Velesco Pharmaceutical is a provider of analytical procedure development, drug formulation, stability testing and consulting services to biotech and pharmaceutical companies. The company, founded in 2007 by former employees of Pfizer, supports the initial-stage activities of pharmaceutical companies.
In June 2009, Velesco opened a new facility to increase its manufacturing capabilities. Located in Kalamazoo Commerce Center, Michigan, the facility will manufacture clinical supplies to be used by pharmaceutical companies in their early phase trials.
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Facility
The 10,000ft2 facility is devoted to the manufacture of non-sterile cGMP clinical trial supplies for pharmaceutical companies that are into developing new medicines. Registered with the US Food and Drug Administration, the facility is suitable for filling oral powder into bottles and capsules, oral liquids, transdermal liquids/creams and ointments.
It also carries out the primary packaging and labelling of Phase I and Phase II lots as well as secondary packaging and clinical kit assembly.
Within the facility there is one clean room, two warehouses and ten offices. The total warehouse area is 2,500ft2, while the office and the manufacturing unit occupy an area of 2,000ft2 and 1,500ft2 respectively.
The clean room has two processing suites, each extending 120ft2. These suites will be equipped with a Schaefer10B over-encapsulation equipment, bottle cap torque applicator, powder pipettes, balances, automated filling equipment and blenders.
To test the drug product before its release, the facility will also add a GMP laboratory. The lab will be equipped with high-performance liquid chromatography, dissolution apparatus, a fume hood and stability chambers. It will be operational by October 2009.
To allow for a range of storage conditions, freezers and related equipment will also be validated and made available by October 2009.
Production
The facility will produce materials used for Phase I and Phase II clinical trials. Product offerings will include powder-in-capsule, powder-in-bottle, ointments and creams, oral and topical liquids, over-encapsulation for blinded studies and packaging. The facility will focus on manufacturing powder-in-capsule, powder-in-bottle, topical and non-sterile liquid dosage forms.
Process
The company has adopted a hand-filling method to insert bulk active pharmaceutical ingredients (API) material into hard or soft gelatine capsules or vials. The same is used for filling liquids into soft gelatine capsules or vials. Larger tablets are blended via a new over-encapusalation technology that avoids the need for additional processes.
The operations take place in real time. Similar to compounding in clinic, a continuous process takes place in Velesco. The lots are released in real time. Batches are shipped to the clinic immediately after the entire process is completed, within a day. The lot does not undergo any stability testing. The expiration date is set based on API stability while the beyond-use date is set based on the experimental study performed in the formulation lab.
Construction
The space for the new facility has been taken on lease. The facility already has a building that was previously used as GMP clinical manufacturing facility by Komodo Pharmaceutical Services, a contract manufacturing outsourcing company that specialises in over-encapsulation.
Additional expansions to the facility are not planned in the near future as it has been well built.
Expansion
Besides the new facility, Velesco has shifted its Ann Arbor laboratories to a larger laboratory space in Plymouth, Michigan.
The laboratory, part of the Michigan Life Science and Innovation Centre, will be used to accommodate Velesco’s increasing analytical and drug formulation service requirements. Velesco will spend approximately $500,000 to upgrade the facility over the next five years.
The Plymouth facility accommodates multiple tenants including start-up life science companies. These companies were commissioned when Pfizer had closed a significant R&D site in Ann Arbor in 2008.
