Baxter pharmaceutical solutions

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Contract Service Directory. Learn the options available for prefilled syringes and some considerations for developing and manufacturing the product. There are three areas to evaluate when selecting an outsourcing partner for seasonal vaccine manufacturing. Assurance of the vacuum integrity of freezedryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations.

Posters Released on Download the Enhanced Delivery Options Poster. This whitepaper discusses considerations for development of a lyophilized biosimilar, as well as a biosimilar case study. Videos Released on News Releases Released on When different drug products are produced in shared facilities, the potential for cross contamination is always a concern. Sensorion and Novasep Sign Agreement. Now has full ownership of 2X, which is being developed as an anti-cancer therapeutic, as well as being tested as an anti-viral agent against COVID To discover and develop novel oncology therapeutics against transcription factor target.

Smerud will advance development of LiPlaCis in late stage metastatic breast cancer and 2X in glioblastoma multiforme. The rise of new tools and approaches, an increase in regulatory responsibility, and the need for speed.

Bristol Myers Squibb assumes responsibility for vector manufacturing in ex-U. Aims to discover and develop novel small molecules that modulate RNA splicing for autoimmune and metabolic diseases. To develop new therapies for a range of diseases, including areas of oncology, immunology, neurology and fibrosis. Harpoon, Abbvie Expand Immunotherapy Alliance. To combine Vineti's ordering and traceability platform with WuXi's manufacturing facilities to provide end-to-end solution.

Continued and Consistent Investment in Manufacturing Facilities. As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge. Gene Therapy Trials. Ryan Carpentier of Cryoport discusses the successes and the challenges these exciting new therapies present.

Thermo retains rights to commercialize the test in all markets and will submit a supplemental premarket approval to FDA. Pricing Headwinds. With a successful combination of strong collaborations and more than 85 years of injectable drug experience, the company provides manufacturing services for a wide range of pharmaceutical drugs, including for the areas of oncology, biologics, antibody-drug conjugates ADC , small molecules and vaccines.

Baxter BioPharma Solutions helps clients with challenges in clinical supply, formulation, risk mitigation, patent expiry, scale-up of production, and addresses rises and falls in market demand. Each solution is tailored specifically for each individual case, meeting clinical, commercial, traditional, and complex issues in sterile manufacturing.

A world-class manufacturer of oncology products with more than 60 years of experience, BioPharma Solutions' facility in Halle, Westfalen, Germany is certified by Safebridge and offers dedicated clinical through commercial production. Baxter offers contract manufacturing services for a variety of sterile dosage forms, such as prefilled syringes, liquid and lyophilized vials, cartridges, and cost-saving diluents for reconstitution.

A leader in prefilled syringe fill-finish, BioPharma Solutions offers clinical through commercial sterile manufacturing. Redundant like-in-kind filling lines can help increase production potential, mitigate supply risk, and ensure on-time delivery. This facility helps clients develop and manufacture quality products and packaging, with particular expertise in regulation and lyophilisation. With more than 60 years of experience, the facility is certified by Safebridge and provides clinical and commercial production, with integrated technologies and services.

The recently expanded facility is dedicated to contract manufacturing of oncology products, such as cytotoxic, highly potent compounds, and ADCs. Capabilities include liquid and dry powder filling, sterile crystallisation, disperse systems, clinical and commercial-scale lyophilisers, and flexible compounding areas. The company provides expertise in optimisation and development in lyophilisation, converting drugs from a lyophilised to a liquid state through reformulation, converting drugs from vial to prefilled syringe form, analysing extractables and leachables, and selecting components, including flexible containers, syringes, vials, and stoppers.

Lyophilization Center of Excellence Increasing stability for injectables and improving lyophilisation cycle times are vital parts of parenteral product development. With this optimisation, Baxter BioPharma Solutions formed the Lyophilization Center of Excellence to act as a resource centre for the production of high-quality freeze-drying. The company offers: Cost-effective and targeted lab-to-product correlation for optimum product manufacturing State-of-the-art equipment for the detection of aggregation and other stability problems Automatic loading and unloading of lyophilisers to minimise microbial exposure and handling Top analytical methods for protein biophysical characterisation and measurement of aggregates Capillary electrophoresis expertise, including capillary isoelectric focusing cIEF and capillary gel electrophoresis cGE Four research freeze-dryers for development of cycles for future clinical manufacture Proven scientific approach to cycle development, verses traditional methods of trial-and-error Seasonal Vaccine Manufacturing The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection.

Manufacturing in multi-product facilities affords numerous advantages but also presents significant challenges. A prefilled syringe is a convenient primary packaging option for delivery of parenteral medication.

An industry leader with a global presence, Biopharma Solutions is a contract manufacturing organisation CMO with a focus on injectable pharmaceuticals.

Cancer incidence is on the rise and cytotoxic therapies continue to be at the centre of oncology treatment programs. Through this latest expansion in Halle, Germany, Baxter BioPharma Solutions will continue to support pharmaceutical companies' effort. Investment will add a syringe filling line, additional liquid and lyophilized freeze dried vial capacity and expand manufacturing footprint.

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