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Drug Master File Document Production Services In Germany
14 services found
by:Alfred E. Tiefenbacher (GmbH & Co. KG) based inHamburg, GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via product development and registration through to production, timely ...
by:Nanolytics GmbH based inPotsdam, GERMANY
In addition to self-association behavior (e.g. desired oligomerization), the conformational status of proteins and other biomolecules (e.g. denaturation, misfolded conformers) is crucial for understanding molecular functions and evaluate stability/safety/efficacy issues of drug products. Therefore, discriminating between size and conformation variants is an ubiquitous task in characterizing the ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. ...
by:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling batches, our scientists are highly experienced in keeping ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
ProJect Pharmaceutics* builds quality into formulation and processes and applies high-throughput predictive stability technologies (Predictive Formulation Analytics, PFA) to ensure manufacturing consistency. Using such a regulatory-compliant Quality by Design (QbD) step at an early stage will result in an accelerated and risk-mediated downstream process (DSP) development. It will also generate a ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Biological drugs are pharmaceutical drug product manufactured in, extracted from or semi synthesized from a living organism or from biological sources. Our professional scientists have rich experience in biological and pharmacological research of multiple biological drugs including peptide drugs, protein drugs, antibody drugs, antimicrobial drugs, vaccines as well as drugs involved in different ...
by:Revvity Gene Delivery (formerly SIRION Biotech) based inHamburg, GERMANY
At Revvity, we work with you to expedite the development of gene therapy vectors. ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Protein drugs are protein products with certain biological activities for the prevention and diagnosis of diseases. They can be derived from plants and animals, or developed through biotechnology research. Protein drugs in a broad sense include all products whose chemical nature is protein or polypeptide, such as hormones, growth factors/cytokines, plasma proteins, enzymes, coagulation factors, ...
Manufactured by:Heppe Medical Chitosan GmbH based inHalle (Saale), GERMANY
You need a chitosan or chitosan derivative for your medicinal product or drug or You are doing industrial research and development? Our products are particularly suitable for your ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Our drug substance manufacturing in state-of-the-art cGMP facilities meets the highest standards of the biopharmaceutical industry. To guarantee this, we follow high-quality standards within our internal processes and our team. Comprehensive quality management and precise, as well as reliable quality control, ensure excellent performance and results. We pay attention to the continuous monitoring ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Acute Radiation Syndrome (ARS) involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow makes victims vulnerable to life-threatening hemorrhage, infection and anemia. ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Bone marrow deficiency refers to a condition in which the hematopoietic stem cells in the bone marrow fail to produce enough, or produce abnormal, red blood cells, white blood cells and platelets. Hematopoietic cell transplantation (HCT), the transplantation of multipotent hematopoietic cells, is a standard treatment in various malignant and non-malignant conditions. Transplant patients are ...