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New therapies, new technologies, global supply chain challenges, and political pressures draw pharma professionals to major industry event.
A version of this article was published in Pharmaceutical Technology Europe’s APIs, Excipients, and Manufacturing 2019 Supplement.
Emerging therapies, business and political stresses, aging facilities, supply chain transparency, and regulatory oversight are some of the issues the bio/pharma industry currently faces. Mergers and acquisitions on both the pharma and supplier sides of the market, pricing pressures for innovator and generic drugs, new technologies including artificial intelligence and the industrial Internet of Things, the globalization of supply chains, and rise of digital medicine are factors shaping decision making in the bio/pharma laboratory, manufacturing plant, and boardroom.
With complex issues facing the pharma industry, decision makers charged with developing and delivering drugs to market will gather in Frankfurt, Germany on 5–7 November 2019, for the annual CPhI Worldwide trade show.
The event, which in 2018 attracted more than 44,000 bio/pharma industry professionals from 165 countries to visit more than 2500 exhibiting companies, is an opportunity to meet with business contacts, learn about new technologies, and network with other drug development and manufacturing professionals in the industry (1). A review of the proposed 2019 agenda reveals the event will address key topics facing the pharma industry.
The exhibits and conference programme at CPhI represent a cross-section of bio/pharmaceutical development and manufacturing functions. Visitors work for a range of pharma business types including generic finished products pharmaceutical companies (16%), innovator finished products pharmaceutical companies (9%), contract service providers (15%), and distributors (14%). API producers, over-the-counter drug companies, nutraceuticals, pharmacy, academic, and other organizations round out the audience (1).
The 2019 event at the Messe Frankfurt exhibition centre in Germany will feature six events for APIs, excipients, and other ingredients (CPhI); contract services (ICSE); packaging (InnoPack); finished drug products (FDF); equipment (P-MEC); and bioprocessing (BioProduction), which are accessible through one visitor pass. A matchmaking service pairs buyers of bio/pharma ingredients, equipment, and services with exhibitors offering those products and services for onsite meetings. Free-to-attend conference programmes include Insight Briefings, a World of Pharma Podium, and Natural Extracts Podium.
In addition, event organizers will recognize innovation in development, manufacturing, distribution, and business in the pharmaceutical industry at the annual CPhI Pharma Awards ceremony.
Following a trend of previous years, mergers and acquisitions-both announced and finalized-look to change the composition of the pharma industry and may shift the way bio/pharma companies conduct research, development, and manufacturing, key considerations for visitors to CPhI Worldwide. Through the first half of 2019, both innovator and generic-drug companies announced deals to reposition their drug portfolios, strengthen their financial positions, or enter the emerging cell- and gene-therapy arenas.
Bristol-Myers Squibb’s (BMS’s) planned acquisition of Celgene will create a combined company with an early-stage pipeline of 50 potential therapies; BMS also sold its UPSA consumer health business to Taisho Pharmaceutical Holdings in July 2019.
AbbVie’s acquisition of Allergan, announced in June 2019, was positioned as a move to reduce reliance on Humira-which is scheduled to lose patent exclusivity in 2023-and expand the company’s focus to other therapeutic areas.
In August 2019, Bayer announced an agreement to divest its animal health business to Elanco Animal Health and acquire cell-therapy development company BlueRock Therapeutics in an effort to focus on life sciences.
Other major transactions announced or completed in 2019 include Pfizer (Array BioPharma and Therachon), Merck & Co. (Peloton Therapeutics and Tilos Therapeutics), Biogen (Nightstar Therapeutics), GlaxoSmithKline (Tesaro), Eli Lilly (Loxo Oncology), and Takeda Pharmaceutical (Shire).
The corporate restructuring of bio/pharma companies has implications for the supplier side of the market, which also witnessed announcements of business changes. Two prominent deals included moves by contract development and manufacturing organizations (CDMOs) to play significant roles in the cell- and gene-therapy markets.
In May 2019, Catalent (Stand 121A82, ISCE) completed a €1.08 billion (US$1.2 billion) acquisition of Paragon Bioservices, a viral vector development and manufacturing company for gene therapies with expertise in adeno-associated virus vectors (2). In July, the company completed the purchase the of vaccine manufacturing equipment and facility assets and assumed the leases of two Novavax product development and manufacturing facilities (3).
