Making Early-Phase Drug Development Faster, Better, and More Efficient
Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.
Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing
Nanomilling from Screening to Scale-up
Altasciences Continues Building Expansion with Additional Location in Philadelphia
Laval, Quebec, September 27, 2021 – Altasciences today announced the continued expansion of their formulation, manufacturing, and analytical services facilities in Philadelphia, PA. Altasciences, an integrated drug development solution company offering pharmaceutical and biotechnology companies worldwide a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services, launched a second building project to increase its capacity and meet the ever-growing needs of its clients.
Altasciences’ first warehouse expansion started earlier this year and is expected to be ready for use by the end of 2021. The 35,000-square-foot space, acquired in December 2020, is directly adjacent to Altasciences’ existing facility. The new space, with its 24-foot ceilings, will be configured to include a ~8,750-square-foot warehouse, a ~8,750-square-foot Grade C/D manufacturing area, and a 17,500-square-foot client-dedicated cGMP manufacturing area.
In addition, Altasciences has expanded into a new 53,000-square-foot, client-dedicated facility for formulation development and Phase I through to commercial manufacturing. This new project is expected to be completed in 2023.
“Completing these significant expansions and investment into both capacity and state-of-the-art technology will ensure that Altasciences can provide the drug development solutions that our customers need now and in the future. Altasciences prides itself on listening to what our clients need, and then adapting to their requirements,” explained Ben Reed, Executive Vice President of Operations.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Julie-Ann Cabana
Altasciences
+1 514 601 9763
jcabana@altasciences.com
Global Business Reports: Interview with Altasciences' CEO, Chris Perkin
The Bioequivalence of Fixed-Dose Combination Tablets of Bisoprolol and Ramipril and its Drug-Drug Interaction Potential
ISSUE NO. 19 — Hallucinogens, Psychedelics, Entactogens: Challenges Associated With Schedule 1 Therapeutic Development
Under the Controlled Substances Act (CSA) in the United States, drugs that have the potential to be abused are scheduled into one of five Classes or Schedules (CI-V) as controlled substances. The scheduling method makes a distinction between drugs that have abuse potential and are not approved for medical use (i.e., Schedule I) and drugs that are approved for medical use and have abuse potential (Schedules II-V). In the classification, the higher the number of the Schedule, the lower the abuse potential of the drug and the less restrictive the conditions regarding its distribution, storage, and prescribing.
Schedule I, or Class I (CI), drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse.
Recent research on psychedelics and entactogens, both of which are Schedule I, is beginning to demonstrate the potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status.
In Issue 19 of The Altascientist, we review:
- the regulatory environment and challenges (Drug Enforcement Administration
- the research site requirements associated with the development of Schedule I drugs for therapeutic
- required preclinical studies of Schedule I drugs
- required clinical studies of Schedule I drugs
- specialized clinical assessments of Schedule I controlled substances
- formulation, manufacturing, and analytical considerations for Schedule I drugs
AAPS Outsourcing Newsletter (Issue III): Spotlight on Dr. Anahita Keyhani, PhD, Senior Director of Scientific Operations, Mass Spectrometry, at Altasciences
CTS Clinical and Translational Science: The Bioequivalence of Fixed-Dose Combination Tablets of Bisoprolol and Ramipril and its Drug-Drug Interaction Potential
The Many Faces of Recreational Drug Use
The Issue of Opioid aBUSE
A growing public health concern, opioid abuse has been intensified by the COVID-19 pandemic.