Prestige Biologics enters into MoU with Aurigene Pharmaceutical Services Limited to explore collaboration in the global biologics CDMO marketPrestige Biologics, a Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceuticals, announced the establishment of a strategic partnership with Aurigene Pharmaceutical Services Limited (APSL), a wholly owned step-down subsidiary company of Dr. Reddy’s Laboratories Limited, through the signing of a non-binding Memorandum of Understanding (MoU). The MoU, which is subject to a Definitive Agreement, will oversee collaborative efforts between Prestige Biologics and APSL to bring in a comprehensive set of services and capabilities towards meeting the CDMO needs of biologics-focused companies. “We are delighted to announce our strategic partnership with Aurigene Pharmaceutical Services Limited,” stated Duk Hoon Hyun, CEO of Prestige Biologics. “Prestige Biologics’ global prominence in the CDMO market, coupled with Aurigene’s pharmaceutical expertise in R&D services, will create an end-to-end service capability in the Biologics CRDMO segment through this collaboration, offering cell line development to large-scale manufacturing services for global Biologics customers.”Aurigene Pharmaceutical Services Limited is a Contract Research, Development and Manufacturing Organization (CRDMO) with end-to-end capabilities across drug discovery, development, and manufacturing of small and large molecules. Dr. Reddy’s Laboratories Limited, the parent company of APSL, is a global pharmaceutical company, founded in 1984, with four decades of expertise in pharmaceutical development, and a global commercial network. Prestige Biologics operates production facilities based in South Korea, with a manufacturing capacity of 154,000 litres, making Prestige Biologics one of the top 10 global CDMO companies working with animal cell culture.

On Friday, June 23rd, Prestige Biologics welcomed guests. As part of the Global Bio Human Resource Training Hub Program supported by the World Health Organization (WHO), more than 60 biopharmaceutical industry experts from developing countries visited Prestige Biologics Osong Campus.This exchange program for technical education, conducted in association with WHO from June 19th to 30th, aims to develop the capabilities of professional manufacturing personnel who have been engaged in the biopharmaceutical industry for more than 6 years in Low, Middle Income Countries (LMIC). will contribute to strengthening It is expected to increase understanding of Korea's outstanding biopharmaceutical development and production capabilities and help develop the biopharmaceutical industry in low- and middle-income countries. Within the biopharmaceutical industry for the past few years, there has been a lively discussion on bioequity, which is the free access to the benefits of biopharmaceuticals regardless of national or individual income levels. In order to achieve meaningful results in Bio Equity, which is set as an important future goal by the bio industry and medical policy organizations in each region, it is necessary to secure a stable supply chain, biopharmaceutical production capacity, and various competitions among biopharmaceuticals. In this environment, it is also important that biopharmaceutical CDMO service companies should make efforts to improve production efficiency and continuously develop production technologies that provide higher yields.Various questions and answers are being conducted with the participants through the comprehensive control monitor, which shows the status of the entire production facility.The World Health Organization (WHO) and the Ministry of Health and Welfare of the Republic of Korea are operating the first global biomanpower training hub (GTH-B) to build vaccine and biopharmaceutical manufacturing capabilities in LMIC countries. In the global biopharmaceutical industry, humans contribute to life in many aspects. This is not limited to the development and production of biopharmaceuticals, but it is necessary to consider bio research and new drugs that are continuously entering the stage of commercial production, where regulations and systems in major countries are rapidly changing. In terms of institutional aspects, Bio Equity also has an aspect that can be supplied to patients more quickly and at the right time when policy-making institutions and academics in major countries have sufficient understanding. In order to strengthen this understanding and expand greater consensus, this event in collaboration between WHO and the Korean Ministry of Health and Welfare has a very important meaning.Prestige Biologics' main production capacity and secured production facilities are introduced to public officials from LMIC countries, academia and industry participants.Prestige Biologics introduced its production facilities, QC and PD facilities of its own production facilities, Plants 1 and 4, to officials from the Ministry of Food and Drug Safety, pharmaceutical companies, and universities in developing countries, and explained the production process. In particular, Plant 1 showed great interest in a full single-use system based on a single-use bioreactor with a capacity of 2,000 liters. Not only did it flexibly respond to customer needs with easy equipment arrangement or process and product changes, but also the fact that contamination was minimized through the use of disposable bags attracted the attention of the participants. Factory 4 introduced ‘ALITA Smart BioFactory’, which combines single use and stainless steel, focusing on the digital automation of the production process.Participants showing high interest in the description of the key analytical tests for production.In order to respond to the demand for flexibility in production capacity and diversification of the biopharmaceutical industry that is currently underway, Prestige BioLogics has optimized and strategically optimized four biopharmaceutical production plants in two campuses within the Osong bio cluster. All facilities are strategically organized around a 2,000 liter single use bioreactor. The 2,000 liter single-use bioreactor, which was strategically adopted as a production system that can respond most flexibly to the needs of commercial production of various scales, is now also a production facility strategy that is being reviewed as important by other countries and companies. Prestige Biologics has already successfully carried out process development and commercial production of biosimilars and new antibody drugs using the leading production system already secured. Through this, we are accumulating biopharmaceutical production technology through 2,000 liter single-use bioreactor and hybrid system, and making continuous improvements.In the ‘2023 Vaccine/Biopharmaceutical Quality Management Basic Training (GxP Course)’, participants listen to the company introduction and take a commemorative photo (CEO in the middle).An official from a major pharmaceutical company who participated in the tour said, “The tour to the manufacturing process of Prestige Biologics’ state-of-the-art facilities was an important time to gain insights on the overall biopharmaceutical production process. It was a valuable opportunity to see and learn not only the GMP of Korean government agencies, but also the GMP approval for biopharmaceutical manufacturing facilities in EU countries.” We will take the lead in improving biopharmaceutical production capacity.”

