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CEPiA was in a festive mood!
For the 3rd year in a row, the Life Science Leader magazine has awarded CEPiA-Sanofi as a worldwide CMO Leader in the following categories :
· CAPABILITIES :
o Facility has most up-to-date manufacturing technologies
o Offers innovative solutions
o Provides regulatory support for filing
· COMPATIBILITY :
o Access to desired markets
o Financial strength/stability
o Well-regarder within the industry
· EXPERTISE :
o Ability to smoothly scale up manufacturing and transfer technology
o Offers innovative solutions
o Experience level of staff
· QUALITY :
o Strong regulatory track record
o Up-front contingency planning, risk management
o Track record for meeting quality performance metrics
· RELIABILITY :
o Flexibility to adjust schedule for special requests
o Reliable on-time delivery
o Has capacity to meet the demands
Outside of these 5 core metrics, some of CEPiA’s INDIVIDUAL ATTRIBUTES have been highlighted :
· Accessible Senior Management
· Right the first time
· Strength of science
· Cultural fit
To attribute these awards, Life Science Leader magazine has conducted an online survey to compare 80 contract manufacturers on 26 performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and were screened for decision-making influence and authority when it comes to working with contract manufacturing suppliers. Winning CMOs were determined when comparing their overall score vs. the competitive set.
These awards and recognized successes of CEPiA with our clients are the result of our teams' great work and dedication worldwide.
Quote from Jacques Tavernier:
« I am much honored that CEPiA is recognized for the third year in a row and I strongly believe this is the result of the focus of our network on delivering high Quality standards to its customers i.e. “CEPiA’s trademark”»
CEPIA-Sanofi is recognized as the worldwide leading CMO.
CEPIA-Sanofi has been awardded the CMO leadership award within the categories quality, reliability, productivity and innovation by Life Science magazine.
The CMO Leadership Awards are designed to honor top performing service organizations based on survey reponses from thousands of pharmaceuticaland biotechnology industry executives collected annually by Nice Insight.
The award reflects that executives responsible for making or influencing outsourcing decisions at pharmaceutical and biopharmaceutical companies identified the business as a leading CMO.
This year, the CMO awards were categorized by the five main categories of buyers of outsourcedservices: big pharmaceuticals, biotech, midsized/specialty pharmaceuticals, emerging,niche or strat-up, and emerging biotech.
The categories in which CEPiA-Sanofi won were defined as:
· Reliability:Business will meet all project milestones and timelines
· Innovation: Business will enhance in-house capabilities through a new idea, method, or device
· Quality:Business will treat the project as if it was their own
· Productivity: Business will deliver on agreed objectives
An Official Ceremonywas organized in NEW YORK City on March 18, 2015 with all the peers and nominated company.
During this ceremony, the 2015 Industry Choice Awards were presented. The Industry Choice Awards were determined by averaging the perceptionscores of each CMO across the buying group categories and then ranking results.
The CEPiA Team ranked highest in industry perception scores amongst all service providers in the biotech and emerging biotech and was proud to receivethe 2015 Industry Choice award.
CEPiA-Sanofi vice-president Jacques Tavernier said: "CEPiA-Sanofi is honored to receive CMO leadership award in four cetegories and by different industry sectors.It reflects our wide and complete offer named ONE-STOP-SHOP."
The team has been also very surprised and very proud to receive“THE BEST IN CLASS” award. A second recognition considered as the HIGHEST.
CEPiA – External Manufacturing Supports Access to Medicines
Transversal collaboration and teamwork were key factors of success.
Access to Medicines tasked is to improve access to healthcare for the poorest communities in developing countries. Several programs are underway on malaria, tuberculosis, neglected tropical diseases (sleeping sickness and leishmaniasis), along with lymphatic filariasis, Chagas disease, Buruli ulcer, mental health and epilepsy.
Access to healthcare is dependent on Access to Medicines, as well as on research, on information, education, & communication (IEC) and on partnerships. Sanofi’s Department of Industrial Affairs is a key partner in producing and developing new formulations of existing drugs, such as pediatric formulations for tuberculosis.
The Notezine Project (DCI: Diethylcarbamazine citrate or DEC)
Sanofi was contacted by the WHO (World Health Organization) in 2011, when the Egyptian generics manufacturer announced in December that it would stop manufacturing this product for the WHO, and Eisai was unable to provide any before 2014. This meant that Sanofi was the only supplier already registered in Europe, USA, Japan, Canada and Australia.
