THE DAWN OF BIOPHARMACEUTICALS CONTRACT MANUFACTURING

Biopharmaceutical companies rely on contract manufacturers to focus more on developing and marketing the latest drugs.

Manufacturing a product has challenges, including operational and technical restrictions. When we are talking about "Biopharmaceuticals," the name shows how complex the process is. Especially the production challenges for any pharma or biopharmaceuticals are longstanding and can't be ignored.

Biopharmaceuticals are complex life-saving drugs extracted from living organisms. Manufacturing biologics or pharma products involves strict regulations, sterile production environments, and controlling temperature, humidity, and other conditions.

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The strict manufacturing requirements are putting more pressure on biopharma companies as they are already facing challenges in tackling more than 7000 rare diseases and their drug developments.

Pharmaceutical manufacturers are switching toward more flexible factory operations to support the production of a wider variety of medical drugs and therapeutics. Rather than concentrating on large-scale bulk production, these manufacturers focus on more minor, highly-targeted treatments.

Biopharmaceutical companies are relying on contract manufacturers to focus more on developing and marketing the latest therapeutics rather than getting into the complex manufacturing process, including clinical trials and approvals.

According to a recent research report by Arizton Advisory Intelligence, The biopharmaceuticals manufacturing market revenue will cross $25 billion by 2027. The biopharmaceuticals market accounts for 35%-45% of the overall pharmaceutical industry. Currently, the demand for biopharmaceuticals is at an all-time high and is likely to increase further in the coming years. This rapid growth is expected to advance the expansion of the overall pharmaceutical industry.

In addition, the recent trend shows pharma & biotech companies greater reliance on CMO companies to scale up their blockbuster biologics. Pharma & biotech companies are experiencing difficulties enhancing manufacturing capacities to match the increase in demand for biopharmaceuticals. This allowed contract manufacturers to minimize the supply-demand imbalance and increase the manufacturing capacities of a wide range of biologics.

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WHY ARE BIOPHARMACEUTICALS IN HIGH DEMAND?

Biopharmaceuticals have evolved as the most dignified industry of science. Biopharmaceuticals, also known as biologics, lead to hope for cancer treatments, heart disease, Alzheimer's disease, diabetes, and rheumatoid arthritis. In 1982, INSULIN was the first biologics approved for therapeutic use, developed by GENENTECH and marketed by Eli Lily. Since its inception, biopharmaceuticals have come a long way and revolutionized the treatment of a broad spectrum of diseases. They continue to be in demand in all branches of medicines.

Biopharmaceutical drugs have been taking over chemical drugs as biologics have the potential to offer personalized and precise treatment. The demand for biopharmaceuticals is increasing due to the advantages of biologics compared to chemical drugs because bio-technically produced medicines are better at targeting suitable molecules and are highly efficient in treating severe diseases.

WHY IS THERE A NEED FOR BIOLOGICS CONTRACT MANUFACTURING?

Biologics are proteins and nucleic acids derived from biological sources. These are medical drugs produced using complex technologies and biotechnology. Biopharmaceutical molecules can be made up of more than 2000 atoms. Reproducing these complex structures at an industrial scale needs sophisticated manufacturing capabilities and technologically advanced production infrastructures.

Biopharmaceutical companies rely on contract manufacturing organizations (CMOs) to provide capabilities and skills as needed. The CMO has provided most of the company's production in some cases. However, the current market structure lacks the ability of CMOs to produce bio pharmacy, despite increasing demand for outsourcing, especially in mammalian cell culture technology and new modality. As companies face today's evolving industrial economy, they must first optimize their operations to unleash hidden features. Once that's done, pharma/biotech companies have four options: build, acquire, partner, or face the reality of outsourcing.

MAJOR REASONS FOR OUTSOURCING:

Risk hedging: Biopharma companies often outsource to offset risk and gain time to reach critical clinical trials or launch milestones and justify internal investments.

Insufficient capacity: Many new market entrants. Start-ups developing biopharma lack existing capacity. The same is true for some significant pharmaceutical companies migrating part of their pipeline to biopharma.

Investment hurdles: The biopharmaceuticals industry has high investment requirements. For example, a new biopharma facility (5001,000 kg of active ingredient or API per year) with a large stainless-steel container designed for mass production of biopharma has more than $ 250 million, more than four years. Lead time is required.

Lack of skills: Some experienced CMOs have strong technical skills in cell line development, process development, and scaling. These CMOs are well suited for developing production processes and can improve yields while lowering the cost of goods sold. CMO technology is one of the most important factors to consider when choosing an outsourcer, along with a track record of quality, compliance checks, and delivery flexibility.

Technology Shift: Two significant trends affecting the existing mammalian cell culture facilities are:

1) Polymer production is shifting to a high productivity platform that depends on cell expression, medium composition, and treatment modes in upstream and downstream treatments (with fed-batch culture). Continuous increase in disposable devices). Not all existing plants are ready for the destructive increase in productivity or the use of disposable items.

2) New biological modality in the pipeline of multispecific mAbs, viral vectors, oligonucleotides, peptides, etc., is driving biopharmaceutical plants into a multi-platform, multi-modality situation. However, most multi-product plants It is still in mono-modality, mono-platform configuration.

