Chapter 31. Good Manufacturing Practice for Sterile Products

The application of somatic stem cells has been shown to support the recovery of the myocardium in end-stage heart failure. A novel method for the intraoperative isolation and labeling of bone marrow-derived stem cells was established. After induction of general anesthesia, up to 400 mL of bone marrow were harvested from the posterior iliac crest and processed in the operating room under good manufacturing practice conditions by means of the automated cell-selection device Clini-MACS (Miltenyi Biotec). We subsequently injected autologous CD133<sup>+</sup> and CD34<sup>+</sup> stem cells in a predefined pattern around the laser channels in patients undergoing coronary artery bypass surgery and transmyocardial laser procedures. Intraoperative isolation and labeling is an effective cell-separation tool for the future, considering that novel cell markers can be promising new candidates for cell therapy.

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Faculty Opinions recommendation of Tips and tricks for validation of quality control analytical methods in good manufacturing practice mesenchymal stromal cell production.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.737361017.793570946 ◽

2020 ◽

Author(s):

Karen Bieback

Keyword(s):

Quality Control ◽

Analytical Methods ◽

Mesenchymal Stromal Cell ◽

Stromal Cell ◽

Good Manufacturing Practice ◽

Tips And Tricks ◽

Cell Production

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Good Manufacturing Practice Regulations for Probiotic Based Pharmaceuticals: Current Scenario and Suggestive Recommendations

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x03666160127001910 ◽

2016 ◽

Vol 03 (999) ◽

pp. 1-1

Author(s):

Malika Arora ◽

Ashish Baldi

Keyword(s):

Good Manufacturing Practice ◽

Current Scenario

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Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements

Molecules ◽

10.3390/molecules26061566 ◽

2021 ◽

Vol 26 (6) ◽

pp. 1566

Author(s):

Elena Fabris ◽

Michela Bulfoni ◽

Alessandro Nencioni ◽

Emanuele Nencioni

Keyword(s):

Dietary Supplements ◽

Good Manufacturing Practice ◽

Activity Measurement ◽

Intermediate Precision ◽

Method Performance ◽

Intestinal Gas ◽

Technical Requirements ◽

Ich Guidelines ◽

Alpha Galactosidase

Introduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digested food residuals. Therefore, α-Gal is used in dietary supplements to reduce intestinal gases and help complex food digestion. Marketed enzyme-containing dietary supplements must be produced in accordance with the Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practice (cGMPs). Aim: in this work we illustrated the process used to develop and validate a spectrophotometric enzymatic assay for α-Gal activity quantification in dietary supplements. Methods: The validation workflow included an initial statistical-phase optimization of materials, reagents, and conditions, and subsequently a comparative study with another fluorimetric assay. A final validation of method performance in terms of specificity, linearity, accuracy, intermediate-precision repeatability, and system precision was then executed. Results and conclusions: The proven method achieved good performance in the quantitative determination of α-Gal activity in commercial food supplements in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) guidelines and is suitable as a rapid in-house quality control test.

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Preclinical Development of Autologous Hematopoietic Stem Cell-Based Gene Therapy for Immune Deficiencies: A Journey from Mouse Cage to Bed Side

Pharmaceutics ◽

10.3390/pharmaceutics12060549 ◽

2020 ◽

Vol 12 (6) ◽

pp. 549

Author(s):

Laura Garcia-Perez ◽

Anita Ordas ◽

Kirsten Canté-Barrett ◽

Pauline Meij ◽

Karin Pike-Overzet ◽

...

Keyword(s):

Gene Therapy ◽

Severe Combined Immunodeficiency ◽

Good Manufacturing Practice ◽

Proof Of Concept ◽

Preclinical Development ◽

Hematopoietic Stem ◽

Immune Deficiencies ◽

Suitable Vector

Recent clinical trials using patient’s own corrected hematopoietic stem cells (HSCs), such as for primary immunodeficiencies (Adenosine deaminase (ADA) deficiency, X-linked Severe Combined Immunodeficiency (SCID), X-linked chronic granulomatous disease (CGD), Wiskott–Aldrich Syndrome (WAS)), have yielded promising results in the clinic; endorsing gene therapy to become standard therapy for a number of diseases. However, the journey to achieve such a successful therapy is not easy, and several challenges have to be overcome. In this review, we will address several different challenges in the development of gene therapy for immune deficiencies using our own experience with Recombinase-activating gene 1 (RAG1) SCID as an example. We will discuss product development (targeting of the therapeutic cells and choice of a suitable vector and delivery method), the proof-of-concept (in vitro and in vivo efficacy, toxicology, and safety), and the final release steps to the clinic (scaling up, good manufacturing practice (GMP) procedures/protocols and regulatory hurdles).

