asks industry leaders, “What have you found to be the greatest benefit from close collaboration partnership models?” How close is too close?

In Close Supplier-Partner Relationships, What Pitfalls Do You Try to Avoid? How Close is Too Close?

Nice Insight asks industry leaders, “When working in close supplier-partner relationships, what pitfalls do you try to avoid?”

How Are Equipment Manufacturers Perceived in the Marketplace by Their Customers?

Equipment suppliers are increasingly important to drug owners and developers, as are their perceptions of companies who can help them achieve their goals.

Innovating Equipment: Inline Buffer Dilution Technology

Inline buffer dilution (IBD) has been recognized as a game changer and a highly optimized solution to a critical processing step.

Novel Equipment Solutions: Leading to Manufacturing Efficiency and Productivity

Pharmaceutical companies are increasingly turning to equipment suppliers for forward-thinking solutions, novel equipment and process technologies.

Applying Advanced Protein Engineering Technologies to Biotherapeutic Development

A number of enzyme replacement therapies (ERTs) have been launched, or are currently in development, with ongoing investment in rare disease treatments anticipated.

Delivering on Unfulfilled Promises – Building a CDMO

Many conventional CMOs have actively pursued acquisitions and internal investments, some funded through initial public offerings, in order to become CDMOs.

Future Pharma Partner Models: Pharma 3.0

Pharma 3.0,” “Next-Gen Pharma,”“Future Pharma” — contract service providers are redefining their mission and reframing their strategic roles with customers.

Patient-Centric Drug Development: Designing Medicines to Succeed

Many conventional CMOs have actively pursued acquisitions and internal investments, some funded through initial public offerings, in order to become CDMOs.

Quality by Design: Transforming 21st Century Pharmaceutical Manufacturing

The QbD concept has been widely adopted as a standard of practice for manufacturers, including those in the automotive, electronics & chemical processing industries.

Analytical Method Development: Key to Process Development

Increasing cost pressures and the move toward value—or—evidence-based medicine is placing pressure on pharmaceutical companies to be first to market.

Cenexi: A Brand Evolution

A research-driven positioning project for Cenexi focused on growing equity with a more memorable aesthetic and messaging aligned to market needs.

Q: When it Comes to Processing, What Technology Will Have the Most Impact on Pharma Processing Over the Next 10 Years?

Nice Insight asks industry leaders what technologies will have the most impact on pharma processing over the next ten years.

Pharma’s Renaissance Continues

Pharma’s renaissance is being driven by more focused spending, smarter approaches to the patient & more effective quality strategies for proactive compliance.

Joint Venture Contract Services – A CDMO’s Approach to Being a True Partner

Largely due to its low profit margin, pharmaceutical companies often rely on contract manufacturing to achieve economies of scale, especially for small-molecule APIs.

Evolving Strategic Partnership Models

Pharmaceutical development is growing as the industry gains momentum in response to a broad range of market, regulatory and social trends globally.

Track & Trace Systems for Serialization and Aggregation

The ability to track and trace pharmaceutical product in the distribution channel has always been a regulatory imperative; those regulations are evolving.

Function and Form: Advanced Pharma Packaging Design and Processing

Contract packaging firms that offer low cost, timeliness, flexibility combined with assured high quality, can add real value by providing solutions.

Sustainable Strategies for Contract Development and Manufacturing Service Growth

Members of the “Who’s Who” of CMO/CDMO leadership are pursuing robust growth strategies to keep the CDMO segment energized and interesting.

Embracing Formulation Expertise to Extend Exclusivity & Improve the Patient Experience

Offering potential exclusivity & access to larger markets, reformulation efforts can prove extremely valuable to pharmaceutical & biopharmaceutical manufacturers.

Creating a Global C‘R’DMO for the Future of (Bio)pharma: Effective Strategies and Tactics

Reliance on contract service providers is increasing in the industry as drug makers seek to increase efficiency, productivity & advanced technologies.

Accelerating Approval and Reducing Costs of Spray Dried Drugs through Development by Design (DbD)

Effective application of its Development by Design (DbD) approach has enabled Hovione to accelerate spray drying development, reducing cost & time to patients.

Issue Q1 2019

The Business Development Issue

View Issue »
Issue #1 | Volume #5 | Q1 2019
Issue Q4 2018

The Innovation Issue

View Issue »
Issue #4 | Volume #4 | Q4 2018
Issue Q3 2018

The Outsourcing Issue

View Issue »
Issue #3 | Volume #4 | Q3 2018
Issue Q2 2018

The Next-Generation Issue

View Issue »
Issue #2 | Volume #4 | Q2 2018