APR May/June 2022 - 18

»
ROUNDTABLE
»
Controlled Release
John Tillotson
Pharmaceutical Technical Business Director
ABITEC Corporation
Nathan Dormer
Director of Drug Product Development
Adare Pharma Solutions
Robert J. Bloder
Chief Business Officer
Ascendia Pharmaceuticals
Sandip Tiwari, PhD
Head of Technical Services- NA
BASF Pharma Solutions
Brent Moody
Director Science and Technology
Catalent
Tom Quinci
Director of New Business Development and Partnering
Celanese
Looking back at the past year, how has the pandemic
and associated supply chain issues affected the
development of controlled release products?
John Tillotson, Pharmaceutical Technical Business Director,
ABITEC Corporation: Primarily, the pandemic has challenged supply
chain logistics and increased the manufacturing costs of numerous
excipients including controlled-release excipients. This includes the
cost of developing controlled release products.
Nathan Dormer, Director of Drug Product Development, Adare
Pharma Solutions: The pandemic has invariably affected every
industry's supply chain and Adare Pharma Solutions has been
no exception.
18 |
| May/June 2022
Commercial products with more predictable manufacturing
campaigns and backup raw material vendors have generally fared
better than new research and development programs, since long-term
planning and risk mitigation is integral to marketed products.
For new formulations undergoing prototyping, where excipients are
less defined and constantly evolving, procuring samples or meeting
minimum quantities has come with occasional delays. Overall, our
equipment and material vendors have been very accommodating,
and we are grateful for efforts to maintain availability of their products.
Robert J. Bloder, Chief Business Officer, Ascendia Pharmaceuticals:
Ascendia Pharmaceuticals has responded to the supply chain
disruptions in a number of ways to protect our clients and projects.
We have enhanced the communication and timing pertaining to our
component suppliers and set-up processes to expedite and ascertain
Shannon Kelly
Vice President Business Development and Formulation Technology
Colorcon
Bikash Chatterjee
CEO
Pharmatech Associates-a USP company
Dr. Ali Rajabi-Siahboomi
Vice President - Chief Innovation Officer
Colorcon
Jim Huang, PhD
CEO
Ascendia Pharmaceuticals
Hayden Skalski
Lead Product Application Specialist - Biodetection
Sievers Analytical Instruments

