PharmaceuticalOutsourcingQ42020 - 60

INDUSTRY NEWS

" Through this partnership, we will be able to enhance our existing
manufacturing capabilities to support Taysha's broad gene therapy
pipeline, " said RA Session, II, President, Founder and CEO of Taysha.
" We are focused on ensuring that we can provide access to potentially
curative gene therapies for thousands of patients by establishing this
robust infrastructure early. "
Taysha has an established partnership with UT Southwestern Medical
Center that allows it to access the institution's CGMP-compliant
manufacturing suite, which has a capacity of over 500 liters as well
as additional 100-liter toxicology material capacity. In addition, Taysha
intends to establish its own commercial-scale, CGMP manufacturing
facility to meet future demand for its gene therapy product candidates.
This new partnership with Catalent intends to rapidly expand Taysha's
manufacturing capacity and will support future manufacturing needs
for several of Taysha's gene therapy programs, including treatments
for CLN1 and Rett syndrome.
" Given Taysha's large and growing pipeline of gene therapies, we
wanted to plan for potential increased manufacturing needs above the
GMP facility at UT Southwestern and our own planned manufacturing
facility, " said Fred Porter, Ph.D., Chief Technical Officer for Taysha. " We
believe that this partnership is critical to our strategy for future clinical
and commercial supply of our gene therapy product candidates. "
" Catalent is committed to gene therapy partnerships at all stages
of development and manufacturing, " said Manja Boerman, Ph.D.,
President, Catalent Cell & Gene Therapy. " With our experience in process
and analytical development and deep expertise in adeno-associated
viral vectors, combined with our growing footprint, we are able to help
companies manufacture patient material and reach the clinic faster. "

Syneos Health to Acquire Synteract
Syneos Health® announced an agreement to acquire Synteract, a fullservice CRO focused on the biopharma segment.
Synteract's client base comprises primarily pre-revenue companies, a
segment in which Syneos Health has growth opportunities. Synteract's
700 employees across North America, Europe, Asia Pacific and Africa
have supported more than 4,000 Phase I-IV clinical trials across 26,000
sites in more than 60 countries.
The acquisition will enhance Syneos Health's leading position in
the marketplace, particularly for serving customers across the small
to mid-sized (SMID) category - further diversifying the Company's
customer base and expanding support to the high-growth prerevenue segment. According to industry estimates, funding to the
biotech sector has shown no signs of slowing down, remaining near
all-time record highs. Syneos Health continues to experience strong
SMID demand with double digit year-over-year pipeline growth.
Syneos Health will also leverage its global infrastructure and
integration expertise to optimize operational efficiencies and drive
improved margins.
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60

Upon the transaction closing, Synteract will maintain its brand and
management, operating as a Syneos Health Business Unit.
" Synteract is one of the leading mid-sized, late-stage-focused CRO
platforms with global reach and an attractive focus on the highest
growth customer segment in the CRO space fueled by near-record
funding levels, " said Alistair Macdonald, Chief Executive Officer,
Syneos Health. " With Synteract, we will strengthen our leadership
across the entire SMID category while we continue to drive growth
among large biopharma customers. Importantly, we share operating
and cultural philosophies built around finding the best combination
of product, process and technology to fuel innovation. I look forward
to welcoming Synteract to the Syneos Health family, as we collectively
work to change patients' lives. "
" Joining Syneos Health combines our emerging biopharma expertise
and expands our differentiated delivery model, " said Steve Powell,
Chief Executive Officer, Synteract. " We are excited to join the Syneos
Health team, as they provide increased global scale, service breadth
and the technology infrastructure that will drive continued growth.
On behalf of our management team, I thank our dedicated employees
and customers who have made this combination possible, as well as
Amulet Capital Partners for their significant support as an investor
over the last several years. "
The Company expects to close the transaction by the end of 2020,
subject to the satisfaction of customary closing conditions.

Aphena Pharma Completes
$7M Expansion
Aphena Pharma Solutions has completed its $7 million facility
expansion and renovation in Easton, Maryland. The newly renovated,
30,000-square-foot facility and three large, high-end blending suites
are open for new pharmaceutical business. Aphena's Maryland
campus supports liquids, creams, gels and suspensions.
While two new blending suites were originally planned, the
company expanded that number to three. Housed in those three
suites are two brand-new Feldmeier 1,000-gallon mixing tanks and
a sister 100-gallon tank, which offer center agitation mixing and
dual alternate directional side sweeps for scale-up and registration
batches. In addition, the tanks are jacketed for heat and chilling and
are pressurized for powder mixing.
" Adding these tanks and new capabilities will allow Aphena to increase
capacity levels and handle 90% of the liquid-based pharmaceutical
products on the market today, " said Eric Allen, Aphena's EVP of Sales.
" The smaller 100-gallon tank is 1/10 scale, making submission batches
easy to scale per FDA guidelines. "
" The recent expansions at our Maryland and Tennessee facilities
position Aphena to support significant future growth, " said Aphena
CEO Shawn Reilley. " We are committed to investing aggressively as
needed to ensure that Aphena remains an industry leader in terms of
innovation and turnaround time. "
| 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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