LIFE SCIENCES

With over 20 years' of cGMP project delivery experience, we help clients efficiently navigate the complex design, regulatory, and safety requirements unique to FDA-licensed facilities.

No matter the therapeutic or scale we improve
speed-to-market and deliver compliant future-proof facilities.

lab technician taking measurements
life science project plans

INTEGRATED PROJECT DELIVERY

Unlike firms who push a “one size fits all solution,” our firm tailors project delivery to the unique needs of each organization. By doing so, we provide unmatched responsiveness along with industry-leading technical expertise. We work as strategic partners to support each client across the entire capital spend lifecycle.
 
From strategic investment planning and Greenfield designs to legacy plant debottlenecking and troubleshooting, no issue is too big or small.

Services + Expertise

COST-EFFECTIVE, FLEXIBLE FACILITIES

  • Site Selection

  • Capacity Analysis

  • Expansion Planning

  • Feasibility Studies

  • Process Scale-up

  • Plant Debottlenecking Studies

  • Automation + Industry 4.0 Planning

  • Energy Reduction Project Planning

  • Capital Cost / Operating Cost Estimates

  • Economic Alternative Analysis

  • Equipment Layout Optimization

  • Standardized Factory Design (SFD)

  • FEL 1 to IFC Design Packages

    • Process Engineering + Design​

    • Utility Engineering + Design

    • Plant Engineering + Design

  • Process Hazard Analysis

Our goal is to participate as long-term partners with clients to achieve optimal GMP manufacturing and bring products safely to market while finding innovative ways to lower costs.

We work with our clients to design highly flexible facilities and processes to support rapid scale-up and ever changing product pipelines. These advanced facilities support our clients' clinical and commercial production capabilities for their long-term goals as well as protect against significant capital investment to reconfigure.

Whether you’re in gene therapy, oral solid dosage (OSD) formulations, ointments + creams, API/small molecule manufacturing, advanced aseptic processing, biotechnology + vaccines, potent compounds, and containment we possess the technological know-how to help you succeed.

Engineer in Laboratory

> Cell and Gene Therapies (CGT)


Advances in cell and gene therapies (CGT) have created a rapidly growing market segment with the potential to dramatically change the competitive landscape. In response, we’ve created a cell and gene therapy team with the experience to help you make the right investments to expand your cell and gene therapy manufacturing capability.

For manufacturers, the new product types are creating challenges which range from initial scale-up to commercial manufacturing and daily operations. Our cross-discipline engineering and project delivery experts provide solutions to address these challenges while minimizing investment risk through a framework which integrates compliance facility, process, automation and project execution.

HIPP’s holistic approach empowers client to make the right facility and technological decisions to maximize yields, while meeting GMP regulatory compliance, and cost targets (per unit, capital and operational).

From front-end planning support such as:

  • Strategic investment consulting
  • Feasibility studies w/estimate (basis for decision)
  • Initial facility and layout requirements.

To detailed design, our process team leads the way with expertise in gene therapy, cell culture, single-use systems, and best practice solutions to deliver advanced therapy facilities no matter the scale.

Let us help you take your cell and gene therapy production to the next level and lift quality and compliance to meet the highest regulatory standards.




> Biotechnology + Biomanufacturing


We help clients stay ahead of the competition with our technical expertise and strong understanding of the changing dynamics in biopharmaceutical manufacturing.

Our biomanufacturing experts have experience with a wide range of biologics - including vaccines, protein therapeutics, conjugates, industrial enzymes, organic acids, oligonucleotides, amino acids, and DNA/RNA products.

By focusing on strategic business initiatives, we provide solutions for successfully delivering technically complex facilities that maximize the efficient use of capital, including:

  • Guaranteed project delivery with schedule and budget constraints
  • Improved asset utilization
  • Ensured FDA, EU and cGMP regulatory compliance
  • Reduced timelines for new products and production scale-up
  • Minimal impact to existing operations for legacy plant projects
  • Flexible biomanufacturing facilities with single-use and modular technologies

From laboratory and pilot scale production to commercial manufacturing, we will help you address the challenges of regulatory compliant biomanufacturing.




