Immunology and Biotherapies
13.3K views | +6 today
Follow
Immunology and Biotherapies
Page Ressources et Actualités du DIU immunologie et biothérapies
Your new post is loading...
Your new post is loading...
Scooped by Gilbert C FAURE
Scoop.it!

TNF-α inhibitor biosimilars as effective as branded counterparts, review finds

TNF-α inhibitor biosimilars as effective as branded counterparts, review finds | Immunology and Biotherapies | Scoop.it
Biosimilar tumour necrosis factor (TNF)-α inhibitors have similar efficacy and safety profiles to their branded equivalents, the authors of a systematic review conclude. 
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

A new drug that could save the US billions just got one step closer to an approval

A new drug that could save the US billions just got one step closer to an approval | Immunology and Biotherapies | Scoop.it
An approved biosimilar of the blockbuster drug Humira could change the way biosimilars are used.
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

EMA Accepts Submission for Rituximab Biosimilar

EMA Accepts Submission for Rituximab Biosimilar | Immunology and Biotherapies | Scoop.it
​Sandoz, a Novartis division and the global leader in biosimilars, announced today that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche's EU-licensed MabThera (rituximab).
more...
No comment yet.
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Biosimilars Segment—A Fast-Moving Blur

Biosimilars Segment—A Fast-Moving Blur | Immunology and Biotherapies | Scoop.it
Biosimilars (and related biobetters) represent a new biopharmaceutical product category as well as a new industry segment. So far, over 20 biosimilars have been approved in major markets, primarily the European Union. Only two biosimilars have been approved in the United States.
Most agree that the biosimilars segment will grow quickly and generate many biopharmaceutical products, innovations, and manufacturing facilities. But there is little consensus with regard to basic industry metrics. For example, sales forecasts for the next five years commonly vary by an order of magnitude, from $2 billion to $20+ billion/year. There is not even agreement yet on what names should be used for existing biosimilars.
For the most part, information resources about and supporting biosimilar development have yet to be developed. This is particularly true for data related to bioprocessing and other more technical aspects.
The poor state of biosimilars-related information resources is due to a l
Via Krishan Maggon
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Remicade monitoring test validated for use in IBD patients treated with Inflectra

Remicade monitoring test validated for use in IBD patients treated with Inflectra | Immunology and Biotherapies | Scoop.it
The Prometheus Anser IFX test has been validated for use in patients with inflammatory bowel disease treated with Inflectra, the manufacturer announced.Inflectra (Celltrion) is the recently FDA-approved biosimilar of Remicade (infliximab, Janssen),...
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Top five articles on biosimilars include nods to FDA approval

Top five articles on biosimilars include nods to FDA approval | Immunology and Biotherapies | Scoop.it
The most highly accessed articles about biosimilars on Healio.com/Rheumatology have largely focused on the reaction to the FDA approval of the first biosimilar to infliximab in the United States.
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Biosimilar drugs could save up to €98bn by 2020, says IMS

Biosimilar drugs could save up to €98bn by 2020, says IMS | Immunology and Biotherapies | Scoop.it
But savings from lower-cost copies depend on doctor education, healthcare provider strategies
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

The Emerging Biosimilar Therapeutic Landscape: Scientific Foundations and Clinical Implications - CME/CNE/CPE Information | Endocrinology | Education Lab | CME

The Emerging Biosimilar Therapeutic Landscape: Scientific Foundations and Clinical Implications - CME/CNE/CPE Information | Endocrinology | Education Lab | CME | Immunology and Biotherapies | Scoop.it

Education Lab | CME | Recent processes have been established to facilitate the production, validation, and utilization of biosimilars.