From today, May 31st, to June 1st, the European Biomanufacturing Summit is taking place in Berlin, Germany. This event brings together key department representatives from global companies such as Bayer, AstraZeneca, Boehringer Ingelheim, Ipsen, Amgen, Abbie, and others to discuss and collaborate on biosimilars and biopharmaceuticals with a focus on Europe, following a previous event held in the United States.The Global Sales Team at Prestige Biologics is sensing a vibrant market atmosphere in Europe that is becoming more active than before. With the end of the COVID-19 pandemic, many global pharmaceutical companies are now engaging in discussions about stable supply chains for the development, production, and distribution of new stages of biopharmaceuticals. Both the U.S. and European biopharmaceutical markets are actively preparing for a new future.Various global companies are concerned about rapid production expansion of pharmaceuticals and actively exploring potential CDMO partners who can flexibly respond to these demands. In contrast to 2022, the biopharmaceutical market in 2023 is undergoing significant changes. Instead of previous expansion strategies involving M&A or direct facility expansion, companies are now more meaningfully evaluating collaborations and partnerships with diverse entities.By leveraging customer-centric facilities and technical service capabilities, Prestige Biologics is expanding touchpoints with potential future customers and deepening relationships.(Prestige Biologics Global Sales Division, Berlin)Prestige Biologics has secured a significant track record over the past few years. It has sufficiently demonstrated its production capabilities for monoclonal antibody biosimilars through its pipeline, such as HD201 and HD204, and has simultaneously proven its capabilities in the development and production of novel antibodies. Additionally, Prestige Biologics' Alita Smart BioFactory, a technological model for bioprocessing, is being recognized for its practical application and improvements in productivity and efficiency.The Alita Smart BioFactory technology from Prestige Biologics is an advanced technological model. It facilitates the rapid market launch of customer products. Particularly, it explains the ability to scale up to 2,000 liters and then scale out by connecting 2,000L single-use bioreactors, providing ideal flexibility to meet evolving customer demands. European customers also understand the challenges of responding to diverse demands with fixed stainless-steel bioreactors larger than 10,000 liters. Therefore, the validated production capacity of Prestige Biologics, which rapidly expands production capacity with a focus on 2,000L single-use bioreactors, is gaining more attention. Global companies are expected to show interest in Prestige Biologics' choices and focus, which consider potential future diversification of customer demands as important decisions, not just changes in technology.During the first half of 2023, Prestige Biologics has increased its interactions with potential customers by several times compared to the previous year. Extending these efforts, it is preparing a dedicated booth and participating in the BIO USA event to be held in Boston from June 5th to June 8th.Prestige Biopharma plans to introduce its pipeline held by the group and discover possibilities for deeper collaborations. It also plans to expand touchpoints with global customers and pursue partnerships that foster deeper relationships.With its accumulated process technology development capabilities, experience and technical expertise in improving production efficiency, and the ability to support efficient collaboration with customers, Prestige Biologics aims to be a unique partner that leads customers' major pipelines to commercial production.Prestige Biologics strives to earn trust from customers as an extension of their team, contributing to human life and growing as a pivotal entity.

Prestige Biologics participates in the BioProcess International 2022 to be held from September 27 to 30 in Boston, USA.BioProcess International is a global bioprocessing event covering novel science across all phases of bioprocessing for biologic. Its agenda includes manufacturing strategy, upstream and downstream processing optimization, and quality, providing the opportunity of learning the latest practice and building network.At the event, Prestige Biologics operates its own dedicated booth, featuring the company’s CDEMO service, top-notch facilities and equipment, and proprietary technology ‘ALITA Smart BioFactory’ to attract global biopharmaceuticals and target potential clients.