PharmaceuticalOutsourcingQ42020 - 62


immediately expand our functional clinical and commercial capacity

" The modernization of our equipment is critical to meeting the

for current late-stage customers. This addition also creates a strong

demands of our customers while ensuring both the safety of our

center of cell therapy excellence for Catalent in Europe and will serve

employees and the minimization of our environmental impact. All of

as a hub for the growing cell therapy pipeline. "

this contributes to our Rise-2 growth strategy. " said Dr. Michel Spagnol,

" This agreement with Catalent is an important strategic step for Bone

President and CEO of Novasep.

Therapeutics and is the result of our continuous effort to optimize

This is the latest in a series of investments at the Chasse sur Rhone

our operations, " said Miguel Forte, CEO, Bone Therapeutics. " The

site in response to increased customer demand for Novasep's API

integration of our manufacturing subsidiary into Catalent, one of the

manufacturing services. In 2018 a new 5000L cryogenic Hastelloy

premier contract manufacturers in the cell therapy space, significantly

reactor was added. Containment capabilities have been reinforced

increases our operational flexibility. It enables Bone Therapeutics to

with a new 1.5m² Hastelloy filter drier equipped with isolator for

maximize the efficient use of our manufacturing assets by combining

handling highly potent compounds. The pilot plant has been extended

the manufacturing facility and specialist operators with Catalent's

with a third clean room and a new Hastelloy filter drier. Finally, the

global network of clinical and commercial manufacturing facilities.

analytical laboratories have been extended & additional equipment

This will ensure the most efficient ongoing global production of

installed (LC-MS GC-MS).

ALLOB. It also allows us to further focus on our core activity: developing
innovative cell-based treatments for conditions with high unmet
medical needs. This deal will facilitate our efforts to bring ALLOB more
quickly within the reach of patients around the world. "

Thermo Fisher Scientific, Innoforce Partner
to Establish Facility in China
Thermo Fisher Scientific and Innoforce have signed a joint venture

In addition to the expansion in Gosselies, validation of Catalent's new

agreement to establish a new pharma services facility in Hangzhou,

32,000 square-foot (3,000 square-meter) cell therapy development

China, for integrated biologics and steriles drug development and

facility in Houston, Texas is underway and scheduled to be completed

manufacturing. The new facility is expected to be completed in 2022.

by the end of 2020.

The new state-of-the-art Good Manufacturing Practices (GMP)

Novasep to Expand Capacity, Increase
Flexibility in API Manufacturing Workshop

facility will become part of Thermo Fisher's extensive global pharma

Novasep is investing €6.5 million to expand capacity & increase
flexibility in an API manufacturing workshop at its Chasse-sur-Rhône
site (69 - France).

clinical trials packaging and logistics. The Hangzhou site will also

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.

Products Administration (NMPA), the U.S. FDA and appropriate EMEA

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. "
Pharmaceutical Outsourcing |


services network, which includes leading capabilities for drug
product development, biologics manufacturing, sterile fill-finish,
incorporate stringent quality control processes that meet or exceed
regulatory guidelines established by the China National Medical
" Our agreement with Innoforce will provide critical support in helping
to meet the high demand for biologics in China, " said Michel Lagarde,
executive vice president, Thermo Fisher Scientific. " The addition of the
Hangzhou site will expand our existing global network and provide
drug development and manufacturing services for customers in China,
as well as for global customers seeking capabilities in the region. "
" To successfully bring novel therapies to market domestically and
internationally, emerging biotech companies increasingly need
partners with expertise in development and manufacturing and deep
global regulatory knowledge. Through our partnership with Thermo
Fisher, we can offer an accelerated pathway for biopharmaceutical
manufacturers in China - and outside as well - to bring innovative
therapies to the world, " Innoforce CEO Yuling Li said.
Until the site is operational, new and existing customers can access
Thermo Fisher's global biologics and sterile network, which includes
sites across the U.S., Europe and Asia-Pacific, and then seamlessly
transition to the new Hangzhou site after completion.
| 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