ShangPharma opens pilot plant in Shanghai
For pharma development and cGMP manufacturing
The new multi-purpose pharmaceutical development and cGMP manufacturing facility will allow ShangPharma to support its clients Phase II and Phase III trials, expanding its service offering to include process and formulation r&d, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.
Previously the CRO/CMO provided clients with materials for early discovery and GLP toxicology testing and Phase I clinical trials.
ShangPharma said it might further expand its manufacturing facilities if there is demand for commercial manufacturing of FDA- or EMEA-approved drugs.
The Fengxian facility will operate as a wholly owned subsidiary of the company under the name China Gateway Pharmaceutical Development Co. It includes a pilot plant that supports six separate bays with reactor capacities ranging from 200 to 3,000 litres and other speciality bays with reactor capacities ranging from 50 to 2000 litres for high temperature, cryogenics, highly toxic and pressurised reactions, including hydrogenation.
The company said there are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-lab suites for bothnon-cGMP and cGMP manufacturing, as well as a large r&d laboratory for analytical, formulation and process development activities.
In addition, there are separate buildings for utilities, materials management, warehouse storage and waste water treatment with room for further expansion to support commercial manufacturing activities.
Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department will ensure that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed, the firm said.
You may also like
Ingredients
Safe and accurate flow measurement for pharmaceutical production
Read moreOval Gear (OG) meters from Titan Enterprises, fitted with a Namur sensor, provide consistent, accurate measurement across a wide range of liquids, from low-viscosity solvents to more viscous pharmaceutical ingredients
Trending Articles
-
You need to be a subscriber to read this article.
Click here to find out more.
You may also like
You need to be a subscriber to read this article.
Click here to find out more.
Click here to find out more.
Research & Development
The path to commercial allogeneic iPSC therapies
The cell therapy sector is currently shifting from patient-specific autologous treatments toward off-the-shelf allogeneic cell therapies. Although this transition is helping to democratise access to treatments, it introduces several challenges in terms of controlling complex biology at a commercial scale
Manufacturing
Safety in pharmaceutical manufacturing: why a trusted partner makes all the difference
By taking a three-tiered approach to protecting patients and personnel and ensuring plant compliance, GEA adopts a consultative approach to helping its customers navigate the responsibilities of pharmaceutical manufacturing safety with confidence
Research & Development
The IND advantage: why early derisking is a strategic imperative for complex biologics
As biologics grow more complex, early identification and the mitigation of manufacturability, stability and immunogenicity risks have become the critical factor separating programmes that reach IND on time from those that don't, says Yvette Stallwood, Head of Early Development Services at Lonza
Research & Development
Stipple Bio enters into multi-target license agreement with Lonza to advance precision oncology ADC therapies
Stipple Bio’s Pointillist Platform identifies tumour-specific cell surface epitopes that, when combined with Lonza’s clinically validated ADC platform, may enable first-in-class and best-in-class ADC oncology medicines such as STP-100
Manufacturing
Aragen to manufacture Renaissance Pharma’s FDA Fast Track mAb as part of ongoing strategic collaboration
CRDMO successfully scaled and transferred Renaissance Pharma’s lead candidate, Daretabart a humanised monoclonal antibody targeting GD2 for high-risk neuroblastoma, in just 9 months