Biopharmaceutical Contract Manufacturing

Transcription

1 S TAT E N S S E R U M I N S T I T U T Biopharmaceutical Contract Manufacturing Your Requirements Our Commitment UnderTitel SSI-Image-Brochure.indd Sec2: :31:31

2 Introduction Statens Serum Institut has been at the forefront of its field for over a century, documenting, manufacturing and procuring children s vaccine, with all the expertise and in-house facilities needed to bring your products successfully to the market. Introduction... 2 Contract work at SSI... 3 Wide-ranging capabilities Contract work scope and capabilities...6 State-of-the-art facilities...7 Contact... 8 Our motivation when handling active ingredients, formulating vaccines and conducting essential analytical work is the knowledge that our own final product will one day be given to our own children or grandchildren. At Statens Serum Institut (SSI), we know the value of caring, and our quality control and assurance systems reflect that clearly. Our processes are in compliance with cgmp and we are regularly subjected to inspections by national and international authorities as well as by our contract customers. Entrust your contract work to us, and you can relax knowing that we share your high standards. We are looking forward to working with you. We care for your products like part of the family 2 Introduction SSI-Image-Brochure.indd Sec2: :32:29

3 Contract work at SSI Statens Serum Institut was founded on September 9, 1902, just after a major outbreak of diphtheria had swept through Denmark. Its objective was to manufacture and stock sufficient diphtheria antiserum to protect the Danish population. Many of our contract agreements relate to immunology and protein chemistry, a core expertise, but also include developing non-protein hapten-based conjugate vaccines, aseptic filling of sterile protein, and non-protein solutions. Ever since, we have worked continuously on transforming our scientific achievements into practical diagnostics and biological products used to prevent and control infectious diseases and congenital disorders. Today we conduct epidemiologic surveillance in Denmark and produce and sell diagnostics as well as vaccine products and services both nationally and worldwide. As our contract partner, you will have direct access to our wide-ranging experience gained from international projects comprising manufacturing, analytical development, and research activities. This work is carried out by departments dedicated to developing and optimizing customer-defined immunochemical analyses and, if required, we also develop monoclonal and polyclonal antibodies as well as all the necessary antigen specific tests and screenings. Projects draw on our interdisciplinary expertise within protein chemistry, antigen conjugation, vaccine preparation, immunization, ELISA, assay development, cell fusion, and cell cloning. We have a full range of capabilities from API production, purification, characterization and derivatization to production of purified, characterized and quality-controlled biologicals. Quality and flexibility are our business! Contract work at SSI 3 SSI-Image-Brochure.indd Sec2: :32:47

4 R&D Development Production of API Wide-ranging capabilities Production of active ingredients (API) Production of recombinant proteins and monoclonal antibodies from pilot to full-scale production. Downstream processing for protein purification and product characterization as well as QC and release by QA/QP. Formulation Vaccine development, formulation and production are core SSI activities. For example, one of the vaccines we produce for the Danish childhood Vaccination programmed is a non-preserved pentavalent vaccine with four of the active components (diphtheria, tetanus, ap, IPV) mixed and filled in disposable ready to use syringes, with the fifth component, Hib*, in a separate vial. Other pioneering vaccine candidates are in development. Quality Assurance VACCINATION Products Incoming QC Formulation Filling Quality Control Analysis Release of Final Products Stability Studies (Final Products and API) Packaging Regulatory Final Product THERAPEUTIC Products Adjuvants are essential for a successful immune response, and at SSI we have a number of experimental adjuvant candidates, designed for inducing combined humoral and cell-mediated immune responses, available for our contract partners We can formulate products under aseptic conditions in volumes from half a liter to 200 liters, or any volumes in between. Fill and Finish For added efficiency SSI has separate filling lines for syringes and vials. And naturally, all fillings are also cgmp compliant and performed under aseptic conditions. Vials from 2 ml to 10 ml (2 4 ml is standard) and BD Hypak type syringes. Other formats are available on request. Our site is regularly inspected both by authorities and customers. A standard filling process includes: Formulation (if defined) Filling of active ingredients in vials or syringes Standard in-process controls Visual inspection Bulk packaging QP release Additional services can be agreed to suit your special requirements. * The Hib component is produced and supplied by SPMSD 4 Wide-ranging capabilities SSI-Image-Brochure.indd Sec2: :32:59