BIOPHARMACEUTICAL CONTRACT MANUFACTURING COMPANIES

The main reason companies operating as contract manufacturers (CMOs) are experiencing business growth in in-house commercial-scale vaccines by biopharmaceutical companies. This is due to the difficulty of manufacturing. Once a new technology is approved through the clinical phase, it will require a process that can be expanded later to meet increasing demand. To address these challenges, biopharma companies are left to the CMO to take responsibility for manufacturing complex therapies, allowing developers to focus on commercializing their products.

KEY COMPANIES ARE:

Boehringer Ingelheim:

Boehringer Ingelheim has biopharmaceutical activities at its center in Biberach (Germany), Vienna (Austria), Fremont (California, USA), and Shanghai (China). These include manufacturing marketable own-brand products (actilyse, metalyse, praxbind, etc.) and biopharmaceuticals for clinical trials. BI is also one of the world's leading companies in process development, pre-marketing, and commercial production of biopharmaceuticals for third-party industrial customers.

Lonza:

As one of the world's most respected contract development and manufacturing companies, the company is known for reliable, high-quality services, global capabilities, innovative technology platforms, and extensive experience. In 2019, the company provided manufacturing services for over 300 commercial molecules, supporting the development of over 700 preclinical and clinical molecules in small and large molecules and the launch of breakthrough autologous cell therapies.

Samsung Biologics:

The company has established an overseas subsidiary, Samsung Biologics America, Inc., in the US to ensure stable sales growth and overseas expansion. In addition, as evidenced by Moderna's DP production of mRNA vaccines, the company has achieved fruitful results in both the CDO and pharmaceutical (DP) businesses. The company's Samsung Bioepis is a biopharmaceutical research and development company engaged in developing and commercializing biosimilars. The company is a contract manufacturer specializing in mammalian cell-based antibody drugs, a significant component of the biopharmaceutical market.

KEY COMPANIES TO WATCH

AbbVie

AbbVie has over 30 years of experience as a contract manufacturer and pharmaceutical developer. The company helps domestic and global companies develop, manufacture, and scale biopharmaceutical products by leveraging its extensive experience in preventing common bottlenecks and reducing time to market.

Catalent

Catalent Biologics' services include drug development and manufacture, leveraging its proven expertise from pre-clinical to commercial production and supply of small molecules, vaccines, biologics, and biosimilars.

Emergent BioSolutions

Emergent BioSolutions offers to manufacture drug substances and products and packaging through launch and commercial supply pharma and biotech. The biologics technology platforms comprise microbial, viral, mammalian, plasma, and advanced therapies.

FUJIFILM

FUJIFILM offers CDMO services to pharma and biotech companies through its subsidiary FUJIFILM Diosynth Biotechnologies. The company provides comprehensive benefits for cell culture, microbial fermentation, and gene therapy. Its services include cell line development, process development, analytical development, and cGMP production.

Merck KGaA

The company is a leading provider of contract manufacturing and development services for gene therapy and viral vectors. Its offering spans small-scale toxicology and phase I materials to commercial-scale manufacturing and fill-finish. Its state-of-the-art facilities are highly equipped for gene and cell therapy's manufacturing and testing needs.

Pfizer

Pfizer CentreOne is a contract development and manufacturing organization under the parent company Pfizer and a leading supplier of specialty APIs. Its services include the development and manufacture of drug products and drug substances. Its core offerings include two primary areas of expertise: API and drug products with a specific focus on small molecules steroid and hormone intermediates and APIs, custom small API synthesis, and sterile injectables fill-finish.

Serum Institute of India

Serum Institute of India is a leading CMO that provides comprehensive manufacturing services for developing vaccines. Its R&D initiatives include developing better adjuvants, conjugate vaccines, monoclonal antibodies, heat stable vaccines, and others. AstraZeneca has signed a license agreement with SII, promising to supply 1 billion doses too low- and middle-income countries and 400 million doses by the end of 2020. In August 2021, Novavax signed a supply and license agreement with the Serum Institute of India for developing and commercializing COVID19 vaccine candidates.

WuXi Biologics

WuXi Biologics operates several state-of-the-art cGMP-certified APIs and pharmaceutical facilities in four countries. The current GMP API production capacity exceeds 90,000 liters (150,000 liters by the end of 2021) and has grown to 430,000 liters in five countries by 2024. WuXi Biologics has become a leading global supplier to partners and customers by implementing next-generation plant designs for multi-product plants, scale-out single-use bioreactor production schemes, and ongoing bioprocessing technology.

OTHER PROMINENT VENDORS

AGC Biologics
Ajinomoto
Albany Molecular Research (AMRI)
Asymchem
Biocon
Cobra Biologics
Charles River Laboratories
Goodwin Biotechnology
KBI Biopharma
Sanofi
Bavarian Nordic
Wacker Biotech B.V
Jubilant HollisterStier
National Resilience
Novasep
Kemwell Biopharma
Midas Pharma
Alcami
Cambrex
Pharmaceutics International
Singota Solutions
Thermo Fisher Scientific
Binexc
Canton Biologics
ChemPartner
Cytovance Biologics

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