Also in May, Thermo Fisher Scientific (Stand 121C80, ISCE) purchased Brammer Bio, a gene- and cell-therapies CDMO, for approximately €1.53 billion (US$1.7 billion) in cash. The acquisition will become part of Thermo Fisher’s Pharma Services business (4).
Other deals involved the transfer of manufacturing assets from bio/pharma companies to contract manufacturers, signalling a shift to outsourcing of key development and manufacturing functions.
In August, Fujifilm Diosynth Biotechnologies (80B84, CPhI/Integrated Pharma Zone) acquired the Biogen Manufacturing ApS facility near Copenhagen, Denmark, adding a large-scale production facility with six 15,000-L bioreactors; an assembly, labelling, and packaging facility; and quality control laboratories and warehouses. Separately, the company announced a US$10-million investment to establish an integrated continuous processing facility for non-GMP biopharmaceutical manufacturing-including a 500-L single-use perfusion bioreactor and seven downstream processing units-at its Billingham, UK, location in June.
In June, Catalent announced that it agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy (5).
The company also announced an expansion of the its global spray drying capacity through an agreement with Sanofi Active Ingredient Solutions, which gives Catalent access to spray drying manufacturing equipment at Sanofi’s Haverhill, UK, facility. Furthermore, the company said it will invest up to €36.1 million (US$40 million) at its manufacturing facility in Winchester, KY, USA to increase the site’s formulation and controlled-release tablet and capsule manufacturing capabilities and capacity (6). In July 2019, Catalent Biologics started construction on a €101 million (US$112 million) packaging facility that includes vial, bulk filling, and syringe/cartridge lines (7).
Lonza Pharma & Biotech (Stand 121C10, ICSE) announced on 1 July 2019 an agreement to purchase a sterile drug product fill and finish facility in Stein, Switzerland from Novartis. The facility will be the first sterile product finish and fill facility in Lonza’s network for clinical supply and commercial launch (8). In addition, Lonza announced plans to add two highly potent API (HPAPI) production lines at its Visp, Switzerland site including the addition of two multi-purpose lines to the company’s existing capabilities for lab-scale to large commercial-scale HPAPI production (9).
In May, Thermo Fisher Scientific announced an agreement to acquire a GlaxoSmithKline drug substance manufacturing site in Cork, Ireland for approximately €90 million (US$100 million). The site contains 270 cubic metres of reactor capacity, 10 production buildings, an R&D pilot plant, and lab infrastructure to support process development, scale-up, and physical characterization of APIs (10). The company also plans to invest €135.3 million (US$150 million) at sites in Monza and Ferentino, Italy, and Greenville, NC, USA, to add capacity for sterile liquid and lyophilized product development and commercial manufacturing (11).
With the ongoing consolidation of bio/pharma companies, as well as pressure to get products to market faster, more drug development and manufacturing companies are turning to contract service providers for support of formulation, development, manufacturing, packaging, and distribution of innovator and generic drug products. The ICSE section of CPhI, located in Hall 12, will host more than 265 contract service providers, including analytical laboratories, clinical trial services, research services, formulation experts, manufacturers, and packaging services. In addition to meeting with current or potential suppliers, visitors to CPhI can hear panel discussions about trends in contract manufacturing, cell and gene therapy opportunities, and 3-D printing for personalized medicines at the ICSE Theatre in Hall 12. Insight Briefings will address analytical, formulation, and manufacturing functions, as well as sterilization, lyophilization, injectables and highly potent drugs, inhalation drugs, vaccines, and drug/device combinations.
Increased demand for generic drugs is pressuring companies to deliver more product at lower prices. At the same time, regulatory authorities are stepping up oversight to ensure quality. In 2018–2019, recalls of angiotensin II receptor blockers due to impurities detected in the API were a leading story. As regulatory authorities scrambled to identify affected medicines, quality of the drug-ingredient supply, as well as supply chain transparency were questioned.
The scope of manufacturing and materials requirements for orphan drugs are different compared with blockbuster drugs. Shorter approval cycles reduce the amount of time available for process development and validation, sourcing material suppliers, analytical method development, establishing quality programmes, and securing supply chains.
