PharmaceuticalOutsourcingQ42020 - 59


available to other customers early in 2021 for similar HPAPI and
payload development and manufacturing programs.
These new suites will extend the options for companies developing
APIs with even higher potencies.
" Supply from the facility is critical, and by supporting one of our global
partners in the oncology field, we are enabling the treatment of many
cancer patients. Oncology continues to be the leading indication
in biopharma and a key driver for highly potent ingredients such
as antibody-drug conjugates. We continue to add capabilities and
capacity to meet the development and manufacturing needs of our
partners in this field to answer to their increasing demand, " Maurits
Janssen, Strategic Business Development Small Molecules, Lonza said.
" This partnership is a great example of how we can support both
early and commercial-stage biopharmaceutical companies through
innovation in manufacturing technology and flexible business models.
Our customers developing highly potent and increasingly complex
medicines need a partner whom they can trust to handle these toxic
substances throughout their lifecycle and to deliver in sync with their
needs, whether for clinical or for commercial supply. Our partner has
recognized the value in combining expertise in biologics and chemistry
on one site and this investment has expanded our collaboration, " Quote
from Gordon Bates, President Small Molecules, Lonza said.

Flamma to Continue Manufacturing
Partnership of Veklury for Covid-19
Flamma has entered into an agreement with Gilead earlier this year to
be part of the network of manufacturers contributing to the Veklury®
(remdesivir) supply chain.
Flamma will continue to use its sites in Italy and China to support the
need for necessary compounds in an effort to help COVID-19 patients
in need.
" Covid-19 hit very close to home as Flamma is located in the Bergamo,
one of the most affected areas in Italy. Our facility in Dalian, China
remained in full operation after the extended Chinese New Year after
adding proper precautions to protect the safety and health of its
employees, " said Gian Paolo Negrisoli, CEO. " Our Italian team members
utilized the protocols learned from our Chinese team and instituted
them in Italy. This allowed our teams there to continue to support our
customers with little to no interruption to the supply chain. "
The Flamma team has strived to provide continuous manufacturing
support for remdesivir, maintaining timelines for current and
upcoming projects due to the global and local needs.

Veklury (remdesivir) is an investigational nucleotide analog invented
by Gilead, building on more than a decade of the company's antiviral
research. Multiple ongoing international Phase 3 clinical trials are
evaluating the safety and efficacy of Veklury for the treatment of
COVID-19. Based on available data from these studies, Veklury has
been approved or authorized for temporary use as a COVID-19
treatment in approximately 50 countries worldwide.
Additional ongoing international clinical trials continue to further
evaluate the safety and efficacy of Veklury in different patient
populations and formulations, and in combination with other therapies.

Qualigen Engages STA Pharmaceutical
as GMP Manufacturer of AS1411 for
Clinical Trials
Qualigen Therapeutics has signed a contract with STA Pharmaceutical
(WuXi STA), a subsidiary of WuXi AppTec, for GMP production of
AS1411, Qualigen's lead drug candidate for the treatment of COVID-19
and other viral diseases, for potential clinical trials. Preclinical studies at
the University of Louisville's (UofL) Center for Infectious Disease have
demonstrated the ability of AS1411, a novel aptamer-based molecule,
to protect cells from the damaging effects of the novel coronavirus.
" With its industry leading large-scale oligonucleotide manufacturing
capability, this new manufacturing contract with WuXi STA will ensure
we have adequate supply of AS1411 for our anticipated clinical trials in
patients with COVID-19. Securing multisource manufacturing capacity
is an integral part of our planning for this potential broad antiviral
therapeutic, " said Michael Poirier, President, Chief Executive Officer
and Chairman of Qualigen. " Given the persistence of the pandemic,
there continues to be a need to develop treatments for COVID-19. We
are encouraged by the AS1411 preclinical data indicating potential
effectiveness against SARS-CoV-2, the novel coronavirus that causes
COVID-19. Moreover, AS1411 has a strong safety profile as it was
previously administered to more than 100 patients with advanced
cancers and was well tolerated with no evidence of severe side effects. "
In June 2020, Qualigen signed an exclusive license agreement with
UofL for U.S. patent rights covering the treatment of COVID-19
with AS1411. Qualigen intends to work with UofL to complete
investigational new drug (IND)-enabling studies and plans to file an
IND application with the U.S. Food and Drug Administration in early
calendar 2021. Qualigen's aim is to initiate a Phase 2a clinical study in
COVID-19 patients in the first half of calendar 2021.

" This pandemic brought forth many challenges but Flamma
responded to all of them with dedication and a team spirit by working
tirelessly to be a part of the pharmaceutical supply chain to help those
in need " said Kenneth Drew, Ph.D., VP Flamma, USA.

Taysha Gene Therapies Increases
Manufacturing Capacity Through
Partnership with Catalent

During the Covid-19 crisis, Flamma teams in Italy and China have
continued production of important molecules that are critical to help
fight the virus.

Taysha Gene Therapies and Catalent announced a partnership to
support the development and manufacturing of Taysha's gene
therapies at Catalent's Maryland-based gene therapy facilities. |


| October/November/December 2020


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4