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A Good Manufacturing Practice–grade standard protocol for exclusively human mesenchymal stromal cell–derived extracellular vesicles

Cytotherapy ◽

10.1016/j.jcyt.2017.01.001 ◽

2017 ◽

Vol 19 (4) ◽

pp. 458-472 ◽

Cited By ~ 66

Author(s):

Karin Pachler ◽

Thomas Lener ◽

Doris Streif ◽

Zsuzsanna A. Dunai ◽

Alexandre Desgeorges ◽

...

Keyword(s):

Extracellular Vesicles ◽

Mesenchymal Stromal Cell ◽

Stromal Cell ◽

Good Manufacturing Practice ◽

Standard Protocol

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Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions

Cytotherapy ◽

10.1016/j.jcyt.2013.12.008 ◽

2014 ◽

Vol 16 (6) ◽

pp. 750-763 ◽

Cited By ~ 42

Author(s):

Sara Castiglia ◽

Katia Mareschi ◽

Luciana Labanca ◽

Graziella Lucania ◽

Marco Leone ◽

...

Keyword(s):

Mesenchymal Stromal Cell ◽

Stromal Cell ◽

Human Platelet ◽

Good Manufacturing Practice ◽

Platelet Lysate ◽

Cell Production ◽

Human Platelet Lysate ◽

New Perspective

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RG1-VLP and Other L2-Based, Broad-Spectrum HPV Vaccine Candidates

Journal of Clinical Medicine ◽

10.3390/jcm10051044 ◽

2021 ◽

Vol 10 (5) ◽

pp. 1044

Author(s):

Bettina Huber ◽

Joshua Weiyuan Wang ◽

Richard B. S. Roden ◽

Reinhard Kirnbauer

Keyword(s):

Small Animal ◽

Good Manufacturing Practice ◽

Special Focus ◽

T Cell Epitopes ◽

Hpv Vaccines ◽

Structural Protein ◽

Vaccine Candidates ◽

Protective Antibodies ◽

Minor Structural Protein ◽

Hpv Types

Licensed human papillomavirus (HPV) vaccines contain virus-like particles (VLPs) self-assembled from L1 major-capsid proteins that are remarkably effective prophylactic immunogens. However, the induced type-restricted immune response limits coverage to the included vaccine types, and costly multiplex formulations, restrictive storage and distribution conditions drive the need for next generation HPV vaccines. Vaccine candidates based upon the minor structural protein L2 are particularly promising because conserved N-terminal epitopes induce broadly cross-type neutralizing and protective antibodies. Several strategies to increase the immunological potency of such epitopes are being investigated, including concatemeric multimers, fusion to toll-like receptors ligands or T cell epitopes, as well as immunodominant presentation by different nanoparticle or VLP structures. Several promising L2-based vaccine candidates have reached or will soon enter first-in-man clinical studies. RG1-VLP present the HPV16L2 amino-acid 17–36 conserved neutralization epitope “RG1” repetitively and closely spaced on an immunodominant surface loop of HPV16 L1-VLP and small animal immunizations provide cross-protection against challenge with all medically-significant high-risk and several low-risk HPV types. With a successful current good manufacturing practice (cGMP) campaign and this promising breadth of activity, even encompassing cross-neutralization of several cutaneous HPV types, RG1-VLP are ready for a first-in-human clinical study. This review aims to provide a general overview of these candidates with a special focus on the RG1-VLP vaccine and its road to the clinic.

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Product quality of kaledo, a local food of Palu City Indonesia

Food Research ◽

10.26656/fr.2017.5(4).716 ◽

2021 ◽

Vol 5 (4) ◽

pp. 273-278

Author(s):

Y.I. Jayadi ◽

A. Astari ◽

R. Ekasari ◽

U. Aiman ◽

N.U. Dewi

Keyword(s):

Hazard Analysis ◽

Control Point ◽

Good Manufacturing Practice ◽

Cross Sectional Study ◽

Chemical Contamination ◽

Self Assessment ◽

Cross Sectional ◽

Critical Control Point ◽

Cooking Process ◽

Physical And Chemical

Food safety is an important issue in the incidence of foodborne diseases in society. Kaledo is one of the “must-try” traditional foods of Palu City, Indonesia. The main ingredients used for making this dish are beef and cow’s trotters, which are highly susceptible to microbiological, physical, and chemical contamination. This cross-sectional study aimed to analyze the Good Manufacturing Practice (GMP) and Hazard Analysis Critical Control Point (HACCP) in one of the culinary businesses in Palu City. The GMP assessment was carried out using the self-assessment questionnaire developed by Food Supplements Europe. The results of this study indicated that Kaledo X Food Stall still had not implemented GMP. However, HACCP analysis showed a critical control point (CCP) in the cooking process of Kaledo, i.e., at the time of boiling the meat and bones.

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