Vetter Supports Chinese Pharma Companies' Global Expansion with 'DS in China, DP Abroad' Strategy

Aseptic filling of sterile formulations is the critical final step in biopharmaceutical manufacturing, involving multiple automated processes such as bottle washing, filling, stoppering and capping, and packaging. The entire process must strictly adhere to current Good Manufacturing Practice (cGMP) regulations and standards. A high-standard aseptic assurance system permeates this highly complex continuous production process.

Global regulatory authorities have implemented extremely stringent requirements for the production and quality control of sterile pharmaceutical products. For instance, when approving ophthalmic drugs, the U.S. FDA conducts particularly rigorous reviews of the Chemistry, Manufacturing, and Controls (CMC) section to ensure the safety and efficacy of the products.

In May last year, Regeneron’s application for the high-dose 8 mg formulation of Eylea received a Complete Response Letter (CRL) from the FDA. According to the company’s announcement, the FDA identified manufacturing issues at the third-party drug filling facility for Eylea, which interrupted the approval process. Affected by this news, Regeneron’s stock price fell 8.7% before the market close on that day. The 8 mg formulation of Eylea was not approved for marketing until August 2023.

In fact, this rejection was due to compliance issues, with no concerns regarding clinical efficacy or safety, trial design, labeling, or active pharmaceutical ingredient (API) manufacturing. It is highly regrettable that a six-month window of opportunity was missed due to the fill-finish manufacturer’s compliance issues, which may lead to intensified market competition and greater losses in the future.

The value of aseptic filling is now evident. So, what exactly is this niche sector?

If the biopharmaceutical manufacturing process is divided into two parts, one is the production of drug substance (DS), and the other is the production of drug product (DP). While the focus of DS production lies in cost reduction and efficiency improvement, DP production places greater emphasis on risk mitigation and avoidance of potential risks. This is because any issues arising during DP production may not only lead to drug recalls but also expose manufacturers to substantial liability claims.

However, aseptic filling is an industry that demands exceptionally high standards in organizational coordination, quality assurance, and regulatory compliance, with the ultimate goal of ensuring clients’ products successfully reach the market on their first attempt. Therefore, when selecting partners, pharmaceutical companies will prioritize CDMOs with mature platform systems and extensive practical experience as key evaluation criteria.

Vetter Headquarters

Vetter is a global leader in high-end injectable drug CDMO, with 74 years of development history and over 40 years of experience in sterile filling and packaging. Currently, Vetter has production bases in Germany, Austria, and the United States, and has established sales offices in the Asia-Pacific markets such as Japan, China, South Korea, and Singapore. The company currently employs more than 6,300 people, with revenues exceeding €1 billion in DP filling and product packaging.

Vetter’s service portfolio encompasses the sterile filling and packaging of injectables, including syringes, dual-chamber injection systems, cartridges, and vials. More than 80% of Vetter’s active client projects involve biologics, with over 200 ongoing programs spanning from preclinical development through Phase III clinical trials. Historically, Vetter’s product quality has consistently passed dozens of annual inspections by global regulatory authorities—including the FDA, EMA, and NMPA—without any deficiencies. To date, Vetter has supported more than 110 commercialized pharmaceutical products approved for market by the FDA and EMA.

Filled Cartridges

Through innovative solutions, Vetter collaborates with customers to develop pre-filled syringe and auto-injector pen delivery systems, continuously enhancing patient safety, comfort, and adherence. The company also places significant emphasis on social responsibility, including environmental protection and sustainability. Vetter is a member of the United Nations Global Compact, has received the CDMO Leadership Award multiple times, and has been repeatedly recognized as one of the best-managed companies.

Vetter’s story began with deep insight into and dedicated cultivation of niche markets.

In 1950, Vetter was founded in Ravensburg, Germany. As a family-owned business specializing in CDMO services for the pharmaceutical industry, Vetter has demonstrated exceptional expertise in the development, manufacturing, assembly, and packaging of injectables, cementing its position as a global leader in this niche sector.

Automatic Loading for Lyophilizer

As its business continues to grow and international cooperation deepens, Vetter has expanded its global market presence by establishing its Asia-Pacific headquarters in Singapore and setting up branches in Tokyo, Japan, and Incheon, South Korea, bringing German precision engineering and expertise to every corner of the world.

The expansion into the Chinese market is undoubtedly a significant milestone in Vetter Pharma’s global journey.

In recent years, China has become a key battleground for the pharmaceutical and healthcare industry, driven by its large population base, rapid economic development, and growing medical demands. Meanwhile, an increasing number of Chinese pharmaceutical companies have begun to prioritize overseas market expansion as a core strategic direction. Against this backdrop, Vetter recognizes that providing CDMO services to support the global expansion of Chinese pharmaceutical companies will be a crucial next step in its development strategy.

