2017

The Cell and Gene Therapy Industry: Looking at 2016 and Beyond

Politically 2016 was surprising and dramatic here in the United Kingdom and elsewhere. Although it was not surprising for cell and gene therapies per se, the growth that we have seen in this industry has been pretty dramatic around the world as well. The industry has seen investors of all types maintaining their interest in cell and gene therapy, with a number of new deals made: e.g., Bluebird bio and Medigene signed a strategic R&D collaboration and licensing agreement, and…

Ask the Expert Enabling Custom Solutions for Downstream Processing of Future Therapies: An Adenoassociated Virus Case Study

with Orjana Terova Orjana Terova is a purification product manager in the bioproduction division of Thermo Fisher Scientific. In a BPI webinar on 9 December 2016, she discussed the company’s custom resin program for purification of biological products. Thermo Fisher Scientific has dedicated a pilot-plant facility for this program. Terova’s Presentation Speed is the main development driver in downstream processing, but quality and efficiency are always critical. Purification processes need the highest resolution, capacity, salt tolerance, and operation speed possible.…

Accelerated Development Through Strategic Analytical Partnerships

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…

Outsourcing Biosimilar Development

As the debate continues over the high cost of pharmaceutical treatment options, the development of biosimilars continues to play a dominant role in that discussion and will be an important part of the solution. Biosimilar companies are working at a feverish pace to develop the next generation of follow-on products. Outsourcing to a growing group of contract development and manufacturing organizations (CDMOs) is a key strategy for savvy developers to accelerate their products’ launch. Finding the right CDMO isn’t an…

Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

Expanding biopharmaceutical pipelines and therapeutic modalities are feeding a boom in outsourcing key elements of development and manufacturing projects. The rapid growth of the industry as well as of emerging therapeutic areas (e.g., antibody–drug conjugates, biosimilars) challenge sponsors and contractors alike to meet industry needs. The authors in this featured report explore increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on…

Critical Aspects of Technology Transfer to CMOs

Technology transfer in pharmaceutical manufacturing most often is mentioned as occurring between two organizations and involving discrete product lifecycle stages: e.g., a sponsor and a contract manufacturer and from development to manufacturing. According to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use: “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for…

Specialized Outsourcing Services: Antibody–Drug Conjugates

Managing just the conjugation part of an antibody–drug conjugate (ADC) project can be a challenge. So when you consider all the component parts of an ADC, it is understandable why so many related activities are outsourced. At Piramal Grangemouth, we provide conjugation development and manufacturing services. Together with our sister sites in the United States and United Kingdom, we offer payload manufacture and fill–finish capability. The Grangemouth (UK) site has been involved in ADC conjugation services now for over 13…

Introduction: Process Issues in Cell, Gene, and Tissue Therapies

It’s hard to believe that just six years ago, BioProcess International published its first cell therapy supplement, which included just one article on “cell therapy bioprocessing” (1). At the time, most such processing was conducted in special clinical laboratories and academic institutions. As BPI continued to cover this relatively new segment of the biopharmaceutical industry, we heard more about “the product is the process” and “scale out instead of scaling up.” After many trials, errors, and milestones, regenerative medicine has…

Growth Projections for the Regenerative Medicine Market

One of the fastest growing medical markets with great potential, regenerative medicine treats chronic diseases that were once untreatable. Therapy using live cells is increasingly used to replace damaged tissue, deliver gene therapies to target tissues and organs, and stimulate self-healing along with a number of other applications. View the full article below – Login Required Reference 1 Regenerative Medicines Market: Global Opportunity Analysis and Industry Forecast, 2015–2022. Allied Market Research: Pune,Maharashtra, India: August 2016; www.alliedmarketresearch.com/regenerative-medicines-market. 2 Chartrain NA, Williams…

Expansion Platform Components

I first met Chris Mach at the Biotech Week Boston conference in October. We discussed the challenges that biomanufacturers are facing in cell expansion, especially in three specific areas in scale-up systems. View the full article below – Login Required