Biopharma Outsourcing Market Expands

For the broader pharmaceutical market, the top five activities that drug companies outsource are drug product manufacturing, packaging and labeling, distribution, small-molecule manufacturing, and holding and storage, according to Kate Hammeke of ISR Reports (1).

Service providers are expanding their services and capabilities to keep up with the high demand. The following are some examples of the growth the outsourcing industry is experiencing.  

Company developments, expansions, and acquisitions
The first few months of 2016 has seen an array of investments, expansions, and acquisitions in the pharmaceutical outsourcing market. Outsourcing companies appear to be looking to the early-phase development and clinical trial markets to increase their portfolios.

Austrianova completed a new facility, adding GMP cell-banking and fill-and-finish services for cell therapy products to its encapsulation services and technology, the company announced in a Jan. 25, 2016 press release (2). Austrianova offers the production of master cell and working cell banks (MCB and WCB) at the scale required for Phase I and II stage clinical trials using its isolator-based production facility. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCBs and WCBs are required for all cell therapy products like stem-cell therapies and biologics produced from cells such as vaccines, antibodies, and recombinant proteins.

LabConnect, a Seattle-based provider of laboratory services to -biopharmaceutical, medical device, and contract research firms, has built a new 5000-sq-ft biorepository in Johnson City, TN, that includes space for ambient, refrigerated, cold (-20 °C), and ultra-low temperature (-70 to -80 °C) storage as well as liquid nitrogen vapor phase storage (-190 °C) (3).

The facility includes storage capacity for more than eight million samples, validated and mapped backup freezers and generators, redundant HVAC systems, building and biorepository security systems, and a temperature monitoring system for freezers and refrigerators with a 21 Code of Federal Regulations Part 11 compliant audit trail. LabConnect also tracks sample locations and consolidates data within a centralized database.

Catalent Pharma Solutions announced on Feb. 2, 2016 (4) an investment of $4.6 million to expand its Singapore clinical supply facility by building GMP space for secondary packaging. The investment doubles the ambient storage space and quadruples cold-storage capacity, the company reports.

The site provides clinical supply services including project and supply-chain management, comparator sourcing, clinical label printing, secondary packaging, clinical storage, import/export management, importer of record service, and returns and destruction management services. It has served as a regional hub for studies in Australia, Singapore, Korea, Hong Kong, and other countries in Southeast Asia.

SGS, a bio/pharmaceutical analytical and bioanalytical contract solutions provider, announced on Jan. 19, 2016 that after the acquisition of Quality Compliance Laboratories in December 2015, its global network now offers chemistry and microbiology testing services for cosmeceuticals, natural health products, and medical marijuana from facilities in Canada (5).

New capabilities within the two facilities include an inductively coupled plasma-mass spectrometer and inductively coupled plasma-optical emission spectrometer for elemental impurities analysis, automated tablet dissolution apparatuses, flow-through USP dissolution apparatus, and Vitek for bacterial identification.

Vetter announced on Jan. 28, 2016 that the company’s Schuetzenstrasse multi-functional building in Ravensburg, Germany, has been completed on schedule and departments crucial to its operation have started to move in (6). The $32 million (€29 million) investment is part of a $331 million (€300 million) total investment strategy announced by the company in September 2015.

The continued demand by large and small customers for enhanced drug development services, as well as the need for ever-more future-oriented sophisticated IT systems to protect their data, created the need for the new facility, according to the company.

The 91,500-sq-ft, six-story building contains non-cGMP laboratories for development support, laboratory space for microbiological analysis, office workplaces for Vetter Development Service and IT, and a data processing center with enhanced security systems, including a safety cell that protects technology and data from external physical hazards in the event of an emergency.

Novasep is building a new synthesis laboratory and adding kilogram-scale production at its existing US facility in Boothwyn, PA (7). This extension will allow Novasep to offer both chemistry and purification services and to produce the initial kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials.

The new laboratory, equipped with reactors up to 50 L in size, will start operation in May 2016. It will offer cryogenic capacities and standard chemistry, as well as preparative purification chromatography processes.

PBOA expands membership
The Pharma & Biopharma Outsourcing Association (PBOA), founded in 2014, has been -advocating for the pharma outsourcing industry as the global market changes and expands. “We’re focused on working on the reauthorization of the Generic Drug User Fee Amendment (GDUFA), while keeping an eye on FDA’s Quality Metrics initiative, and helping make sure that CMO/CDMOs [contract manufacturing organizations/contract development and manufacturing organizations] are prepared for track-and-track/serialization regulations as they roll out in the United States and the European Union in the next few years,” says PBOA President Gil Roth.

In February 2016, PBOA expanded its membership (8). IDT Biologika and Ei SolutionWorks joined the PBOA as general members; 3M Drug Delivery Systems (DDS) joined as a sustaining member. Diego Romeu, manufacturing and supply chain director at 3M DDS, was also voted to a three-year term on the board of trustees, along with Rajan Puri, director of business development at Therapure, and Lee Karras, CEO of Halo Pharmaceutical.

“As we continue our mission to represent the CMO/CDMO industry before FDA, Congress, and other stakeholders, it’s critical that we increase our membership and provide a true voice for our industry,” said Roth. “We’ve been successful in bringing the CMO/CDMO perspective to issues such as GDUFA, quality metrics, and serialization, and we’re delighted to bring in new member companies and add fresh points of view to our Board of Trustees.”

References
1. A. Shanley, “Surveys Examine Outsourcing Trend,” Pharmaceutical Technology, Supplement: Partnerships in Outsourcing, 40 (13), pg 32-33
2. BioPharm Editors, “Austrianova Offers GMP Cell Banking and Fill/Finish Services,” BioPharmInternational.com.
3. LabConnect, “LabConnect Builds New Biorepository, Expands Services, Offers Absolute Sample Protection,” Press Release, Feb. 3, 2016, accessed Feb. 16, 2016.
4. Catalent, “Catalent Invests $4.6M to Further Expand Asia-Pacific Clinical Trials Hub in Singapore,” Press Release, Feb. 2, 2016, accessed Feb. 16, 2016.
5. SGS, “SGS Announces Expansion and Integration of Chemistry & Microbiology Testing Offer Following Canadian Acquisition,” Press Release, Jan. 19, 2016,  accessed Feb. 16, 2016.
6. Vetter, “Vetter Announces Completion of Multi-Functional Building for Development Service and State-of-the-Art IT,” Press Release, Jan. 28, 2016, accessed Feb. 16, 2016.
7. Novasep, “Novasep Adds Synthesis and Kilo Lab Extensions at US Facility,” Press Release, accessed Feb. 16, 2016.
8. PBOA, “PBOA Welcomes New Members and Trustees,” Press Release, Feb. 10, 2016, accessed Feb. 16, 2013.

Source