APR May/June 2022

Table of Contents for the Digital Edition of APR May/June 2022

Message from the Editor
Editorial Advisory Board
CN Perspectives
Social Media Connections
BIOPHARMACEUTICALS - Long-Acting Injectable Suspensions
ROUNDTABLE - Controlled Release
QC CORNER - Affinity Approaches to Selective, Sensitive MS Assays
DRUG DELIVERY - Introduction to mRNA-LNPs, Their Manufacture and Future Perspectives
BIOPHARMACEUTICALS - A Next-Generation Workforce for Next- Generation Therapies Preparing for Cell and Gene Therapies
MICROBIOLOGY - Optimizing a Viral Testing Strategy
BIOPHARMACEUTICAL - Assuring Quality of Oligonucleotide APIs and DPs
FACILITY TOUR - Growing to Serve: Eurofins’ Portage, Michigan, Facility Expands to Offer New Capabilities and Services
VENDOR VIEWPOINT - Combining the Best of Both Worlds with Semi-Targeted Metabolomics
VENDOR VIEWPOINT - Method Changes for Bacterial Endotoxins Testing (BET): Steps to Follow for a Straightforward Process
An Interview with Tony Saavedra Sievers DataShare Elite Stoftware
Editor's Top Tech
MANUFACTURING - A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
Equipment Focus
MICROBIOLOGY - Cleaning and Disinfection: An Important Pillar of Contamination Control
P.I.N. Points
Advertiser's Index
APR May/June 2022 - Cover1
APR May/June 2022 - Cover2
APR May/June 2022 - 1
APR May/June 2022 - 2
APR May/June 2022 - 3
APR May/June 2022 - 4
APR May/June 2022 - 5
APR May/June 2022 - Message from the Editor
APR May/June 2022 - Editorial Advisory Board
APR May/June 2022 - CN Perspectives
APR May/June 2022 - Social Media Connections
APR May/June 2022 - BIOPHARMACEUTICALS - Long-Acting Injectable Suspensions
APR May/June 2022 - 11
APR May/June 2022 - 12
APR May/June 2022 - 13
APR May/June 2022 - 14
APR May/June 2022 - 15
APR May/June 2022 - 16
APR May/June 2022 - 17
APR May/June 2022 - ROUNDTABLE - Controlled Release
APR May/June 2022 - 19
APR May/June 2022 - 20
APR May/June 2022 - 21
APR May/June 2022 - 22
APR May/June 2022 - 23
APR May/June 2022 - 24
APR May/June 2022 - 25
APR May/June 2022 - 26
APR May/June 2022 - 27
APR May/June 2022 - QC CORNER - Affinity Approaches to Selective, Sensitive MS Assays
APR May/June 2022 - 29
APR May/June 2022 - 30
APR May/June 2022 - 31
APR May/June 2022 - 32
APR May/June 2022 - 33
APR May/June 2022 - 34
APR May/June 2022 - 35
APR May/June 2022 - DRUG DELIVERY - Introduction to mRNA-LNPs, Their Manufacture and Future Perspectives
APR May/June 2022 - 37
APR May/June 2022 - 38
APR May/June 2022 - 39
APR May/June 2022 - 40
APR May/June 2022 - 41
APR May/June 2022 - BIOPHARMACEUTICALS - A Next-Generation Workforce for Next- Generation Therapies Preparing for Cell and Gene Therapies
APR May/June 2022 - 43
APR May/June 2022 - 44
APR May/June 2022 - 45
APR May/June 2022 - MICROBIOLOGY - Optimizing a Viral Testing Strategy
APR May/June 2022 - 47
APR May/June 2022 - 48
APR May/June 2022 - 49
APR May/June 2022 - 50
APR May/June 2022 - 51
APR May/June 2022 - BIOPHARMACEUTICAL - Assuring Quality of Oligonucleotide APIs and DPs
APR May/June 2022 - 53
APR May/June 2022 - 54
APR May/June 2022 - 55
APR May/June 2022 - 56
APR May/June 2022 - 57
APR May/June 2022 - 58
APR May/June 2022 - 59
APR May/June 2022 - FACILITY TOUR - Growing to Serve: Eurofins’ Portage, Michigan, Facility Expands to Offer New Capabilities and Services
APR May/June 2022 - 61
APR May/June 2022 - 62
APR May/June 2022 - VENDOR VIEWPOINT - Combining the Best of Both Worlds with Semi-Targeted Metabolomics
APR May/June 2022 - 64
APR May/June 2022 - 65
APR May/June 2022 - VENDOR VIEWPOINT - Method Changes for Bacterial Endotoxins Testing (BET): Steps to Follow for a Straightforward Process
APR May/June 2022 - 67
APR May/June 2022 - An Interview with Tony Saavedra Sievers DataShare Elite Stoftware
APR May/June 2022 - 69
APR May/June 2022 - Editor's Top Tech
APR May/June 2022 - 71
APR May/June 2022 - MANUFACTURING - A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
APR May/June 2022 - 73
APR May/June 2022 - 74
APR May/June 2022 - 75
APR May/June 2022 - 76
APR May/June 2022 - 77
APR May/June 2022 - 78
APR May/June 2022 - Equipment Focus
APR May/June 2022 - MICROBIOLOGY - Cleaning and Disinfection: An Important Pillar of Contamination Control
APR May/June 2022 - 81
APR May/June 2022 - 82
APR May/June 2022 - 83
APR May/June 2022 - 84
APR May/June 2022 - 85
APR May/June 2022 - P.I.N. Points
APR May/June 2022 - 87
APR May/June 2022 - Advertiser's Index
APR May/June 2022 - Cover3
APR May/June 2022 - Cover4
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