Gilbert C FAURE's insight:

Recent processes have been established to facilitate the production, validation, and utilization of biosimilars. Biosimilars are therapeutic products similar in quality, safety, and efficacy to already-licensed reference biotherapeutic products. Used widely in Europe since 2006, the first biosimilar agent for use in the United States was approved in March 2015. In May of 2015, a Biosimilars Forum was launched in the United States to advance nationwide awareness and use of biosimilars. This monograph will discuss the emerging biosimilar landscape and its clinical implications.

more...
No comment yet.
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13

The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13 | Immunology and Biotherapies | Scoop.it
(2015). The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13. Expert Review of Gastroenterology & Hepatology: Vol. 9, Biosimilars for anti-TNF therapy: a case study of the first infliximab biosimilar, CT-P13, pp. 17-26. doi: 10.1586/17474124.2015.1091306

 

Abstract
Extrapolation of clinical data from other indications is an important concept in the development of biosimilars. This process depends on strict comparability exercises to establish similarity to the reference medicinal product. However, the extrapolation paradigm has prompted a fierce scientific debate. CT-P13 (Remsima®, Inflectra®), an infliximab biosimilar, is a TNF antagonist used to treat immune-mediated inflammatory diseases. On the basis of totality of similarity data, the EMA approved CT-P13 for all indications held by its reference medicinal product (Remicade®) including inflammatory bowel disease. This article reviews the mechanisms of action of TNF antagonists in immune-mediated inflammatory diseases and illustrates the comparable profiles of CT-P13 and reference medicinal product on which the extrapolation of indications including inflammatory bowel disease is based.

Via Krishan Maggon
more...
Krishan Maggon 's curator insight, December 20, 2015 2:43 AM
Expert Review of Gastroenterology & HepatologyVolume 9, Supplement 1, 2015Special Issue:   Biosimilars for anti-TNF therapy: a case study of the first infliximab biosimilar, CT-P13

 

DOI:10.1586/17474124.2015.1091306

Walter Reinisch*a, Edouard Louisb & Silvio Danesec

pages 17-26

Publishing models and article dates explained
Published online: 22 Sep 2015
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Biosimilar monoclonal antibodies: the scientific basis for extrapolation

Biosimilar monoclonal antibodies: the scientific basis for extrapolation | Immunology and Biotherapies | Scoop.it
(2015). Biosimilar monoclonal antibodies: the scientific basis for extrapolation. Expert Opinion on Biological Therapy: Vol. 15, No. 11, pp. 1633-1646. doi: 10.1517/14712598.2015.1083552

 

Abstract

Introduction: Biosimilars are biologic products that receive authorization based on an abbreviated regulatory application containing comparative quality and nonclinical and clinical data that demonstrate similarity to a licensed biologic product. Extrapolation of safety and efficacy has emerged as an important way to simplify biosimilar development. Regulatory authorities have generally reached the consensus that extrapolation of similarity from one indication to other approved indications of the reference product can be permitted if it is scientifically justified.

Areas covered: Recently, the first biosimilar, biosimilar infliximab (Remsima/Inflectra) to the innovator monoclonal antibody infliximab (Remicade), was approved in the European Union, Canada and South Korea; the USA subsequently approved its first biosimilar, a less complex molecule (filgrastim-sndz). Based on two clinical trials of biosimilar infliximab in patients with rheumatoid arthritis and ankylosing spondylitis, the European Medicines Agency allowed extrapolation to all eight approved indications for innovator infliximab, whereas Health Canada did not permit extrapolation to the indications for ulcerative colitis and Crohn’s disease. These differing decisions on extrapolation of indications for biosimilar infliximab highlight important unanswered regulatory and scientific questions. Here, we propose substantive scientific considerations for indication extrapolation.

Expert opinion: The preclinical and clinical criteria that are currently required to merit indication extrapolation have not been rigorously evaluated.


