APR Sept/Oct 2023 - 15
Captisol, a Ligand Technology
2033 Becker Drive, Suite 310
Lawrence, KS 66047
858-550-5632
www.captisol.com
CAPTISOL®
LEGACY
Captisol is a patent-protected, chemically modifi ed cyclodextrin
with a structure designed to optimize the solubility and stability
of drugs. Captisol was invented and initially developed by
scientists in the laboratories at the University of Kansas' Higuchi
Biosciences Center, for specifi c use in drug development and
formulation. This unique technology has enabled 15 FDA approved
products, including Gilead's VEKLURY, Amgen's KYPROLIS, Baxter
International's NEXTERONE, Acrotech Biopharma L.L.C.'s and CASI
Pharmaceuticals'
EVOMELA, Melinta
Therapeutics'
BAXDELA,
Pfi zer's VFEND IV and Sage Therapeutics' ZULRESSO. The most
recent approval in March 2023 was Novartis' MEKINIST, a pediatric
oral product. There are many Captisol-enabled products currently
in various stages of development.
technology (including 45 in the U.S.) and with the latest expiration
date in 2035. Other patent applications covering methods
of making Captisol, if issued, extend to 2041. In addition to
solid Captisol powder, we off er our partners access to cGMP
manufactured aqueous Captisol concentrate. This product off ering
was established in 2017 to reduce cycle time and increase Captisol
production capacity for large volume drug products. We maintain
both Type IV and Type V DMFs with the FDA. These DMFs contain
manufacturing and safety information relating to Captisol that our
licensees can reference when developing Captisol-enabled drugs.
We also have active DMFs in Canada, Japan, and China.
What sets us apart from other modifi ed cyclodextrins?
A team of experts with 80 years combined experience
working with Captisol and other cyclodextrins.
The scientists at Ligand Pharmaceuticals have developed inhouse
and aided clients in developing parenteral, oral, ophthalmic, nasal
and inhalation formulations with Captisol and other cyclodextrins.
With the recent addition of internal resources and analytical tools,
we are able to provide greater responsiveness for collaborative
feasibility and development programs. In addition, the Captisol
team have successfully completed or assisted with orphan designations
and approvals, preclinical, CMC and clinical development
for ANDA, 505b2 and traditional NDA programs.
We maintain a broad global patent portfolio for Captisol with
approximately 440 issued patents worldwide relating
Our Team is Ready. Are you?
Contact us Today!
to the
www.americanpharmaceuticalreview.com |
| 15
http://www.captisol.com
http://www.americanpharmaceuticalreview.com
APR Sept/Oct 2023
Table of Contents for the Digital Edition of APR Sept/Oct 2023
INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
Facility Tour - Eurofins BioPharma Product Testing
ROUNDTABLE - Drug Delivery
MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
WHITEPAPER - Leveraging Analytical Technology Process for CMC
BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - Cover1
APR Sept/Oct 2023 - Cover2
APR Sept/Oct 2023 - 1
APR Sept/Oct 2023 - 2
APR Sept/Oct 2023 - 3
APR Sept/Oct 2023 - 4
APR Sept/Oct 2023 - 5
APR Sept/Oct 2023 - 6
APR Sept/Oct 2023 - 7
APR Sept/Oct 2023 - 8
APR Sept/Oct 2023 - 9
APR Sept/Oct 2023 - 10
APR Sept/Oct 2023 - 11
APR Sept/Oct 2023 - 12
APR Sept/Oct 2023 - 13
APR Sept/Oct 2023 - 14
APR Sept/Oct 2023 - 15
APR Sept/Oct 2023 - 16
APR Sept/Oct 2023 - 17
APR Sept/Oct 2023 - 18
