News For The Biologics Industry
Break the CFDA Code:Summary of Latest Changes and Impacts in China Regulatory Policies
The Chinese government (State Council) announced on Aug. 18th, 2015 to implement comprehensive reforms to China FDA (CFDA) review and approval system for drugs and medical devices. These reforms will have a profound impact on the entire health care industry in China, affecting both Chinese and foreign companies pursuing development and registration of drugs and medical devices in China. This webinar is designed to go through these reforms with our ex-China audience, analyzing and discussing potential implications and business impact to foreign companies, in order to help our clients to develop up-to-date and optimized business strategy and plan under the new regulatory environment in China. (Learn more or to register)
Unknown Compounds in Extractable / Leachable Studies Considered Unacceptable by Regulatory Bodies
Over the past year, regulatory agencies have been placing increased emphasis on materials characterization of medical devices. In particular, they are looking to see robust extractable/leachable studies for most devices. Global regulatory agencies are insisting more than ever that device manufacturers identify and understand the toxicological impact of all of the chemicals in their products. The presence of unknowns sets off regulatory red flags. Interestingly, without an adequate study design, unknowns can be found even in common materials like polymers and hydrophobic coatings.
Unfortunately when unknowns occur, manufacturers are faced with tough choices. They are forced to either repeat testing using much more rigorous approaches to identify the unknowns, or consider the product to have the highest risk categories. Agencies have indicated that “unknowns” must be considered as carcinogenic and/or genotoxic unless the biological testing has demonstrated otherwise. This problem doesn’t occur only during development, but can occur when switching suppliers. Even though a material is considered well established, that doesn’t mean that each vendor uses the exact same processing and additives. What might have been considered very routine testing can rapidly become much more troublesome if the right methods and identifications aren’t made.
TIPS FOR SUCCESS:
Test your product using your processes
Ask your vendor or chemistry department about the number of unknowns they typically see in extractables/leachables studies. They should be able to identify over 99% of chemicals identified on a routine basis.
Complete a toxicological risk assessment of all extracted and leached materials to support your testing and safety claims.
An Interview with Dr. Jiawen Han:
Developing a Novel ADC for Global Market via Innovative Three-party Collaboration
Recently, Dr. Jiawen Han, Vice President of ADC Technology at WuXi Biologics, presented at the 1st DIA China Drug Discovery and Innovation Conference. His presentation provided a brief history of antibody drug conjugates (ADCs) as a therapeutic class, the challenges of designing and developing these complex drugs, new technologies available to drug developers and finished with a successful case study describing a three-party collaboration model to develop a novel ADC for global clinical trials. This week we sat down with Dr. Han to provide a synopsis of his talk and discussion on the various challenges and approaches to developing novel ADCs for the global healthcare markets and to gain further insight on the case study he presented. (Read more)
New Cell Therapy Facility Opens in Philadelphia
Construction has been completed on WuXi AppTec’s second cell therapy manufacturing facility in Philadelphia, adding 55,000 square feet of cGMP manufacturing and support space. The new facility will accommodate both planar and microcarrier cell culture systems and — featuring flexible clean room design and single-use disposable systems — will offer exceptionally fast adaptation and capacity scale-up to help our partners meet the rapidly growing demands of clinical and commercial supply. Located in the Philadelphia Navy Yard, the center will complement our current 16,000-square-foot cGMP cell therapy manufacturing space and will be supported by fully-integrated laboratories for biological safety testing and release.
WuXi AppTec / Lion Biotechnologies Form Manufacturing Collaboration
WuXi AppTec is excited to announce a cell therapy manufacturing collaboration with Lion Biotechnologies, a clinical-stage biotechnology company focused on the development of cancer immunotherapy products. Under the new two-year agreement, WuXi AppTec will provide expanded capacities for cGMP manufacturing of Lion’s novel cancer immunotherapies based on tumor-infiltrating lymphocytes. WuXi AppTec U.S. Biologics Manufacturing and Testing will be able to provide a fully integrated service and technology platform that will be of great benefit to Lion, supporting their development efforts in this exciting field. Through the ongoing expansion of testing and manufacturing capacities at its Philadelphia facilities, WuXi AppTec continues its commitment to meeting the anticipated market needs of clinical and commercial production for cell-therapy companies around the globe. Cell-based therapies like those being developed by Lion represent vital new treatment options for cancer patients, and WuXi AppTec aims to remain at the forefront of this area by providing our partners with cutting-edge cGMP manufacturing capabilities and capacities.
Welcome Dr. Wei-Chun (Wesley) Wang to WuXi Biologics
Dr. Wei-Chun (Wesley) Wang joined us in October as Vice President of Process Development at WuXi Biologics.
Dr. Wang has more than 24 years of biopharmaceutical industry experience in the United States and was previously with Amgen, Immunex and BMS. Dr. Wang has extensive CMC leadership experience in overseeing cross-functional teams in successfully completing the CMC sections for BLA/BLAa of late phase and commercial stage mAb and Fc-fusion proteins. Dr. Wang is also a recognized expert in analytical development and product characterization of mammalian expressed glycoproteins.
U.S. Analytical Chemistry Facility in St. Paul, MN Receives ISO 17025:2005 Accreditation
WuXi AppTec’s Analytical Chemistry testing facility in St. Paul recently received ISO/IEC 17025:2005 accreditation for technical competence in the field of chemical testing. Specific services cited in the scope of accreditation are: Inductively Coupled Plasma / Mass Spectrometry (ICP/MS); Inductively Coupled Plasma / Optical Emission Spectrometry (ICP/OES); Ultra Performance Liquid Chromatography / Mass Spectrometry (UPLC/MS); Gas Chromatography / Mass Spectrometry (GC/MS); Residual Solvent Headspace Gas Chromatography / Mass Spectrometry (HSGC/MS); and Extraction.
The accreditation was received from the American Association for Laboratory Accreditation (A2LA), which conducted a review and field audit of the site.
ISO/IEC 17025 standards specifically cover the competency requirements of testing and calibration laboratories. To obtain this accreditation, the laboratory must demonstrate competence in both management and technical requirements. Management requirements cover the effective operation of a quality management system. Technical requirements relate to the competence of staff, the correctness of testing methodologies, the adequacy of equipment, and the accuracy of results. The laboratory must submit to a thorough review of its processes and procedures, including observation of actual testing being undertaken. The lab must make use of the latest scientific and technical knowledge, conduct internal audits, demonstrate continual improvement, and communicate effectively with customers. WuXi AppTec’s ISO/IEC 17025:2005 accreditation is for a renewable two-year period.
Suzhou Animal Facility Received AAALAC On-site Evaluation
In Late November, Suzhou site received two-day’s extensive on-site evaluation from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Our excellent animal management and welfare program and continuing commitment to the highest industry standard were highly commended by the Site Visitor team. This is the third time Suzhou site received such evaluation since its first accreditation in 2009.