Via Krishan Maggon
Gilbert C FAURE's insight:

major concerns

more...
Krishan Maggon 's curator insight, November 20, 2015 3:49 AM
Expert Opinion on Biological TherapyVolume 15, Issue 11, 2015
Select Language▼
Translator disclaimer
ReviewsBiosimilar monoclonal antibodies: the scientific basis for extrapolation
 
 
DOI:10.1517/14712598.2015.1083552Huub Schellekens MD PhD Professora, Erika Lietzan MA JDAssociate Professorb, Freddy Faccin MD*c & Jaap Venema PhDd

pages 1633-1646

Publishing models and article dates explained
Published online: 12 Sep 2015
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Virtual Special Issue from mAbs... | Explore Taylor & Francis Online

Virtual Special Issue from mAbs... | Explore Taylor & Francis Online | Immunology and Biotherapies | Scoop.it

Analytical and Structural Characterization of Antibodies and Related Products

Monoclonal antibodies (mAbs) are highly complex tetrameric glycoproteins that must be extensively analytically and structurally characterized to become drug candidates. This is also true for biosimilar and biobetter antibodies, glyco-engineered antibodies and IgG-based molecules such as Fc-fusion proteins and peptides, as well as for antibody-drug conjugates, bi- and multi-specific antibodies and antibody mixtures. Since the first issue in 2009, mAbs has become well-known and valued by authors and readers for its publication of high-quality research papers and reviews on antibody and related product analytical and structural characterization. In this virtual issue on antibody characterization, we highlight 20 recently published articles that will be useful for numerous scientists involved in therapeutic antibody research and development.

Antibody Structural Assessment and Extensive Glyco-Profiling

A correct primary structure assessment and extensive glyco-profiling is the cornerstone of antibody characterization. As reported by Ayoub et al., a combination of intact, middle-down, middle-up and bottom-up mass spectrometry (MS) techniques is the workflow of choice to characterize the amino acid sequence and the major post-translational modifications of antibodies such as cetuximab. Interestingly, an unexpected sequence error near the light chain C-terminus present in public databases was identified, and full Fd and Fc glycoprofiling was provided. Another in-depth qualitative and quantitative analysis on intact mAbs by high-resolution native MS was reported by Rosati et al.Alternatively, Gahoual et al. demonstrated for the first time that capillary electrophoresis tandem MS (CESI-MS/MS) may be a valuable option for 100% sequence coverage for both heavy and light chain of representative therapeutic antibodies such as trastuzumab (3). IgG glycans represent an average of only 2−3% of the total antibody mass, but they are one of the critical quality attributes for therapeutic candidates. Extensive comparisons of both separation- and MS-based methods for analysis of Fc-glycosylation profiles were recently reported by Reusch et al.

Critical Quality Attributes: Charge Variants

As reviewed by Du et al., numerous micro-variants are commonly observed when mAbs are analyzed by charged-based separation techniques such as isoelectric focusing gel electrophoresis (IEF), capillary IEF (cIEF), imaged capillary IEF (icIEF), and cation and anion exchange chromatography. Many of the modifications leading to the formation of acidic and basic species have been identified by analyzing fractions collected from chromatography-based methods, with the aim of further analyzing their impact on safety, pharmacokinetics and pharmacodynamics. Those located in antibody complementarity-determining regions are often considered to be the most critical because they are surface exposed and often involved in the antigen binding. Importantly, Haberger et al. investigated specific stress conditions such as elevated temperatures, pH, oxidizing agents, and forced glycation to rank the functional criticality. Interestingly, Tang et al. reported the successful use of hydrogen/deuterium exchange MS (HDX-MS) for the conformational characterization of the charge variants of IgGs. Finally, to help researchers in the identification and mitigation of non-human modifications of antibody therapeutics, Liu et al. recently reviewed the most frequently observed modifications of recombinant monoclonal and endogenous IgG molecules.

Antibody Developability

Understanding of structure-function relationships may help to mitigate the development risk of new drug candidates. Such developability studies are an important link between drug discovery and process development activities. After expression of a proposed therapeutic biologic in the selected host organism, assessment of the molecule’s stability, resistance to degradation and solubility is needed to determine critical quality attributes, as is encouraged by the Quality by Design paradigm.Yang et al. devised a set of experiments to assess developability, and reported three cases studies reflecting typical outcomes for mAbs. Another rapid and informative methodology based on the heavy chain-degrading enzyme of Streptococcus pyogenes (IdeS) and reduction was reported by An et al.Their method enables domain-specific profiling of oxidation, charge heterogeneity, and glycoform distribution of different therapeutic antibody subclasses (IgG1, IgG2, IgG4).