5 Quality control Quality control is cgmp compliant, and our analytical methods comply with PhEur and upon request USP. Our broad theoretical expertise is supported by valuable experience gained from transferring and validating non-standard analytical methods for contract manufacturing customers. Standard analytical methods include (but are by no means limited to): Active component analyses: Immunogenicity and toxicity in various animal species. HPLC-SEC, SDS PAGE (reduced/nonreduced), ELISA, various protein concentration methodologies, ph, appearance, extractable volume, osmolality, conductivity. Microbiological analyses: Endotoxin determinations (LAL), TOC (total organic carbon), bioburden, sterility, growth promotion/inhibition. QA and regulatory services All contract manufacturing processes and quality assurance procedures are cgmp compliant and carried out by our highly skilled specialists, who are trained and qualified to release our own and on-site contract manufactured products reliably and to meet set deadlines. Quality assurance is specified in comprehensive quality agreements to ensure that communication between SSI and contract partners is clear and concise. Physical/chemical analyses: e.g. maltose, glucose, sucrose, Polysorbate 20, Polysorbate 80, Karl Fischer titrations, opacity, aluminum. Standard fill and finish release certificates can be supplemented with more extensive documentation, on request. A summary document on processes and facilities can also be supplied as part of your contract work agreement. Wide-ranging capabilities 5 SSI-Image-Brochure.indd Sec2: :33:07

6 Contract work scope and capabilities Quality control services Preparation of active ingredients cgmp standards cgmp production of recombinant proteins PhEur/USP compliance Formulation of final bulk Stability programs for drug substances Adjuvants available and drug products Conjugation with carrier Transfer and validation of analytical methods Development of new analytical methods Fill and finish QA and regulatory services Class A/B aseptic environment for on-site contract manufacturing exclusively Batches from 50 units to commercial sizes Inspections and audits In-process controls Product release Visual control IMPD registration support Packaging BLA registration support Standard vial sizes [2 10 ml] Documents in CTD format Standard syringe sizes [1-3 ml] Other vial and syringe formats, on request 6 Contract work scope and capabilities SSI-Image-Brochure.indd Sec2: :33:24

7 State-of-the-art facilities Quality control laboratories Our laboratory facilities and equipment are state-of-the-art, and one third of the 100 staff employed in our quality control laboratories hold a PhD or a master s degree. As well as routine control of our own vaccine products, we perform in-process control, release tests and stability studies for our contract partners. Receipt control, sampling and analyses of incoming raw materials are dealt with by our Raw Materials Control Laboratory. Both drug substances and products are analyzed in three separate specialized laboratory environments, each one dedicated to particular analytical methods to ensure high-level expertise within specific areas. Microbiological controls are carried out in a laboratory exclusively for work involving microorganisms. And in addition to bio burden, sterility testing and other microbiological services, the laboratory identifies micro organisms to genus and species levels. Biological services, e.g. immunization studies, can be conducted as individual projects or as part of your contract work agreement. We offer screening for contamination with viral and other micro-organisms in biologicals, cell cultures and bulk materials using transmission electron microscopy (TEM), in relation to other Contract work or as a stand alone service. API production and Fill and Finish We have clean rooms for API production, formulation, and aseptic fill & finish and separation systems for downstream processing. The cgmp facility for API production, e.g. recombinant proteins, is validated for cgmp work. and in-process QC analyses are available for the production process. API production The API production unit carries out conjugation of haptens to carriers, e.g., tetanus toxoid, while final bulk formulation is handled in an environment dedicated to pre-filling activities i.e. concentration adjustments, mixing, sterile filtration, introduction of adjuvants etc. All activities are carried out in class A/B environments in strict compliance with cgmp. Fill and finish SSI s facility for aseptic filling of vials and syringes: This facility, which is equipped to handle both small and medium-sized productions, is also ideal for clinical trial batches. Special equipment for filling very small batches of syringes and vials from 50 to units is perfect for initial stages, e.g., toxicology studies and phase I clinical trials. State-of-the-art facilities 7 SSI-Image-Brochure.indd Sec2: :34:18

8 STATENS SERUM INSTITUT Contact Statens Serum Institut 5. Artillerivej DK-2300 Copenhagen S Tel: Fax: contractwork@ssi.dk Web: Mission Statement Statens Serum Institut prevents and controls infectious diseases, biological threats and congenital disorders. Statens Serum Institut is a public enterprise under the Danish Ministry of the Interior and Health, operating as a market-oriented production and service enterprise. Thriving base for new life science Situated at the heart of the rapidly growing Medicon Valley, the facilities and staff of Statens Serums Institute remain constantly at the cutting edge of developments in modern medicine. Statens Serum Institut aims to ensure advanced control of infectious diseases, including new infections and biological threats. The Institute also strives to be a highly regarded and recognized national and international research, production and service enterprise. SSI-Image-Brochure.indd Sec1: :30:59