PharmaceuticalOutsourcingQ42020 - 58

INDUSTRY NEWS

Novasep to Expand Capacity, Increase
Flexibility in API Manufacturing Workshop
Novasep is investing €6.5 million to expand capacity & increase
flexibility in an API manufacturing workshop at its Chasse-sur-Rhône
site (69 - France).
The revamping of this workshop and installation of two new synthesis
reactors (4000L Hastelloy & 1600L glass lined) is intended to increase
the plant flexibility and its capacity for low to medium volume APIs,
addressing the growing needs of the industry for targeted therapies.
The two new reactors are equipped with a high-performance
thermal system & benefit from a high level of automation. The
project also involves repositioning the high-pressure hydrogenation
reactor, (1500L,15bar), currently located in the workshop, in a new
dedicated area.
Work has already started, and the construction of the utilities building
is nearing completion. This investment will be fully operational by the
end of 2021.
" Upgrading this workshop with the addition of two new reactors will
enable us to continue modernizing our Chasse-sur-Rhône site's API
manufacturing facilities, whilst improving flexibility and productivity, "
said Jean Bléhaut, president of the Synthesis Solutions Business Unit
of Novasep. " These investments will also reduce our environmental
impact by optimizing energy consumption. This is an opportunity
for us to respond to social and environmental challenges using
technological advances. "
" The modernization of our equipment is critical to meeting the
demands of our customers while ensuring both the safety of our
employees and the minimization of our environmental impact. All of
this contributes to our Rise-2 growth strategy. " said Dr. Michel Spagnol,
President and CEO of Novasep.
This is the latest in a series of investments at the Chasse sur Rhone
site in response to increased customer demand for Novasep's API
manufacturing services. In 2018 a new 5000L cryogenic Hastelloy
reactor was added. Containment capabilities have been reinforced
with a new 1.5m² Hastelloy filter drier equipped with isolator for
handling highly potent compounds. The pilot plant has been extended
with a third clean room and a new Hastelloy filter drier. Finally, the
analytical laboratories have been extended & additional equipment
installed (LC-MS GC-MS).

To support access, AmerisourceBergen will serve as a network
administrator and place orders with the CDC on behalf of qualified
and eligible Good Neighbor Pharmacy and Elevate Provider Network
members. AmerisourceBergen will receive a direct allocation of
COVID-19 vaccine for independent retail pharmacy customers once
there is adequate supply of COVID-19 vaccine to support broader
inoculation efforts and vaccination is recommended for individuals
beyond the initial critical populations. COVID-19 vaccine will be
distributed by the CDC's central distributor.
" Independent community pharmacies have been fearless and have
risen to every challenge that COVID-19 has presented this past year.
Independent pharmacies are critical sites of care in their communities
year-round and many Americans turn to their local pharmacy for a
variety of immunizations annually, " said Brian Nightengale, President
of Good Neighbor Pharmacy. " We are beyond proud to help our
independent pharmacies gain access to COVID-19 vaccine. They
are already poised to join this next phase in the fight against the
coronavirus and continue to support their communities. "
This effort will help jurisdictions augment access to COVID-19
vaccine when supply increases. With more than 90 percent of people
living within 5 miles of a community pharmacy, pharmacies have
unique reach and ability to provide access to COVID-19 vaccine
and support broad vaccination efforts. This program will provide
critical vaccination services for the U.S. population, with vaccine
administered at community pharmacy locations at no cost to
recipients. The program will be implemented in close coordination
with jurisdictions to enable optimal COVID-19 vaccination coverage
and vaccine access nationwide.
Good Neighbor Pharmacy is AmerisourceBergen's independent
community pharmacy network.

Lonza Announces Opening of New Facility
for ADC Payload Manufacturing
Lonza inaugurated the first of two manufacturing suites for antibodydrug conjugate (ADC) drug-linker (payload) manufacturing at the
Visp (CH) site. This first manufacturing suite handles compounds
with occupational exposure levels down to 1ng/m3 and is dedicated
to the manufacturing platform for ADC drug linkers. This expansion
underlines the strategic position of ADCs in the Lonza portfolio,
with the company developing and producing all components of
these increasingly important cancer treatments: cytotoxic payloads,
antibodies and the required linkers on one site.

AmerisourceBergen Reaches
Agreement with CDC to Support
Access to COVID-19 Vaccine

Due to COVID-19 measures, the opening was held as a virtual opening
ceremony, connecting multiple customers and Lonza sites worldwide
after the first process validation was completed successfully and
manufacturing for in-market supply started.

AmerisourceBergen has reached an agreement with the U.S. Centers
for Disease Control and Prevention (CDC) to include Good Neighbor
Pharmacy and Elevate Provider Network members in the Federal
Pharmacy Partnership Strategy for COVID-19 Vaccination.

The first of two state-of-the-art, highly-potent API (HPAPI) suites
supports a global biopharmaceutical partner by securing their longterm supply of highly-potent ADC payloads. The suite has been
in operation since March of this year. A second suite will become

Pharmaceutical Outsourcing |

58

| October/November/December 2020



PharmaceuticalOutsourcingQ42020

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
Roundtable
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
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