Host Cell Proteins

Quantification of host-cell proteins (HCPs) in biotherapeutic proteins such as mAbs are most frequently performed by process-specific enzyme-linked immunosorbent assays (ELISAs). Alternatively, Doneanu et al. reported the use of HCP identification using comprehensive online two-dimensional liquid chromatography (LC) coupled with high-resolution MS (2D-LC/MS), followed by high-throughput HCP quantification by LC-multiple reaction monitoring (LC-MRM) over 5 orders of magnitude. A similar strategy was also reported by Zhang et al. during the purification process of therapeutic mAbs.

Biosimilars and Biobetters

In 2013, the European Medicines Agency granted the first marketing authorization for a biosimilar mAb (infliximab, Remsima®). In Europe and in the US, biosimilars are versions of an already authorized biological medicinal product with identical sequence and demonstrated similarity in physicochemical characteristics, efficacy and safety, based on a comprehensive comparability exercise. As reported byXie et al., rapid comparison of the trastuzumab originator mAb and a biosimilar candidate can be performed by LC coupled to MS-based methods (LC-MS and LC-MS/MS). Importantly, Jung et al.reported the full set of physicochemical characterizations that resulted in the approval of Remsima®. Last but not least, Gahoual et al. reported the successful use of capillary electrophoresis coupled to MS for the evaluation of both biosimilar and biobetter candidates.

Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) are a potent subclass of antibodies actively investigated in numerous cancers. Compared to naked mAbs, ADCs have an increased level of complexity because the heterogeneity of conjugation results in the inherent microvariability of the IgGs. The first extensive review on analytical methods for physicochemical characterization of ADCs was published byWakankar et al. in 2011. More recently, Wagner-Rousset et al. reported for the first time the successful use of IdeS for the fast characterization of ADCs. The workflow allowed the determination of drug loading and distribution on both light chain and Fd fragments, as well as full glyco-profiling and demonstration of the absence of additional conjugation in the Fc fragment.

Bispecific Antibodies

Bispecific, asymmetric antibodies present unique challenges for drug development due to their heterodimeric structures. Woods et al. reported LC-MS methods developed for rapid and accurate detection and quantification of heterodimeric antibodies and relative quantification of low abundance homodimeric and half-antibody impurities.

Antibody Mixtures

Antibody mixtures present another rapidly emerging modality in the field of biopharmaceuticals. Again, improved mass resolving power allows highly complex mixtures to be accurately characterized both in terms of their individual components and the relative amounts of each antibody in the sample, as reported by Thompson et al. The applications of native MS with high-resolution mass analysis are a complementary tool in product characterization and screening of antibody mixtures.

Fc-fusion Proteins

Fc-fusion technologies, in which the Ig Fc is fused genetically to a protein or peptide of interest, have emerged to confer antibody-like properties on proteins and peptides of therapeutic interest with a high approval success rate. This subclass of IgGs represents analytical challenges that can be successfully addressed by MS based method following IdeS digestion, as reported by Lynaugh et al.


Via Krishan Maggon
more...
Krishan Maggon 's curator insight, September 17, 2015 8:01 PM

Special virtual issue of mAbs

Scooped by Gilbert C FAURE
Scoop.it!

Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases, Immunotherapy, Future Medicine

Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases, Immunotherapy, Future Medicine | Immunology and Biotherapies | Scoop.it
Progress #biosimilar monoclonal antibody development: infliximab biosimilar CT-P13 in treatment of rheumatic diseases
http://t.co/yk4gWET4JC
more...
No comment yet.
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Progress and Hurdles for Follow-on Biologics — NEJM

Progress and Hurdles for Follow-on Biologics — NEJM | Immunology and Biotherapies | Scoop.it
Perspective from The New England Journal of Medicine — Progress and Hurdles for Follow-on Biologics

 