APR Sept/Oct 2023 - 19
APR Sept/Oct 2023 - 20
APR Sept/Oct 2023 - 21
APR Sept/Oct 2023 - 22
APR Sept/Oct 2023 - 23
APR Sept/Oct 2023 - 24
APR Sept/Oct 2023 - 25
APR Sept/Oct 2023 - 26
APR Sept/Oct 2023 - 27
APR Sept/Oct 2023 - 28
APR Sept/Oct 2023 - 29
APR Sept/Oct 2023 - 30
APR Sept/Oct 2023 - INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
APR Sept/Oct 2023 - 32
APR Sept/Oct 2023 - 33
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
APR Sept/Oct 2023 - 35
APR Sept/Oct 2023 - 36
APR Sept/Oct 2023 - 37
APR Sept/Oct 2023 - 38
APR Sept/Oct 2023 - 39
APR Sept/Oct 2023 - 40
APR Sept/Oct 2023 - 41
APR Sept/Oct 2023 - 42
APR Sept/Oct 2023 - 43
APR Sept/Oct 2023 - FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
APR Sept/Oct 2023 - 45
APR Sept/Oct 2023 - 46
APR Sept/Oct 2023 - 47
APR Sept/Oct 2023 - 48
APR Sept/Oct 2023 - 49
APR Sept/Oct 2023 - QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
APR Sept/Oct 2023 - 51
APR Sept/Oct 2023 - MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
APR Sept/Oct 2023 - 53
APR Sept/Oct 2023 - 54
APR Sept/Oct 2023 - 55
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
APR Sept/Oct 2023 - 57
APR Sept/Oct 2023 - 58
APR Sept/Oct 2023 - 59
APR Sept/Oct 2023 - 60
APR Sept/Oct 2023 - 61
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
APR Sept/Oct 2023 - 63
APR Sept/Oct 2023 - 64
APR Sept/Oct 2023 - 65
APR Sept/Oct 2023 - 66
APR Sept/Oct 2023 - 67
APR Sept/Oct 2023 - CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
APR Sept/Oct 2023 - 69
APR Sept/Oct 2023 - MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
APR Sept/Oct 2023 - 71
APR Sept/Oct 2023 - 72
APR Sept/Oct 2023 - 73
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
APR Sept/Oct 2023 - 75
APR Sept/Oct 2023 - 76
APR Sept/Oct 2023 - 77
APR Sept/Oct 2023 - DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
APR Sept/Oct 2023 - 79
APR Sept/Oct 2023 - 80
APR Sept/Oct 2023 - 81
APR Sept/Oct 2023 - WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
APR Sept/Oct 2023 - 83
APR Sept/Oct 2023 - 84
APR Sept/Oct 2023 - 85
APR Sept/Oct 2023 - Facility Tour - Eurofins BioPharma Product Testing
APR Sept/Oct 2023 - 87
APR Sept/Oct 2023 - 88
APR Sept/Oct 2023 - ROUNDTABLE - Drug Delivery
APR Sept/Oct 2023 - 90
APR Sept/Oct 2023 - 91
APR Sept/Oct 2023 - MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
APR Sept/Oct 2023 - 93
APR Sept/Oct 2023 - An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
APR Sept/Oct 2023 - 95
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
APR Sept/Oct 2023 - 97
APR Sept/Oct 2023 - 98
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
APR Sept/Oct 2023 - 100
APR Sept/Oct 2023 - 101
APR Sept/Oct 2023 - WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
APR Sept/Oct 2023 - 103
APR Sept/Oct 2023 - WHITEPAPER - Leveraging Analytical Technology Process for CMC
APR Sept/Oct 2023 - 105
APR Sept/Oct 2023 - 106
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
APR Sept/Oct 2023 - 108
APR Sept/Oct 2023 - 109
APR Sept/Oct 2023 - MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
APR Sept/Oct 2023 - 111
APR Sept/Oct 2023 - 112
APR Sept/Oct 2023 - 113
APR Sept/Oct 2023 - VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - 115
APR Sept/Oct 2023 - 116
APR Sept/Oct 2023 - 117
APR Sept/Oct 2023 - 118
APR Sept/Oct 2023 - 119
APR Sept/Oct 2023 - 120
APR Sept/Oct 2023 - Cover3
APR Sept/Oct 2023 - Cover4
https://www.nxtbookmedia.com