FiercePharmaManufacturing and FierceBiotechIT
The difference between outsourcing success and failure is often in CMO selection. In addition to having the basic tools and expertise required for your project, a CMO needs to be a good fit--in tune with both a client's corporate culture and processes; in sync with both scheduling and reporting needs.
Nice Insight finds that it's a good time for biologics-oriented CMOs: the market analyst anticipates increased demand from biotechs in custom manufacturing and process optimization. It projects a 75% increase in biopharma-related spending. Big pharma, on the other hand, appears to be cutting back to maintain profitability.
Frost & Sullivan research analyst Aiswariya Chidambaram told us via email that biopharmaceuticals "are likely to be the length and breadth of healthcare in the future." A strong R&D pipeline of its own, in addition to the work it provides clients, will be important to the success of CMOs in the future.
To develop this list, we approached Nice Insight, which has developed an analytical system for scoring and a growing database of CMO ratings based on client perception (CP) and awareness (CA). CP, explains Victor Coker, Nice Insight's director for business intelligence, is a relative ranking of each company based on communications that Nice analysts find in the public domain. CA ranks whether the market is aware of the company's services. (Nice Insight is a division of the New York-based marketing firm That's Nice, yet the research unit's analyses are completely independent from the its parent group and the parent's client relationships, Coker says.)
We asked Nice to prowl its CMO database to develop a Top 10 list based on 5 bread-and-butter contract manufacturing functions: process optimization; lyophilization; fill/finish; packaging; and stability, storage and testing.
Therapure is among the growing number of contract manufacturers now going by the "CDMO" moniker — using the "D" for development. The acronym is still not much in use, even though many CMOs regularly offer drug development services.
Therapure scored an 81% customer perception (CP) rating by Nice in Q3 — that's up 10% over Q2; up 19% over Q1.
The company's "Start with us. Stay with us," slogan reveals the Mississauga, Ontario, CMO's belief that clients want integrated services. Therapure services span development, manufacture, purification and packaging of rare and complex biotherapeutics, including hemoglobin-conjugated therapeutics and hemoglobin-based proteins to treat infectious diseases, cancer and anemia, according to the company's website. Therapure also provides process and test development, final release testing, filling and shipping services.
Therapure currently counts BioVectra, the Mt. Sinai Hospital Foundation and Stellar Pharmaceuticals among its clients. The privately held company, launched in 2008, boasts its own pipeline of therapeutic products, which include hemoglobin-conjugated products, modified proteins and monoclonal antibodies. Its protein-modification technology is in early stage development.
Xcelience talks about "molecular responsibility" in describing itself on its website. Nice gave it a 78% CP score, just three points behind Therapure. But Xcelience has a 50% CA rating compared with Therapure's 41%, providing some balance.
Xcelience has been busy: last month it expanded its clinical trial supplies manufacturing and packaging capabilities. In August, it teamed with Bend Research to speed drug product intermediates to early-phase trials. The company also expanded its Tampa, FL, headquarters, to accommodate the doubling of employees that it plans over the next three years.
The CMO provides formulation development and manufacturing solutions, and specializes in early-phase small-molecule development.
Pre-formulation, analytical method development and validation, GMP manufacturing, stability program management and its Chemistry Playbook, an aid for developing CMC solutions, are additional offerings.
Ben Venue Laboratories
Ohio-based Ben Venue specializes in sterile products —development and manufacture of liquid and lyophilized drugs. Its Bedford Labs unit focuses on critical-care and medically necessary generic injectables.
Ben Venue boasts proficiency in contract lyophilization and vacuum-drying of parenterals. It can provide materials from pre-IND through NDA submission.
Services include dosage form development, clinical manufacturing and commercial scale production for small molecule, biologics, cytotoxics and potent compounds.
Nice rates Ben Venue a 77% CP score in Q3, down two points from the previous quarter, but up 19 points from Q1.
Editor's Note: Ben Venue made known in August that it is exiting the CMO business. The group will not appear on any of our future lists of top CMOs.
Baltimore-based UPM specializes in formulation development among its service offerings. Other services include GMP manufacturing, tableting and capsule filling, stability test, scale-up and tech transfer and analytical services. The company is DEA-licensed for scheduled substances.
UPM announced late last month that it was readying to undertake a 50% expansion in production space.
President James Greg said in a September statement that the expansion answers increased customer requests for "production of compounds with more stringent environmental safety requirements." The addition will include one suite for handling of manufacturing processes associated with Occupational Exposure Band level 4 compounds and another suite for production of low-humidity compounds. Xcelodose-based API direct-fill-in-a-capsule services will also be available.
Its Q3 CP score from Nice is 77, tied with Ben Venue, but UPM's CA rating of 52% nudges it just beyond Ben Venue, with 43%.
