Page 145 - CW E-Magazine (26-3-2024)

Pharmaceuticals Pharmaceuticals

BIOPHARMA BUSINESS BOOSTING BUSINESS
Syngene biologics facility to be operational for DKSH signs exclusive distribution agreement with

US and European customers from mid-year Southern RNA in India

At DCAT 2024 global bio/pharma- located nearby offering clients a seam- DKSH’s Business Unit Perfor- innovation. Our suite of rea-
ceutical manufacturing forum, Syn- less transition from discovery biology mance Materials, a leading distributor gents and services, tailored for
gene International, a global contract services into clinical and commercial of specialty chemicals and ingredi- RNA-based therapeutics and
research, development and manufac- manufacturing. The company also ents, will provide business develop- vaccines, including our fl ag-
turing organization (CRDMO), will has a microbial cGMP facility and a ment, marketing, sales, logistics, and ship mRNA capping reagent,
announce that its newly upgraded bio- mammalian cell manufacturing facility to distribution services for Southern Co Cap A, aims to empower
logics facility – Unit 3 – would be ope- extend end-to-end Chemistry, Man- RNA’s cutting-edge messenger ribo- our clients to pioneer the next
rational for clinical and commercial ufacturing and Control (CMC) deve- nucleic acid (mRNA) raw material wave of medicinal break-
supply in the second half of 2024. lopment solutions for its global clients. and vaccines in India. mRNA is a type throughs with the highest
Syngene has further expansion plans for of single-stranded RNA involved in quality reagents. We eagerly
The facility will be available for two additional vial fi lling isolator lines Downstream processing is suppor- protein synthesis. The partnership anticipate the advancements
biotech and pharma customers seek- with capacity for 600 vials/minute and ted by chromatography systems with was unveiled at the recent BioAsia this partnership will bring to
ing drug substance and drug product 100 vials/minute respectively and drug capacity of 600-2000-lph enabling the 2024 conference. commercial and technical teams, as the forefront of healthcare and
contract manufacturing. The drug sub- substance expansion into perfusion cell purifi cation and isolation of target mole- well as strong capabilities in logistics medicine.”
stance capacity includes two produc- culture processing. cules from complex mixtures. The Southern RNA is an Australia- and value-added services, including
tion suites with fi ve 2-kl single-use integration of chromatography systems based company recognized as an technical and regulatory support. Mr. Vishal Jawale, Managing
bioreactors each, for a total capacity of “We see interest not only from streamlines the purifi cation processes expert in developing and manufactur- Director and Country Management
20-kl. The facility also includes two existing partners looking to move and enhances the overall effi ciency of ing pharmaceutical ingredients. The Dr. Romain Tropée, Head of Head, DKSH India, commented:
high-speed vial fi lling lines capable of innovative biologics into clinical and biologics manufacturing. Additionally, company specializes in producing Science and Technology, Southern “We are very pleased to sign a distri-
producing up to 1-million vials per day. commercial manufacturing, but also to meet the growing demand for nucleic acid products that support the RNA, commented: “We are thrilled bution agreement with Southern RNA
ranging from 1-100 ml fi ll volumes. In from new biotechs and big pharma protein concentration and diafi ltration, clinical development of therapeutic to announce our strategic partnership in India. Our deep market insights and
addition to the production capacity, the companies. In particular, there is Syngene has invested in automated tan- products. with DKSH, marking a signifi cant broad range of services in the region
site has a development suite for clinical demand from commercial clients looking gential fl ow fi ltration (TFF) systems step towards Southern RNA’s entry will enable us to increase growth for
supply of drug substance equipped with for immediately available capacity. to facilitate the concentration and dia- DKSH has been entrusted by into the Indian pharmaceutical mar- Southern RNA’s mRNA raw materials
a 500-l single-use bioreactor. With US FDA and EMA approvals fi ltration of biologics, maximizing the Southern RNA to grow their pharma- ket. This collaboration, unveiled at and drug substances as well as gene-
in place, Unit 3 is a very attractive yield and quality of fi nal products, as ceutical business in India. This is BioAsia 2024, embodies the immense rate more value for our wide customer
The facility triples Syngene’s bio option, so we are preparing for a busy well supporting perfusion manufactur- thanks to DKSH’s extensive distri- potential for cooperation between base by using traditional and digital
manufacturing capacity and adds to its week at DCAT,” commented Mr. Jona- ing. In total Unit 3 will have around 100 bution network, highly specialized Australia and India in pharmaceutical distribution and marketing channels.”
existing commercial manufacturing site than Hunt, MD & CEO, Syngene staff for Quality Assurance and Manu-
in Bangalore – BMP 1 – which has been International Ltd. The $98-mn manu- facturing, part of Syngene’s 600-strong
approved by the US FDA (with no 483 facturing site is integrated with other team across its biologics manufacturing US FDA raises a concern after Lupin’s Aurangabad
observations) and EMA, as well as a biologics capabilities in Bangalore, services and supporting specialist func-
PROTAC research site in Hyderabad. including around 170 R&D scientists tions. unit inspection

MILESTONE Pharma major Lupin Ltd. has dis- in its ability to address the concerns
Nirma completes acquisition of 75% stake closed that its manufacturing facility raised by the FDA promptly.
located in Aurangabad underwent
“We are confi dent of addressing
in Glenmark Life Sciences inspection by the US FDA from March the concern raised by the US FDA and
6-15, 2024, and the inspection con-
cluded with the issuance of a Form- will resolve the same at the earliest.
Indian conglomerate Nirma has The acquisition strengthens shares, making it the promoter of 483, highlighting one observation. We uphold quality and compliance
completed the acquisition of a 75% Nirma’s presence in the pharmaceuticals GLS. The acquisition involved 75% with utmost importance and are com-
stake in Glenmark Life Sciences (GLS), and life sciences sector. Under the of the current issued and paid-up While the specifi cs of the observa- mitted to comply with CGMP quality
a manufacturer of active pharmaceutical terms of the share purchase agree- equity share capital of GLS from tion were not detailed in the announce- standards across all our facilities,”
ingredients (APIs). ment, Nirma acquired 91.9-mn equity Glenmark Pharmaceuticals. ment, Lupin expressed confi dence Lupin said.

144 Chemical Weekly March 26, 2024 Chemical Weekly March 26, 2024 145

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