Several zones at CPhI Worldwide host exhibitors and conference programmes to meet pharma company needs for ingredients, processing equipment, packaging, and finished dose formulations.
The CPhI segment of the event in Halls 4, 6, 8, 9, and 10 hosts more than 1275 manufacturers and suppliers of APIs, excipients, fine chemicals and intermediates, natural extracts, custom manufacturing, and integrated pharma. For generic drug manufacturing, the FDF section in Hall 9 features more than 450 suppliers in the finished dosage supply chain including Big Pharma, contract manufacturers, out-licensing specialists, end-product distributors, and end-user agents.
In addition to the exhibits, free educational sessions include panel discussions on the therapies of tomorrow, the future of biosimilars, and artificial intelligence for drug discovery. Topics scheduled for Insight Briefings at the CPhI Theatre in Hall 6 include opportunities in emerging markets and China, data integrity, quality by design, biomolecule purification, and novel excipients. Other sessions will examine dry powder inhalation, cannabis-based drug development, plant-based ingredients, amorphous silica gel, bioavailability enhancement, and oligonucleotide manufacturing.
Manufacturing equipment is showcased in the P-MEC section in Hall 11, which also features LABWorld, a zone focusing on laboratory equipment and analytical biotechnology. InnoPack, also in Hall 11, features pharmaceutical packaging innovations. Panel discussions at the InnoPack–P-MEC Theatre will cover trends in sustainable pharma packaging and drug delivery devices, packaging and devices for biologics, and improving patient compliance and adherence through packaging/device innovations. Other topics include polymers for container closure systems, plastic vials and syringes, high viscosity/high volume drugs, pre-fillable syringes, particulate analysis, and new packaging and closure options.
As blockbuster monoclonal antibody drugs mature and biosimilars come to market, suppliers are challenged to improve processing systems. At the same time, the emergence of cell and gene therapies are generating research and investment excitement. Development, manufacturing, and approval challenges are significant. In addition, pricing and reimbursement issues may hinder patient access to these therapies.
To address the challenges for biologic-drug manufacturers, the BioProduction show, with more than 50 exhibitors in Hall 12, will feature exhibits and conference sessions.
Attending CPhI Worldwide
The scope of CPhI Worldwide requires advance planning to enable visitors to maximize their time at the event. The event organizers offer three registration packages: Visitor, VIP, and VIP Exclusive. Registration, travel, hotel, Visa information, and other details about attending the event can be found at www.cphi.com/europe.
1. CPhI, Post Show Report 2018.
2. Catalent, “Catalent Completes Acquisition of Gene Therapy Leader Paragon Bioservices, Inc. for US$1.2 Billion,” Press Release, May 20, 2019.
3. Catalent, “Novavax and Catalent Announce Closing of Strategic Partnership,” Press Release, July 31, 2019.
4. Thermo Fisher Scientific, “Thermo Fisher Scientific to Acquire Brammer Bio, a Leader in Viral Vector Manufacturing,” Press Release, March 24, 2019.
5. Catalent, “Catalent to Purchase Bristol-Myers Squibb Manufacturing Facility in Anagni, Italy,” Press Release, June 19, 2019.
6. Catalent, “Catalent Extends Global Commercial Spray Drying Capabilities in Europe,” Press Release, July 9, 2019.
7. Pharmaceutical Technology, “Catalent Breaks Ground at US$112-Million Drug Product Manufacturing Facility,” www.pharmtech.com, July 17, 2019.
8. Lonza, “Lonza to Acquire Sterile Fill and Finish Facility from Novartis,” Press Release, July 1, 2019.
9. Lonza, “Lonza to Expand HPAPI Development and Manufacturing Capacity,” Press Release, June 13, 2019.
10. Thermo Fisher Scientific, “Thermo Fisher Scientific to Acquire Manufacturing Site in Cork, Ireland, from GSK,” Press Release, May 16, 2019.
11. Thermo Fisher Scientific, “Thermo Fisher Scientific to Invest US$150 Million to Expand Pharma Services Capabilities,” Press Release, March 18, 2019.
Supplement: APIs, Excipients, and Manufacturing
When referring to this article, please cite it as Pharmaceutical Technology Editors, “Market Dynamics Drive the Agenda for CPhI Worldwide," Pharmaceutical Technology APIs, Excipients, and Manufacturing Supplement (October 2019).