WuXi STA has made no secret of its plans for rapid expansion, previously telling in-PharmaTechnologist that its business strategy involves building one active pharmaceutical ingredient plant every year​.

The company recently had positive news with the announcement that the European Medicines Agency (EMA) had approved its drug product manufacturing facility in Shanghai at the first time of asking.

The approval follows on from a similar decision by the US Food and Drug Administration (FDA) for its Changzhou API facility in 2018​. In addition, WuXi STA became the first company​ to receive an approval from the Chinese government under revised policies for contract manufacturing organisations (CMOs).

To discuss the company’s approach in greater detail and how it plans to continue its growth in, and outside of, the Chinese market, in-PharmaTechnologist (IPT​) spoke to Mei Hao (MH​), VP of quality assurance at WuXi STA.

IPT: You previously referred to the Shanghai facility passing GMP inspection by European authorities as a ‘key milestone’ – could you expand upon this?

Mei Hao Gray Background

Mei Hao, VP of QA at WuXi STA

MH:​ What we are talking about here, in simple terms, is having all CMC [chemistry, manufacturing, and controls] services – whether for API development and commercial supply or clinical trial supply and finished product – all within close geographic proximity.

So, this global inspection for our newly built GMP drug product site in Shanghai is another significant milestone in our integrated CMC platform, and further evidence of the robust global quality systems in place at every site.

IPT: How significant is the European market to WuXi STA?

MH: ​It is home to the world’s second largest advanced economy, the EU, and as such is still a prime target for NCE [new chemical entity] sales by big pharma. With our new site approved for commercial production, we can supply commercial products into all EU countries for clients. In addition, some of the world’s largest pharma companies are based here, as well as many of our strategic partners.

IPT: Are there any plans to expand WuXi STA’s physical footprint into Europe itself?

MH: ​We are always looking for new technologies anywhere in the world that will increase our capabilities to clients. A good example is the recent partnership agreement we announced with Biolingus – a Swiss company – to provide sublingual technology in the CDMO space. But, in addition, we also plan to continue expanding capacity at our geographically integrated sites in China.

IPT: Could you outline the importance of being able to offer both API and finished drug product services?

MH: ​Geographically integrated CMC services offer intrinsic benefits, in terms of speed and efficiency. The benefits can be realised in all stages of development, from early phase clinical study, where overall speed is paramount, to late phase development, where efficiency in material transfer can be instrumental expediting production timelines.

Taking the lifespan of development as an example, by being geographically integrated we have the capability to significantly reduce the overall time to market for a customer.

 IPT: On the API side of the business, during a previous interview, a WuXi STA representative told us that the plan was to add one new plant each year – is this still the plan for growth?

MH: ​Yes, the construction of additional API plants are on schedule at our Changzhou integrated process R&D and manufacturing site. In 2019, we will open a dedicated oligonucleotide gram to kilogram scale manufacturing plant. We will also complete another multi-function plant in Changzhou by the fourth quarter of 2019, equipped with large scale preparative HPLC capability as well as larger scale (250 L to 1000 L) high potency cGMP manufacturing capability, which will supplement our Jinshan high potency kilo lab. 

IPT: More broadly, what are WuXi STA’s ambitions for its place in the global CDMO market in the years to come?

MH: ​In 2018, WuXi STA expanded modalities of molecules that we are capable of supporting – adding oligonucleotides and peptides – enabling more innovative companies to reach patients with promising targets. We will increase our capability in these areas throughout 2019 and 2020.

In addition, we expanded our global regulatory affairs CMC team to support our clients’ dual Western and China filings. We will continue to expand our API process research and development, as well as manufacturing capacities at our Changzhou and Jinshan, China facilities. Our goal is to provide the most comprehensive CMC platform from preclinical to commercial, providing partners’ access to the widest possible market in the shortest possible time.

Mei Hao holds a master’s degree Chemical Engineering. As VP of quality assurance at STA Pharmaceutical, a WuXi AppTec company, Hao is responsible for the quality system and regulatory compliance across STA’s global GMP sites.

Kategorie: Processing