Issue Inside the World of Orphan Drugs

Current Issue: Q2 2019

The Advanced Therapeutics Issue

Inside the World of Orphan Drugs

Our second quarter edition features leading insights from key opinion leaders with findings specific to advanced therapies and orphan drugs.

Also In This Issue

Nice Insight Overview

Where Do  Orphan Drugs  Go From Here?

NICE INSIGHT OVERVIEW: ORPHAN DRUGS Since laws were implemented in the United States, Europe and Japan to encourage the development of drugs to treat rare diseases, the number of orphan drugs on the market has increased. In spite of this, development and approval times can be quite lengthy, and the treatments often carry very high price […]

Viral Vector Manufacturing

Accelerating The Development of Viral Vector Manufacturing Processes

INDUSTRY LEADER INSIGHT: Viral Vector Manufacturing As cell and gene therapies have the potential to rapidly advance through clinical trials to commercialization, there is increasing demand for practical manufacturing solutions for viral vectors that can be readily optimized and scaled. Through ongoing efforts, Brammer Bio and Pall Biotech are each developing and implementing state-of-the-art solutions designed […]

Executive Q&A

Q&A: Building a Successful CDMO Brand

Nice Insight sat down with Brammer Bio’s Mark Bamforth, who is the founder and departing CEO of Brammer Bio, which was recently acquired by Thermo Fisher Scientific. Previously, Mark founded and led Gallus BioPharmaceuticals, which was sold to Patheon in September 2014. We sat down with Mark to discuss his history of building valuable brands from […]

Biological Materials

Keys to Successful Storage, Management and Transport of Biological Materials

Biological materials are shipped from collection and production sites to other locations for analysis and/or further processing. These materials require special handling, and their storage and shipment — generally at very low temperatures — must be achieved in compliance with various local, national and international regulations. Partnering with an experienced and reliable logistics provider can […]

Regulatory Starting Materials (RSMs)

Integrated Outsourcing from RSMs to APIs

As active pharmaceutical ingredient (API) complexity has increased, so too has the raw material supply chain. Drug manufacturers must ensure that these materials meet strict regulatory guidelines regarding impurity levels, that their quality is well documented to mitigate risk and that they can be traced throughout the supply chain. An integrated supply chain with transparency […]

Biopharma

Bioprocess of the Future: What’s In it for Biomanufacturers?

Market forces, capacity constraints, and government policies have driven the bioprocess industry to evaluate new technologies in mAb production with goals to maximize manufacturing flexibility and efficiency while minimizing risk and product cost. Focus is needed on technologies offering the highest return on investment based on ease of implementation, regulatory acceptance, and cost of goods […]

Recombinant Proteins

New Facility Presents Manufacturing Solutions for Recombinant Proteins

With new, state-of-the-art facilities, extensive tech transfer experience and ongoing investments, Grifols provides contract development and manufacturing services for the production of bulk recombinant proteins for use in diagnostics, therapeutics and vaccines. Protein Manufacturing in a Custom Facility at Grifols Our new, $80 million Consolidated Manufacturing Facility (CMF) is located in Emeryville, California. Surrounded and […]

Lean Delivery

Reducing Waste with Lean Delivery in Facility Design and Construction

Applying a lean delivery approach to the design and construction of new facilities can reduce waste, lower costs and improve speed to market. Lean Delivery in the Context of Facility Design and Construction Lean thinking is centered on the successful reduction or complete elimination of waste throughout multiple aspects of a business. Applied to capital […]

Parenteral Solutions

Supporting Small and Emerging Pharma through Collaboration and Specialized Expertise

Growth in the pharmaceutical industry is no longer exclusively driven by large pharmaceutical companies. The switch in the marketplace from a focus on blockbuster drugs to an emphasis on therapies that treat orphan and rare diseases has led to the rise of small and emerging pharma companies founded to advance novel medicines for specialized patient […]

Microbial Fermentation

The Renaissance of Microbial Fermentation

Initially, many smaller biologic drug substances — including recombinant proteins and peptides — were produced via microbial fermentation. However, with the advent of cell-culture systems, interest shifted to mammalian systems to produce larger proteins and antibodies. Now, the introduction of smaller, complex next-generation molecules, such as bioconjugates, antibody fragments and other scaffolds, is once again […]

Past Issues

View all Past Issues

The Outsourcing Issue

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Issue #3 | Volume #4 | Q3 2018

The Next-Generation Issue

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Issue #2 | Volume #6 | Q2 2020

The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018

The Networking Issue

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Issue #3 | Volume #5 | Q3 2019