Pharmaceutical Outsourcing Q2 2024 - 40

INDUSTRY NEWS
that could produce it, " said Dr. Sangkyun Lee, in charge of research and
development at Sumagen. " With Sumagen's know-how and Naobios'
experience, I am confident that we will be successful in clinical sample
production. I am highly encouraged by the resumption of the project
and the partnership with Naobios. "
" We are honored that Sumagen trusts us to develop and manufacture
its HIV vaccine candidate, which has the potential to be the first HIV-1
vaccine to achieve market authorization, " said Eric Le Forestier, general
manager of Naobios. " With our years of expertise in the development
and production of viral vaccines, we are confident that we can support
Sumagen through the next stages of its clinical development. "
Kindeva Drug Delivery and Syntegon
Install first Versynta microBatch in
North America
Syntegon announced the sale of its newly developed Versynta
microBatch production cell to its first U.S. customer. Kindeva Drug
Delivery will use Versynta microBatch to further expand its suite
of aseptic fill-finish contract development and manufacturing
(CDMO) capabilities meeting the latest global pharmaceutical
regulations and trends. Kindeva is a leading global CDMO that
develops and manufactures products across a range of routes of
administration including injectable, pulmonary, nasal, transdermal,
and intradermal delivery.
Robotic competence on the smallest scale
" Syntegon's Versynta microBatch enables Kindeva to offer significant
flexibility to our customers by rapidly adding clinical development and
small-scale commercial GMP filling capacity, which complements our
large-scale vial, syringe, and cartridge isolator filling lines. Syntegon's
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technology expertise is unquestionable, but it is their ability to partner
that has really made this an ideal collaboration for Kindeva, " said
David Stevens, Kindeva Global Chief Commercial Officer. " Versynta
microBatch provides agility, best-in-class automation, and sterility
assurance that meets our patient safety and regulatory compliance
objectives which we believe sets the standard for CDMOs. "
The fully automated production cell is specifically designed for very
small batches of highly potent and often highly costly drugs, for
instance in the field of cell and gene therapy, where maximum product
yields are key. Versynta microBatch fills between 120 and 500 syringes,
cartridges, and vials made of glass or plastic per hour with virtually no
product loss. Fast batch-to-batch changeovers ensure that efficiency
remains high without compromising on flexibility.
Prepared for regulatory challenges
As Kindeva serves a global client base, compliance with local
regulations of its target markets is paramount. For Europe, this includes
the new EU GMP Annex 1, which is setting new benchmarks in aseptic
fill-finish operations. Syntegon developed Versynta microBatch with
these requirements in mind: the gloveless isolator with integrated
air treatment significantly reduces operator intervention and the risk
of contamination. The 100 percent in-process control ensures high
quality. Five integrated inline inspection systems provide special
safety, while optional network cameras ensure continuous monitoring
of production in the isolator via remote access.
" During my 35 years of working in the pharmaceutical packaging and
processing business, it is rare to experience the partnership Syntegon
and Kindeva enjoy. With our joint successes, their experience, and
high level of technical capabilities, Kindeva is a perfect partner for
our technology-leading Versynta microBatch, " said Kerry Fillmore,
Managing Director of Syntegon Pharma Technology in North America.
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Pharmaceutical Outsourcing Q2 2024

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