Boehringer Ingelheim's fifth-place finish via Nice metrics stands in contrast to the Competitive Strategy Leadership Award 2011 in the European Biopharmaceutical Contract Manufacturing Market that it received from Frost & Sullivan recently. A big part of the F&S rating is weighted toward the 19 DNA-derived biopharmaceuticals that B-I has ushered to market on behalf of such companies as Amgen, Pfizer, MedImmune, Bayer Health Care and Merck Serono. R&D pipeline is a big factor, too, says research analyst Aiswariya Chidambaram.
F&S rating criteria include such metrics as leverage of competitive intelligence, execution of competitive strategy and impact on market share, so the ranking of any CMO is bound to differ between F&S and Nice Insight.
"The biggest competitive assets of B-I include its strong R&D portfolio with a well-defined in-house biologics pipeline spanning key therapeutic areas and the proprietary technologies (both in-house and acquired) for the development of mammalian and microbial contract manufacturing,"
Chidambaram said via email. In other words, being attached to a bona fide drugmaker has spillover advantages for the CMO arm. B-I, in fact, just announced a dedicated focus on biosimilars, benefits of which will surely find their way to the CMO.
Nice gives Boehringer Ingelheim a 76% Q3 CP and 59% CA.
Hospira One 2 One Global Pharmaceutical Services
"The comfort zone for parenteral commercialization" is how Hospira One 2 One labels itself on its website.
Within this comfort zone are custom commercialization services and contract manufacturing. So Hospira extends our initial list of bread-and-butter CMO functions on both ends.
In the custom commercialization house are product and specialized development services, international regulatory expertise and commercial services. The specialized development services span Phase II to launch and on to life-cycle management.
The contract manufacturing house, which has facilities around the world, provides such services as fill/finish, API-making, lyophilization, powder filling and syringe and cartridge filling. Also, the CMO has experience with biologics, cytotoxic drugs, betalactams and dispersed systems.
One 2 One has manufactured more than 25 large molecules and biologics for its clients, 15 of which are commercial products.
Hospira tied with Boehringer Ingelheim with a Q3 CP of 76%. One 2 One suffered in the CA category, however, ringing up 38% to B-I's 59%.
PCS is a steroid supplier and a contract manufacturer. As such, it specializes on a contract basis in steroid APIs and intermediates, custom fermentation and aseptic/sterile dosage form manufacturing.
Early work at PCS, a commercial group within Pfizer Global Manufacturing, involved the development of large-scale, cost-effective, synthetic routes for corticosteroids and hormonal steroids.
Nice rated PCS's CP at 76% for Q3; the same as Hospira and B-I before it. PCS pulls in with a 56% CA for Q3, compared with Hospira's 38%.
Kjell Johanssen was named to the newly created position of COO at Recipharm in August, to oversee ops development and growth of the contract manufacturing business. He had previously spent 20 years at AstraZeneca in senior manufacturing and supply chain roles.
Recipharm appears to be on a bit of a rally. It was just named a finalist in two categories in the European Outsourcing Awards 2011: "Most improved process/plant facility" and "Most effective drug discovery/development program."
The Nice scores reflect a rally: Recipharm's 76% CP rating for Q3 is a 6% rise over Q2 and a 20% rise over Q1. Companion CA scores show a similar trend: Q3's 50% is 13% higher than Q2's and 19% higher than Q1's.
The privately owned CMO offers drug development (clinical supply through formulation) and manufacturing services, in addition to services for EU import, regulatory assistance and logistics and packaging. It has facilities across Europe--in Sweden, France, the UK, Germany and Spain--and employs about 1,800. A development center in Solna, Stockholm, has its own GMP pilot facility for solid dose, semi-solids and sterile formulations.
North Carolina-based AAIPharma's services run the gamut of development and manufacturing, from formulation and analytical chemistry, microbiology and physical chemistry, to manufacturing of solid-dose and sterile products, packaging and distribution and support for stability, quality and regulatory matters.
AAIPharma has been in the CDMO business for 30 years, according to its website, and boasts 270 senior degreed scientists, including 20 PhDs. Its work encompasses the major therapeutic areas, and it has been involved in more than 500 IND submissions and 50 NDAs/ANDAs.
Its CP score dropped 5 points compared with Q2, but Q2 showed a 22% rise over Q1.
Cedarburg Hauser represents the 2009 union of Cedarburg Pharmaceuticals and Hauser Pharmaceutical Services. Its specialty is API development, especially early-stage and preclinical. Capabilities of the Grafton, WI, CMO include synthetic and organic chemistry for drug development, as well as natural product extraction, isolation and purification.
In August, Cedarburg Hauser adding Joseph Guiles as GM of INB Hauser Pharmaceutical Services in Denver.
Its CP rating of 75% in Q3 is a three-point boost over Q2 and an 11-point jump from Q1. Its CA scores run in the 20% to 30% range.