There was a need for 60 million tablets in 2012 and again in 2013, principally for Myanmar and Madagascar.
As the manufacture of this medicinal product is subcontracted by Sanofi to the FAMAR (the St Genis Laval site), CEPiA teams immediately began working with Purchasing to make a “no profit, no loss" proposal to meet this request. Negotiations were conducted with the active ingredient supplier and with the subcontractor. It was also decided to restore the packaging from the Haupt Livron site to the FAMAR site to streamline the logistics process and boost productivity.
Production plans were immediately shared with the WHO logistics department so that by July 2012, more than three million tablets were shipped to the WHO. A new process, both for the supply chain, and for controlling and accounting, was set up to meet these special circumstances ( direct supply from plant to shipper, funding via donations )
This project, funded equally by Sanofi, the Bill & Melinda Gates Foundation and the Eisai laboratory, was announced in London on January 30, 2012, during the so-called “London Declaration” meeting, which brought together all players in the neglected tropical diseases constituency:
60 million tablets have been delivered each year in line with the calendar. Transversal collaboration and teamwork were the watchwords of this operation.
The CEPiA teams also handled other supply projects for the WHO, including the malaria drug ASAQ (artesunate (AS) + amodiaquine (AQ)), Paluther (Artemeter) and Arsumax (Artesunate).
“We would like to thank CEPiA teams for their outstanding work on this donation project for the WHO,” said Robert Sebbag on behalf of Access to Medicines.
Sanofi and Transgene Launch Construction Phase of New State-of-the-art Bioproduction Platform
Sanofi and Transgene SA announced today that they have launched the construction phase of the manufacturing platform dedicated to the production of viral vectors.
Sanofi, through its Genzyme Polyclonals site for the manufacturing and the CEPiA organization(Commercial & External Partnership Industrial Affairs) for all commercial aspects, will act as Transgene’s Contract Manufacturing Organization (CMO) and Transgene will be considered a preferred customer of the platform through 2028.
Customs Synthesis team has finalized on January 9th, an agreement with Isarna Therapeutics GmbH
Isarna and CEPiA Sanofi have announced a manufacturing collaboration agreement to produce clinical & commercial grade antisense Oligonucleotide (ASO).
CEPiA Sanofi will act as Isarna’s Contract Manufacturing Organization (CMO). Isarna will benefit from Sanofi’s Frankfurt site a strong expertise in this field as part of the global Oligonucleotide network.
Life Science Magazine rewards CEPiA
Every year, Life science magazine recognized, per categories, the best classified pharmaceuticals companies for theirs skills.
This year, CEPiA-US received The CMO Leadership Awards 2013, a Regulatory Award.
This success highlights the strong commitment of our CEPiA-US team.
Sanofi, the Leading Fine Chemicals Player in France – Interview with Jacques Tavernier (CEPiA)
CEPiA teams and our activities highlighted in the first publication of an interview in the magazine PharmTech Japan.
Transgene and CEPiA Sanofi have announced a collaboration agreement for the creation of a new state-of-the-art industrial platform dedicated to the production of immunotherapy products including Transgene’s therapeutic products. The platform will be realized on Genzyme Polyclonals site in Lyon - Gerland area.
CEPiA Sanofi and Genzyme will act as Transgene’s Contract Manufacturing Organization (CMO) to manufacture clinical and commercial batches of drug substance of Transgene’s immunotherapy products, including its MVA1 therapeutic vaccines. Transgene will be a preferred customer of the commercial manufacturing platform for 15 years.
Genzyme Polyclonals site in Lyon – Gerland area – is already manufacturing polyclonal antibodies for the worldwide markets. It has all the necessary capabilities to support the registration of immunotherapy products for the EU and US markets.
Construction, qualification and validation of the manufacturing suite will start in Q3 2013 and should be completed in Q1 2015. First batches of commercial grade products from the suite are expected in 2015. Transgene expects to file its first BLA2 in 2016.
DBV Technologies, creator of Viaskin®, a new standard in the treatment of allergies, has announced that it entered into a strategic manufacturing agreement with Sanofi to produce Viaskin®’s Active Pharmaceutical Ingredients (API), such as the peanut protein extract.
CEPiA Sanofi will act as DBV’s Contract Manufacturing Organization (CMO). In this context, Sanofi will scale-up and validate the production process of Viaskin®’s APIs and full supply at commercial scale. DBV will benefit from Sanofi’s strong expertise in biologics development and manufacturing in the field of plant extraction and purification of therapeutic proteins.