> Oral Solid Dosage


Our understanding of solid/liquid dose manufacturer’s unique needs has made us a global partner of choice for oral solid dosage (OSD) manufacturing projects.

We help clients develop and maintain an OSD manufacturing capability for success in the competitive global market.

We do so by providing engineering and consulting services that optimize process and facility productivity, including:

  • Flexible multipurpose facility design
  • Cost reducing continuous manufacturing solutions
  • Rapidly scalable production
  • High agile operations with rapid changeover solutions.
  • Regulatory compliance and risk evaluations
  • Safety by design for products and personnel, including highly potent APIs.

Let us put our expertise to work for you – by designing an agile facility that gives you the competitive edge in the global marketplace.




> API + HPAPI Manufacturing


Your active pharmaceutical ingredient (API) manufacturing project’s success is our priority. From potent compounds to Drug Enforcement Administration (DEA) Schedule V substances we’re focused on delivering superior results, every time.

Safety and regulatory compliance are key factors when dealing with highly potent APIs (HPAPIs) and oncological dosage forms. Our high-potency SMEs have the knowledge to help customers meet the challenges of protecting the production staff and the environment while also protecting the product.

From solvent based processing for bulk high-potency to sterile gels and OSD forms, our API experts provide services to help you achieve your API manufacturing goals, including:

  • Flexible multipurpose facility design
  • Technology Transfer
  • Debottlenecking and process scale-up
  • Cost reducing continuous manufacturing solutions
  • Rapidly scalable production
  • Safe and highly efficient material handling operations
  • Regulatory compliance and risk evaluations
  • HPAPI safety evaluations and containment/protection strategies
  • Safety by design for products and personnel, including highly potent APIs.

We can help you manufacture APIs, in a safe and contained manner that complies with all relevant regulations.

Enhanced by our uncompromising commitment to safety, quality and proven track record, we’re an expert partner you can trust to deliver facilities that produce APIs and HPAPIs.




> Fill Finish


Our experts can help your organization delivery a world-class parenteral drug manufacturing facility. Leveraging our insight into sterile fill and finish pharma processes, we design flexible cost effective aseptic manufacturing facilities.

We understand that in order to stay agile in a world dominated by numerous regulatory bodies, the ability to pivot quickly toward the future is a major competitive advantage. Known for innovative thinking, we help deliver manufacturing facilities with the flexibility to produce at various scales, multiple dosage forms and production methods.

From master planning to detailed design, we can help your organization design and implement future-proof solutions for fill-finish operations, providing services within facility design, process engineering and automation.




> Assembly + Packaging


Our experts can help your organization improve profitability with more reliable, flexible and efficient assembly and packaging (AP) operations both now and for future product use.

By holistically evaluating production, material handling, assembly, kitting, packaging and warehousing efficiencies are maximized through process integration, robotics and automation.

Our assembly and packaging experts can provide you with high performance, future proof solutions which meet regulatory requirements for environmental conditions, traceability, and security.




> 503A + 503B Compounding Pharmacies


Our experts can help your organization navigate the complexities of FDA cGMP and USP regulatory compliance while meeting business objectives.

We maximize value for outsourcing facilities by delivering cost effective solutions for cGMP compliant design of aseptic manufacturing in a timely manner. From master planning and facility design to cGMP gap assessments, we can help your organization capitalize on its strategic investment in compounding.




> Animal Health


Our animal health experts can provide your organization the expertise needed to meet the unique challenges regarding delivery of projects for animal health and research facilities.

Our knowledge of USDA-9, FDA-21, NIH, AAALAC requirements, BSL 1-3 experience and track record of successful project delivery have made us a key partner for animal health clients.

We will apply our industry knowledge and lean project execution approach to deliver strategic projects within the tight cost constraint often associated with animal health.

From new operations to legacy facility improvements, we apply industry knowledge and lean principles to deliver animal health projects within tight cost constraints





storage vessels
engineering checking pharma vessel
two pharma vessels