Biologics Analytical Services

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+1-609-604-8303

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bd_global@crystalpharmatech.com

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Biologics Analytical Services

What are Biologics

Biologics are highly complex molecules that are primarily derived from living species such as human, animal, and microorganisms or recombinantly produced using living cells. According to the US FDA, biologics include "a wide range of products such as vaccines, blood and blood components, allergens, somatic cells, gene therapy, tissues and recombinant therapeutic proteins." Biologics can be carbohydrates, proteins, lipids, nucleic acids or a complex mixture of these substances.

How do Biologics work and Why are they unique?

Biologics are being used as drugs to treat a variety of human and animal diseases including autoimmune diseases such as rheumatoid arthritis. In the case of autoimmune diseases, some biologics interrupt signals, and pathways in the immune system to reduce the damage inflicted by the autoimmune conditions. Biologics can be very micro-heterogenous mixtures of structural variants that are difficult to identify and characterize. Biological products are generally heat sensitive and susceptible to microbial contamination.

How are Biologics approved by FDA?

Biologics also referred to as Biopharmaceuticals, and are regulated in USA by the Center for Biologics Evaluation and Research (CBER) division of FDA. These biologics need to go through different clinical phases (I, II, and III) of drug development followed by the Biologics Licensing Application (BLA) process for approval by FDA prior to commercialization and marketing.

Categories of Biologics and their applications

Some of the general categories of biologics include:

Vaccines (used for disease prevention)
Recombinant proteins (such as insulin or erythropoietin)
Interleukins (immune molecules that can be used to treat certain infections and cancers)
Monoclonal antibodies (like those used to treat autoimmune diseases and cancer)
Bispecific antibodies (next generation strategy for antibodies-to target human diseases such as cancer immunotherapy)
Stem cell therapies (to treat human diseases such as certain cancers or genetic diseases)
Other cell therapies (like Chimeric Antigen Receptor T cells used to treat cancer)
Gene therapies (to treat disease such as those for genetic conditions), etc.

Crystal Pharmatech Inc. is a technology driven CRO and CDMO that offers solid-state services for active pharmaceutical ingredients and formulations. Biologics Analytical Services (BAS) is a division of Crystal Pharmatech, where we focus on providing analytical services to biopharmaceutical industry from discovery research, preclinical and clinical phases to commercialization.

Biologics Analytical Services has a state-of-the-art analytical laboratory and a staff with extensive experience in biologics analytical development and quality control.

We strive to provide high quality services to our customers to bring their products to market to help the patients in need of quality biopharmaceuticals to treat their diseases.

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Characterization of Biologics

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Comparability Studies

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Analytical Method Development

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Analysis, Purification and Characterization of Impurities

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Biosimilars Development

Characterization of biologics plays an important role in their development as human therapeutics. As per FDA, EU, ICH Q6B and other regulatory guidelines, development of biopharmaceutical products requires providing sufficient Chemistry, Manufacturing and Controls (CMC) information of both Drug Substance (DS) and Drug Product (DP). Following are the hightlights of our services on characterization of biologics:

Analysis of Proteins
Structural Analysis Including Higher Order Structure Analysis
Analysis and Characterization of Post-Translational Modifications
Impurities Analysis
Degradation Studies
Biological Characterization

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Comparability studies are important to ensure that a process change made during the process development and/or manufacturing will not have an adverse impact on the quality, safety and efficacy of biopharmaceuticals. Following are the highlights of our services for comparability studies:

Primary Amino Acid Sequencing
Intact & Reduced Mass Analysis
N- & C-terminal Sequence Analysis
Higher Order Structure Analysis
Biological Activity/Potency
Other Post-Translational Modifications

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Well-developed analytical methods are required, to test quality attributes such as identity, strength, purity and potency of biomolecules. There are two broad categories of analytical methods and these are listed below:

Compendial Methods
Non-Compendial Methods

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The Impurities should be quantified, characterized and their impact on the biological activities of the products should be evaluated according to ICH Q6B guidelines. There are four different categories of impurities:

Process-Related Impurities (cell substrates derived, cell-culture derived, downstream-derivde, etc.)
Product-Related Impurities(N- and C-terminal modifications, oxidation, deamidation, glycation, aggregation, etc.)

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A manufacturer developing biosimilar products must show that the biosimilar product is highly similar to the innovator product by extensively characterizing the structure, function and bioactivity in relation to the reference standard, innovator product and biosimilar product. We provide the following services for biosimilar analysis:

Comparability Studies
Similarity Studies
Stability Studies

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Why partner with Crystal Pharmatech

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Laboratory

Analytical laboratory is located at 2005 Eastpark Blvd in Cranbury, NJ.

Laboratories are located in Cranbury, NJ, a close proximity to both New York city and Philadelphia.

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Facility

~5300 sq ft laboratory space for R&D and ~3500 sq ft laboratory space for QC testing.

The R&D lab has ~5300 Sq.ft. space and another ~3500 Sq.ft. for QC facility. State-of-the-art laboratory equipped with modern instruments such as UPLC, HPLC, CE, LC-MS, etc.

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Personnel

Combined experience of more than 70 years in the analysis of biologics.

Our current analytical laboratory personnel has a combined experience of more than 70 years in the analysis and characterization of biologics.

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Market

Development of many mega-blockbuster biologics included in the top 10 selling biopharmaceuticals.

We have made significant contributions towards the successful development of many mega-blockbuster biologics which are also included in the top 10 selling biopharmaceuticals in the market.

Competitive Advantages

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Well-Characterized Biologics

Fundamental to the Chemistry, Manufacturing and Controls (CMC) of biopharmaceuticals development, detailed analytical characterization data is needed to meet regulatory requirements. Our experts use orthogonal protein analysis approaches that address key molecular and biological characteristics relevant to ensure the safety and efficacy of biopharmaceuticals. This approach includes the requirements of the ICH Q6B guidance such as total protein quantity, physicochemical properties, the extent of heterogeneity within a given sample and across batches, the intricacies of the primary structure including post-translational modifications (PTM), higher order structure and assessment of aggregation of biopharmaceuticals. Biopharmaceuticals are subject to degradation and our scientists are adept at developing methods addressing potential degradation pathways to establish Critical Quality Attributes (CQAs) of drug substance and drug product. With integrated formulation and stability teams, we can conduct forced degradation studies, determine what effect formulations have on higher order structure and use stability data to provide the next level of support if stability issues are observed.

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Meeting Regulatory Requirements

With a deep understanding of the latest regulatory developments, we can help our customers meet the regulatory requirements for authorization in all global regions, providing regulatory compliant data. Our experts will ensure the data meets the requirements of current Good Manufacturing Practice (cGMP), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), OECD GLP and other regulatory standards for investigational new drug application (IND) or new drug application (NDA) or biologics license application (BLA).

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Ensuring a Safe and Efficacious Product

An in-depth knowledge of biopharmaceutical is required for safety assessment. Our GLP capabilities include developing assays for pharmacokinetic (PK), toxicology, immunogenicity, efficacy, and biomarker studies from early discovery through the late-stage clinical studies and subsequent regulatory filings.

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Quality Data to Meet Milestones

Our thought-leaders have over 70 years of combined experience in biopharmaceutical development across a wide range of product types including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, cytokines (e.g., interferons), oligonucleotides, glycoproteins, biosimilars, etc. With broad capabilities in North America, Europe, Asia, etc. our experts deliver consistently to help clients meet and exceed product safety and efficacy requirements. We provide strong scientific and technical leadership coupled with project management and regulatory support, to drive your development and manufacturing programs forward.