The challenges to achieving savings from follow-on biologics are large but not insurmountable. First, market-entry hurdles should be low enough to ensure that enough companies compete to affect prices. Public investment in technological advances that can support biosimilar development, such as advancing knowledge about glycosylating human proteins in yeast, can aid all manufacturers. The FDA can help by promulgating product-specific guidance on how companies can demonstrate biosimilarity or interchangeability, to reduce the disadvantages for the first companies to try. Legislators may also need to reexamine the process for exchanging information about potentially infringing patents, to ensure that innovator manufacturers cannot unreasonably delay the process in order to extend their market exclusivity, and to prevent biosimilar manufacturers from entering into anticompetitive settlements. Such settlements have bedeviled the generic small-molecule drug industry but, since 2003, have had to be reported to the Federal Trade Commission for evaluation of their anticompetitive effects. This requirement may have to be extended to biologic drugs.

Innovative approaches will be required to ensure mandatory, rigorous postapproval research on the safety and effectiveness of biosimilars compared with their innovator predecessors in order to promote confidence in these new products. Over the long term, attention to both these areas will help ensure that U.S. patients benefit from appropriate price reductions for older biologic drugs that are essential for their clinical care. At the same time, fair but appropriately limited periods of exclusivity will reward the innovators of the original products while also spurring them to create new products rather than prolong exclusivity rights over older ones long after such monopolies should have come to a natural end.


Via Krishan Maggon
more...
Krishan Maggon 's curator insight, May 7, 2015 2:11 AM

Perspective

Progress and Hurdles for Follow-on Biologics

Ameet Sarpatwari, J.D., Ph.D., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

May 6, 2015DOI: 10.1056/NEJMp1504672

Share:      
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Biosimilars: A Review and Requirements for Pharmacists

Biosimilars: A Review and Requirements for Pharmacists | Immunology and Biotherapies | Scoop.it
In March 2015, the FDA approved the first biosimilar.
Via Krishan Maggon
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Biosimilar Era Gets Rolling in Oncology

Biosimilar Era Gets Rolling in Oncology | Immunology and Biotherapies | Scoop.it
After years of anticipation, biosimilar versions of the most widely administered monoclonal antibodies in oncology care are moving closer to fruition for the US market, starting with a new form of trastuzumab (Herceptin).
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

JHL Biotech opens new biosimilar manufacturing facility in China

JHL Biotech opens new biosimilar manufacturing facility in China | Immunology and Biotherapies | Scoop.it
JHL Biotech (JHL) opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China.
more...
No comment yet.
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Pharmacology and metabolism of infliximab biosimilars - A new treatment option in inflammatory bowel diseases. - PubMed - NCBI

Pharmacology and metabolism of infliximab biosimilars - A new treatment option in inflammatory bowel diseases. - PubMed - NCBI | Immunology and Biotherapies | Scoop.it
Pharmacol Rep. 2016 Apr 26. pii: S1734-1140(16)30024-X. doi: 10.1016/j.pharep.2016.04.006. [Epub ahead of print] REVIEW

Abstract Biological therapy with monoclonal antibodies to tumor necrosis factor alpha (TNF-α) was shown in large clinical trials to be effective in inducing and maintaining clinical remission in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Infliximab, the first anti-TNF-α biologic drug, has significantly improved inflammatory bowel disease (IBD) treatment outcomes by preventing structural damage progression, thereby reducing complications and the need for surgery and hospitalization. The major concern associated with the use of biologics is their high cost. However, as these therapies lose patent protection, cheaper biosimilar versions of the originator products are being developed, such as the infliximab biosimilar CT-P13. Position statements from several scientific societies and some experts in their reviews have expressed concerns to the concept of extrapolation without direct IBD clinical evidence, whereas European Medicines Agency (EMA) experts have supported extrapolation. In this review, we focus on the pharmacokinetics, pharmacodynamics properties and comparative effectiveness of anti-TNF-α biosimilars, related to their use in IBD.

Via Krishan Maggon
more...
Krishan Maggon 's curator insight, May 12, 4:03 AM
Pharmacol Rep. 2016 Apr 26. pii: S1734-1140(16)30024-X. doi: 10.1016/j.pharep.2016.04.006. [Epub ahead of print] 

Pharmacology and metabolism of infliximab biosimilars - A new treatment option in inflammatory bowel diseases. 

