The Evolution of Therapeutic Monoclonal Antibodies (mAbs)
Enabling technologies are tackling development and manufacturing challenges, paving the way for dynamic mAb innovations. Download white paper
eBook: Key Considerations in Gene Therapy Manufacturing for Commercialization
Compiled by 13 collaborators, this piece looks at the future of gene therapy commercialization including: the regulatory landscape, upstream and downstream manufacturing, analytical approaches and much more. Download eBook
Oligonucleotides: Opportunities, Pipeline and Challenges
Although meaningful progress toward the development of oligonucleotide therapeutics began in the 1970s, nearly a half century later, only six oligonucleotide drugs have been approved by the FDA as of November 2017. However, the field is gaining momentum and the clinical benefits of the dozens of oligonucleotide therapeutics currently in various stages of clinical trials are extremely promising.
This paper discusses the challenges, as well as the technologies helping to overcome the challenges, of commercializing oligonucleotide therapeutics. Also included is a Q&A with Tracy TreDenick, Head of Regulatory and Quality Assurance for BioTechLogic. In this Q&A she discusses BioTechLogic’s firsthand experience and perspectives on commercializing oligonucleotide therapies. Download paper
Gene Therapy CMC Strategies Paving the Way for Commercialization
While significant advancements have been made, gene therapies still present many manufacturing challenges, this paper explores CMC approaches gene therapy developers are applying to increase success rates. Download paper
4 Ste
ps for Managing the Criticality and Challenges of Biopharmaceutical Projects
Biopharmaceutical project management is exceptionally challenging, requiring unique experience and expertise. This paper explores the demands of the field and insights for managing them. Download paper
Process Validation and Regulatory Review in the Age of Expedited Approval Drugs
Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited approval drug, Chemistry, Manufacturing and Controls (CMC) data needs to be generated in about half the time of the traditional process. Of course, an expedited approval classification does not mean that the drug developer can do less. In order to meet these accelerated timelines, analytical methods creation and product and process characterization needs to start sooner, and the process needs to be handled differently. This paper explores those dynamics and offers some revised approach suggestions. Download paper
4 Things You Need to Know About Combination Drug Compliance
Combination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It has grown solidly at a rate of 7.9% CAGR since 2013, and is projected to continue at that rate through 2019.1
Some of the key factors driving this growth include: higher levels of patient compliance, demand for minimally invasive surgeries, opportunities for precise pain relief, quicker healing and governments and non-governmental organizations (NGO) embracing combination drugs for their ease of administration.
However, combination drugs present unique challenges addressed in this paper:
- What is 21 CFR Part 4?
- Understanding the Role of the FDA’s Office of Combination Products
- Bringing Legacy Combination Products into Compliance with 21 CFR Part 4
- Streamlined Approach for Review and Approval of Some Combination Products