Daniel Zhang Deliang, Head of Marketing for Vetter China, stated: “With the accelerating growth of China’s biopharmaceutical market and the increasing willingness of pharmaceutical companies to expand globally, demand for mature sterile fill-and-finish CDMO services is continuously rising. As an expert in biopharmaceutical fill-and-finish, Vetter has a pipeline in which over 80% consists of biopharmaceutical products, including nucleic acid-based therapies, peptides, monoclonal and polyclonal antibodies, as well as biologics such as hormones, proteins, and fusion proteins. This portfolio aligns closely with China’s rapidly growing market.”

Lyophilized Dual-Chamber Syringe

In 2021, Vetter established an office in Shanghai. Prior to this, Vetter had already successfully facilitated the market launch of more than 20 drugs in China and participated in over 80 clinical trial projects, including blockbuster drugs such as Humira, aflibercept, and dulaglutide.

Having gained an in-depth understanding of the characteristics and demands of the Chinese market, Vetter’s next strategic step is to provide professional CDMO services to Chinese pharmaceutical companies seeking to expand into international markets. These services encompass not only sterile filling and packaging but also cover the entire product lifecycle from early preclinical stages through full-scale commercial production, thereby supporting clients in process development as well as the manufacturing of clinical trial materials and commercial supplies.

Leveraging its extensive international service capabilities and experience, Vetter provides Chinese pharmaceutical companies with seamless end-to-end solutions from local markets to the global stage, helping them secure a competitive position in the worldwide pharmaceutical industry.

According to Jason Zhong Lei, Head of Business Development for Vetter in Asia, the combination of manufacturing drug substance in China and completing sterile filling of finished dosage forms abroad offers indisputable advantages amid the prevailing trend of Chinese pharmaceutical companies expanding into global markets.

First, bulk drug substance production and drug product formulation are often asynchronous; the former involves multiple production batches and may take several weeks, whereas the latter can be completed within two to three days. Therefore, separating these two stages can significantly enhance capacity utilization.

Secondly, producing drug substance in China offers cost advantages, while conducting formulation manufacturing and fill-finish operations abroad—particularly in countries with mature technologies and well-established regulatory systems—can further enhance the success rate of the project’s CMC development.

Finally, Vetter’s strong track record of international regulatory compliance, extensive knowledge of pharmaceutical regulations, and in-depth understanding of global regulatory requirements can provide significant support to Chinese enterprises in preparing the regulatory documentation required for clinical research and sales registration approvals.

Cleanroom Environmental Sampling

Vetter’s advocated concept of “conducting drug substance (DS) manufacturing in China and drug product (DP) manufacturing abroad” represents not only a shift in production models but also an upgrade in strategic thinking, helping Chinese pharmaceutical companies find their niche in the global pharmaceutical industry chain, optimize resource allocation, and enhance international competitiveness.

“This combination represents the optimal balance of cost, compliance, and quality, but this concept has not yet gained widespread adoption in China,” said Zhang Deliang.

Vetter aims to do more than just provide CDMO services for Chinese pharmaceutical companies expanding overseas; it seeks to embed this philosophy into their development strategies, helping them enhance product quality and accelerate their internationalization.

Currently, the wave of Chinese biopharmaceutical companies expanding overseas is surging, with more Chinese medical innovation enterprises participating in global competition and achieving a transition from merely providing Chinese products to exporting comprehensive Chinese solutions. According to data from PharmaCube, nearly 70 license-out deals for innovative drugs were completed in China in 2023, with the total disclosed transaction value exceeding $35 billion, setting a new historical high.

Undoubtedly, China’s pharmaceutical industry is entering an era of great exploration, with numerous market opportunities awaiting discovery; yet on the other side of these opportunities lie significant challenges.

According to previous research by VCBeat, the biggest challenge facing Chinese pharmaceutical companies in their global expansion is “information asymmetry.” Given the varying industrial, political, and economic environments across different regions worldwide, decisions on where and how to expand internationally require careful consideration. Consequently, there is currently a strong demand for a “guide” to navigate this process.

Product Visual Inspection

To meet the needs of Chinese pharmaceutical companies expanding globally, Vetter offers one-stop services from product development to market access.

First, Vetter’s technological advantages in the field of sterile filling can effectively ensure drug quality and improve production efficiency. Meanwhile, Vetter’s experience and resources in global drug market launches can also reduce the risks and uncertainties faced by Chinese pharmaceutical companies during their exploration of international markets.

This provides Chinese pharmaceutical companies with a powerful partner, enabling them to focus more on product development and market strategies, thereby ensuring the competitiveness of their products in the international market.

“If Vetter serves as the CDMO for DP manufacturing, the potential licensees of the company are very likely already our clients. This means that the future international market layout and operations of its projects will proceed very smoothly, as the entire system is fully consistent with that of future buyers, potentially allowing for direct market launch without any modifications,” said Zhong Lei.

Looking to the future, as the demand for Chinese pharmaceutical companies to expand overseas continues to grow, Vetter will partner with them, leveraging its world-leading sterile fill-finish expertise, extensive resources accumulated in international markets over many years, and a scientifically rigorous approach to support and safeguard their global expansion.

Note: The data in this article are sourced from the CDE’s Listed Drug Information and the Drug Clinical Trial Registration and Information Publicity Platform.