DBV’s APIs will be extracted and purified at the Aramon site (France). This industrial site has a long tradition as custom manufacturer, with partners from start-up company to pharmaceutical group. Aramon site has a strong expertise in the field of extraction and purification of therapeutic proteins. The production of human growth hormones by recombinant technologies started in 1984.
An investment of several million euros was made in 2010 to create a State-of-the-art biotechnology workshop through an approach combining fixed and disposable equipment.
Aramon and CEPiA combine their expertise to satisfy their multiple clients, from process development to production with quality control and regulatory support.
On January 28, 2013 Sanofi launched Auvi-Q™ in the US and Allerject in Canada for the emergency treatment of life-threatening allergic reactions in people who are at risk for anaphylaxis.
Sanofi US has licensed the rights to Auvi-Q™ in North America from Intelliject who had developed this drug/device combination. Under this license agreement Sanofi was responsible to develop and manage the industrialization of the Auvi-Q™ product for commercial use. This involved oversight and management by Sanofi’s Commercial & External Partnership Industrial Affairs (CEPiA) organization, External Manufacturing (EM) North America. EM North America was assisted in this highly complex process through consultation and support from Frankfurt Devices, SME consultants, Industrial Development & Innovation (ID&I) and the main Contract Manufacturing Organization (CMO) for assembly, Medivative.
Challenges for this project included working through 20+ individual device design changes, creating a robust trainer device, fine-tuning the supply chain process with 19 suppliers in 6 countries and 3 conti-nents, developing unique packaging for 5 SKUs for the US, 6 SKUs in Canada and creating a specialized state-of-the art final assembly line and auxiliary equipment at a cost of USD17 million.
This flexible manufacturing line takes 17 assembled parts and performs the final assembly and is built concurrently with final product design which includes 17 in-process cameras checking each step of assembly and the use of 20 robots with overall capability of assembling 6 million active devices per year. Sophisticated in-line systems check for correct audio script, LED indicators, amount of drug dispen-sed, needle length at time of dispense, dispense time, and needle retraction time.
“This project was highly successful and delivered the Auvi-Q™ product on-time with all the proper product attributes including quality, price and quantity needed for the 2 launches and shows the results of much collaboration between many teams both inside and outside Sanofi” said Ken Sylvester, Head EM North America – CEPiA.
Auvi-Q™ is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process. Auvi-Q™ is the size and shape of a credit card, the thickness of a cell phone. In addition to being an auto-injector, Auvi-Q™ features an automatic retractable needle mechanism to help prevent accidental needle sticks.
Available in two different dosages, Auvi-Q™ 0.3mg for adults and Auvi-Q™ 0.15mg for children. In Canada, Allerject is available in French language as well as English which adds some additional complexity.
Within the framework of the general policy of safety of the supply chain, Sanofi obtained in 2012 the certification AOE (Authorized Economic Operator).
To thank the teams for their contribution, the delivery of certifications to companies in the Industrial Affairs Department was held Friday, January 11th 2013 at the site of Croix de Berny in the presence of senior representatives of French customs and hosted by Philippe Luscan.
During this event, companies Francopia, Sanofi Winthrop Industry and Sanofi Chemistry have been awarded the AEO certification for their activities.
For our customers, the main benefits to retain quality certification for this are:
- Simplified customs procedures contributing to the reduction of the time of delivery of products to our manufacturing sites, distribution or export, to our customers.
- Priorities for companies in the OEA controls to accelerate the release of the goods and the choice of the place of control in line with our quality process.
- Recognition of AEO companies as partners in international security through mutual recognition between states that have made this standard.
- With this certification, Sanofi is recognized by the French customs and by European community stakeholders as reliable, capable and eligible for facilitation of procedures leading to strengthening the competitiveness of our industrial sites in France.
Issues related to this certification are important when we know that the growth of trade has risen sharply in recent years.
This status will quickly recognize the security of our international trade and help to deliver patients faster.
Congratulations to CEPiA and Industrial sites for their commitment to this certification.
* Customs compliance includes compliance of our databases, accounting procedures and practices, and regulatory information.
The new CEPiA Sales brochure, relating to the supply of Chemical & biotech APIs, has been updated.
CEPiA opened new offices with a dedicated team within the Sanofi Chinese headquarters, in Shanghai.