Włodarczyk M1, Fichna J2, Sobolewska-Włodarczyk A3.
Scooped by Gilbert C FAURE
Scoop.it!

Highly read articles on psoriatic arthritis highlight news in biologics, biosimilar therapies

Highly read articles on psoriatic arthritis highlight news in biologics, biosimilar therapies | Immunology and Biotherapies | Scoop.it


Biologics, and particularly biosimilars, have been in the news about psoriatic arthritis and other rheumatic, dermatologic and gastrological diseases.
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Real-world biosimilar data driving physician acceptance, says Celltrion

Real-world biosimilar data driving physician acceptance, says Celltrion | Immunology and Biotherapies | Scoop.it
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Scrip Regulatory Affairs - WHO Draft Guidelines On Biosimilar MAbs: Extrapolation 'A Goal' Of Development Program

The World Health Organization has launched a public consultation on proposed draft guidelinessup1/sup for the evaluation of biosimilar monoclonal antibodies (MAbs) to complement its existing 2009 guidance on...
more...
No comment yet.
Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
Scoop.it!

Biosimilars: Prepare for evolving landscape, complexities

Biosimilars: Prepare for evolving landscape, complexities | Immunology and Biotherapies | Scoop.it

The new year started with one FDA-approved biosimilar drug on the market and at least five others in the pipeline.


Via Krishan Maggon
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Remicade biosimilars launched

Remicade biosimilars launched | Immunology and Biotherapies | Scoop.it
It is the first biosimilar monoclonal antibody in many European markets: Mundipharma and Hospira are launching Celltrion’s Remicade generic.
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept - MarketWatch

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept - MarketWatch | Immunology and Biotherapies | Scoop.it
FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept MarketWatch Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is...
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

Cost and Time Effective Approach to Early Stage Biosimilar Development: A Case Study of Tocilizumab

Cost and Time Effective Approach to Early Stage Biosimilar Development: A Case Study of Tocilizumab | Immunology and Biotherapies | Scoop.it
New insights into the monoclonal antibody Tocilizumab from Terry & Sartorius Stedim @ http://t.co/fnmgXNfN3H
more...
No comment yet.
Scooped by Gilbert C FAURE
Scoop.it!

USP Publishes Monoclonal Antibody Guidelines - Compliance Team Inc

USP Publishes Monoclonal Antibody Guidelines - Compliance Team Inc | Immunology and Biotherapies | Scoop.it
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expanded in healthcare, raising questions and presenting crucial issues associated with their quality and efficacy.
Gilbert C FAURE's insight:

USP standards for mAbs
Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, the United States Pharmacopeial Convention’s (USP) expert panel decided to focus its efforts in developing standards for mAbs on a class of molecules that would be more amenable to a “platform approach” both in terms of manufacturing and analytical development.

USP has been involved in developing quality standards for biologics as part of its expanding portfolio of monographs and general chapters for a long time. In 2012, USP started working on a clearly defined set of quality expectations for recombinant therapeutic mAbs, United States Pharmacopeia (USP) General Chapter <129> “Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies,” which is set to become official in USP’s compendia of standards, USP 39–National Formulary (NF) 34, on May 1, 2016.

As individual product monographs will possibly describe specific quality attributes of individual drugs, USP deemed it necessary to have a broad foundation of general standards to set minimum quality requirements for molecule classes, and that is what it hopes to achieve with the publication of the new general chapter.

General Chapter <129> provides analytical procedures for murine, chimeric, and humanized IgG isotype mAbs and subtypes (e.g., IgG1 and IgG2). Because subclasses show differences in amino acid sequence and in the number of disulfide bonds, in some cases they require subclass-specific analysis. IgG-type monoclonal antibodies have a molecular weight of approximately 150 kDa. Each molecule consists of two heavy and two light polypeptide chains that have a molecular weight of approximately 50 and 25 kDa, respectively.

more...
No comment yet.