000			05282nam a22003975i 4500
999			_c100912 _d100912
001			100912
003			ESmaUEC
005			20230102113017.0
006			a||||fo|||| 00| 0
007			cr nn nnnaamaa
008			180620s2018 gw | s |||| 0|eng d
020			_a9783319906034
024	7		_a10.1007/978-3-319-90603-4 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS190 _b2018 EB
245	1	0	_aChallenges in Protein Product Development _cedited by Nicholas W. Warne, Hanns-Christian Mahler.
264		1	_aCham, Switzerland _bSpringer International Publishing _c2018
300			_a1 recurso en línea (XVI, 599 páginas 130 ilustraciones,75 ilustraciones a color)
336			_aTexto _btxt _2rdacontent
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series, _x2210-7371 _v38
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_aPart 1. Formulation Development of Biologics -- Introduction into Formulation Development of Biologics -- Part 2. Challenges with Excipients -- Polysorbate Degradation and Quality -- Sucrose and Trehalose in Therapeutic Protein Formulations -- Part 3. High Concentration Proteins -- Introduction to High-Concentration Proteins -- Solubility, Opalescence & Particulate Matter -- Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations -- Practical Considerations for High Concentration Protein Formulations -- Part 4. Container-Closure Systems -- Parenteral Container Closure Systems -- Development of Prefilled Syringe Combination Products for Biologics -- Special Topics in Analytics of Pre-filled Syringes -- C Mini-Pumps -- Container Closure Integrity Testing of Primary Containers for Parenteral Products -- Chemical Durability of Glass - Delamination -- Part 5. Processing Considerations -- Bulk Protein Solution: Freeze Thaw Process, Storage and Shipping Considerations -- Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment -- Biotherapeutic Drug Product Manufacturing and Process Development -- Line Sterilization Considerations and VHP -- Lyophilization: Process Design, Robustness and Risk Management -- Fogging -- Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development -- Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product -- Part 6. Novel Constructs -- Introduction into Novel Constructs -- Novel Constructs - Half-Life Extensions -- Fc Fusion Proteins -- Part 7. Lifecycle Management -- Lifecycle Management of Biotherapeutic Dosage Forms -- Switching from an IV to an SC Formulation - Considerations for Formulation Development and Formulation Bridging.
520	3		_aIn this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
988			_aEBSPRINGER_2018
650		7	_2embne _9149216 _aMateria médica
700	1		_aWarne, Nicholas W. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aMahler, Hanns-Christian. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt _0http://id.loc.gov/authorities/names/n2010183185
710	2		_aSpringerLink (Online service) _0http://id.loc.gov/authorities/names/no2005046756 _9106996
776	0	8	_iEdición impresa: _z9783319906010
776	0	8	_iEdición impresa: _z9783319906027
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-319-90603-4 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE